SYSTEMATIC REVIEW |
https://doi.org/10.5005/jp-journals-10005-2805 |
Herbal Mouthrinses for Prevention of Dental Caries in Children and Adolescents: A Systematic Review
1–3Department of Pediatric and Preventive Dentistry, Centre for Early Childhood Caries Research (CECCRe), Sri Ramachandra Dental College and Hospital, Sri Ramachandra Institute of Higher Education and Research (SRIHER) (Deemed to be University), Chennai, Tamil Nadu, India
4Department of Public Health Dentistry, Sri Ramachandra Dental College and Hospital, Sri Ramachandra Institute of Higher Education and Research (Deemed to be University), Chennai, Tamil Nadu, India
5Department of Oral Medicine and Radiology, Meenakshi Academy of Higher Education and Research, Chennai, Tamil Nadu, India
6Department of Biostatistics, Centre for Biostatistics and Evidence‑Based Medicine, Vellore, Tamil Nadu; Department of Research, Narayana Dental College and Hospital, Nellore, Andhra Pradesh, India
Corresponding Author: Muthu MS, Department of Pediatric and Preventive Dentistry, Centre for Early Childhood Caries Research (CECCRe), Sri Ramachandra Dental College and Hospital, Sri Ramachandra Institute of Higher Education and Research (SRIHER) (Deemed to be University), Chennai, Tamil Nadu, India, Phone: +91 9444045094, e-mail: muthumurugan@gmail.com
ABSTRACT
The primary aim of this study was to evaluate the effectiveness of herbal mouthrinses (HMR) on caries prevention in children and adolescents. In addition, this systematic review assessed its effectiveness in remineralization of white spot lesions, reduction of halitosis, and improving gingival and periodontal health in orthodontic patients and patients with special healthcare needs (SHCN). A comprehensive bibliographic search was conducted in PubMed, Cochrane Central, EMBASE, AMED, ProQuest, CINAHL, AYUSH, Digital Helpline for Ayurveda Research Articles (DHARA), and Clinical Trial Gov databases. A total of 3,918 titles were identified during the initial search. Of these, 32 studies were selected for quality assessment. A total of 5,038 participants from 10 countries were thus included in this review, with 22 (66.7%) studies conducted in India. All included studies were published between 2004 and 2021. Included studies investigated the effect of HMR on caries increments, which record decayed, missing, filled (DMF) [International Caries Detection and Assessment System (ICDAS)], decayed, missing, filled teeth/surfaces (DMFT/S), and incipient caries. Changes in bacterial count (Streptococcus mutans and Lactobacillus) and alterations in levels of Candida albicans from saliva or plaque samples were also reported. The effect of HMR on gingival and plaque indices among adolescents undergoing orthodontic treatment and children with SHCN was reported in two studies. The variance in the HMR formula across studies, short follow-up period, and limiting grade of evidence do not allow for conclusive evidence of the efficacy of HMR. This warrants high-quality randomized controlled trials (RCTs) with longer intervention periods involving children under 6 years to yield more conclusive results.
Keywords: Caries prevention, Herbs, Herbal mouthrinse, Streptococcus mutans, Systematic review
How to cite this article: Saikia AM, Sivasubramanian A, MS M, et al. Herbal Mouthrinses for Prevention of Dental Caries in Children and Adolescents: A Systematic Review. Int J Clin Pediatr Dent 2024;17(S-1):S100–S111.
Source of support: This systematic review was a funded project by the Indian Council of Medical Research (ICMR), Grant no.5/7/1708/CH/Adhoc/RBMCH2020.
Conflict of interest: None
INTRODUCTION
According to the World Health Organization (WHO) Global Centre for Traditional Medicine (GCTM), nearly 88% of all countries rely on traditional medicines, including herbal medicines (WHO 2020). Herbal products continue to gain popularity among patients and healthcare professionals worldwide (WHO). Evidence of natural products being used for the prevention and treatment of oral diseases backdates thousands of years ago in Western and Eastern societies.1 Numerous recipes for mouthrinses and toothpaste composed of natural substances can be found in the Ebers Papyrus.2 In 5000 BC, the Babylonians introduced ”chewing stick” which continues to be popular to date among communities in Asia and Africa.3-5 Herbal mouthrinses (HMR) are generally formulated with extracts of sanguinarine, propolis, neem, green tea, charcoal, clove, and miswak.6 Epidemiological studies revealed that miswak had strong anticaries effects7-9 while Galla chinensis was reported to be more effective in inhibiting demineralization and promoting remineralization.10,11 Though the mechanisms for these actions remain inconclusive, polyphenols in G. chinensis may potentially aid in delaying demineralization by stabilizing remnants in the organic matrix and blocking ion diffusion pathways.12,13 The remineralization properties of G. chinensis are attributed to polyphenol compounds that act as Ca2+ ion carriers.14-16
Dental caries remains the most common chronic disease of childhood across the globe. Its prevalence is significant, afflicting 60–90% of school-age children.17,18 An overall prevalence of 49.6% has been reported.19 A study among the South Indian population reported every fourth child to be affected by early childhood caries (ECC).20 In 2015, Hambire et al. conducted a randomized, blinded, controlled trial to assess 0.5% Camellia sinensis (green tea) extract, 0.05% sodium fluoride (NaF), and 0.2% chlorhexidine (CHX) mouthwashes and their effectiveness among aged 9–14 years. The results of the trial confirmed C. sinensis to have superior effects over NaF and CHX.21 Later, Thomas et al. compared green tea and CHX mouthwash against cariogenic microbes, such as Streptococcus mutans, Lactobacilli, and Candida albicans, in 4–6 years children reporting ECC. A significant decrease in S. mutans counts was reported with green tea, while CHX fared better in the reduction of lactobacilli.22 A meta-analysis conducted by Kommuri et al. in patients undergoing fixed orthodontic treatment reported CHX to be more effective against S. mutans; however, the results remain debatable as most included studies were assessed as low to moderate quality.23
Despite the reports of a few reviews11,24-27 on HMR, their benefits still remain inconclusive. There are no reports comparing the caries preventive effects of herbal vs conventional mouthrinses in children and adolescents to the best of our search. Hence, this systematic review aims to evaluate existing evidence on HMR and caries prevention in children and adolescents. Additionally, this review also intends to report the findings on efficacy in remineralizing white spot lesions, reducing halitosis, and improving gingival and periodontal health among orthodontic patients and those patients with special healthcare needs (SHCN).
METHODS
Protocol and Registration
This review was conducted in alignment with the recommendation of the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines.28 The protocol was registered priori in the International Prospective Register of Systematic Reviews (PROSPERO) (Registration No: CRD42021273019).
Eligibility Criteria
All studies were selected based on the following population, intervention, comparison, outcome, study design (PICOS) criteria:
-
Participants: All trials involving children and adolescents under 19 years of age, irrespective of SHCN, were included.
-
Intervention group: All trials assessing mouthrinses containing any herbal extract.
Comparison groups can include fluoride, CHX, or placebo-containing mouthrinses. Studies—all trials measuring at least one of the outcomes mentioned above (caries prevention, remineralization of white spots, change in bacterial counts, halitosis status, and gingival and periodontal health).
It should be noted that only randomized controlled trials (RCTs), quasi-randomized trials, and cluster randomized trials were included to synthesize high-quality evidence. Studies where participants were aged beyond 19 years were excluded. Included studies were limited to English language. Narrative reviews, laboratory-based studies (in vitro studies, animal studies), letters to the editor, case reports, observational studies, crossover trials, and conference abstracts with no subsequent full-text publications were excluded.
Information Sources and Literature Search
The search was conducted in the following databases for relevant studies from inception to January 2022: Cochrane Oral Health Group’s Trials Register, CENTRAL, MEDLINE via OVID, PubMed, CINAHL via EBSCOhost, EMBASE via OVID, Natural Medicines Comprehensive Database, ProQuest (Dissertations and Theses), ProQuest (Conference Proceedings), AMED, AYUSH Portal, Digital Helpline for Ayurveda Research Articles (DHARA), US National Library of Medicine (clinicaltrials.gov), and Clinical Trials Registry of India (CTRI—www.ctri.nic.in). Hand searching was performed in the following key journals: Community Dental Health, International Journal of Paediatric Dentistry, Pediatrics, Pediatric Dentistry, European Archives of Paediatric Dentistry, European Journal of Paediatric Dentistry, Pediatric Dental Journal, Community Dentistry and Oral Epidemiology, and International Journal of Clinical Pediatric Dentistry. The SHODHGANGA, the national dissertation abstracts database, was also screened for gray literature. Both Medical Subject Headings (MeSH) and free text using keywords—herbal, plant extracts, mouthrinses, mouthwash, dental caries, and oral health—were used for the search. The following filters were applied to these terms: clinical trial, English. The detailed search strategy is provided in Table 1. The following set of terminologies were used in AYUSH research portal and DHARA along with the general keywords: Ayurveda (Dantagata/Dantamulagata Roga, Mukha/Jiva/Oshtha Roga, Mukha/Jhiva/Osthharoga); Siddha (Vai/Naakku/Udhadu Noigal and Pal Eru Noi); Unani [Dental Carries (Taakkul E Asnan) and Stomatitis (Qula)]. The final search results from each database were imported and converted into research information systems (RIS) format in Zotero software before uploading into the Covidence (www.covidence.org) software.
| 40 | #13 and #37 |
| 39 | #13 and #37 |
| 38 | #13 and #37 |
| 37 | #34 and #35 and #36 |
| 36 | ((((((((dental caries) OR (dental plaque)) OR (gingival disease)) OR (periodontal disease)) OR (remineralization)) OR (bad breath)) OR (halitosis)) OR (medically compromised patients)) OR (orthodontic patients) |
| 35 | (((mouth washes) OR (mouthwash)) OR (mouthrinse)) OR (mouthrinses) |
| 34 | ((((((herbal) OR (herb)) OR (herbs)) OR (natural)) OR (organic)) OR (plant extracts)) OR (herbal medicine) |
| 33 | ((herbal) OR (herb)) OR (herbs) |
| 32 | (herb) OR (herbal) |
| 31 | #13 and #25 and #28 |
| 30 | #13 and #25 and #28 |
| 29 | #13 and #25 and #28 |
| 28 | #26 or #27 |
| 27 | Mouthwash |
| 26 | Mouthrinse |
| 25 | #16 or #17 or #18 or #19 or #20 or #21 or #21 or #22 or #23 or #24 |
| 24 | Oral health |
| 23 | Tooth decay |
| 22 | Halitosis |
| 21 | Orthodontic patients |
| 20 | Medically compromised |
| 19 | Remineralization |
| 18 | Gingival disease OR periodontal disease |
| 17 | Bad breath |
| 16 | Dental caries |
| 15 | #9 not #10 |
| 14 | (humans) NOT (animals) |
| 13 | #1 or #2 or #3 or #4 or #5 or #6 or #7 or #8 or #9 |
| 9 | Groups |
| 12 | Medicinal plant extracts |
| 11 | Plant extracts |
| 10 | Plant |
| 8 | Trial |
| 7 | Randomly |
| 6 | Herbal |
| 5 | Herbal medicine |
| 4 | Placebo |
| 3 | Randomized |
| 2 | Controlled clinical trial |
| 1 | RCT |
Study Selection
Initial screening of titles and abstracts was performed by two reviewers (AS and SA) independently against the eligibility criteria using Covidence software. Duplicates were removed. Full text of potentially included studies was retrieved and checked for eligibility and independently screened by the same two authors and grouped as “included” “may be” and “excluded.” The reasons for exclusion were recorded in the software. In cases of any disagreement regarding inclusion or exclusion of the study, arbitration was done through discussion with the experienced third review author (AG).
Data Extraction
Data extraction was performed independently by two reviewers (AS and SA) independently using a predetermined data extraction template. In instances of any missing or unclear reporting of data, the corresponding authors were contacted through e-mail.
Quality Assessment
The Cochrane Risk of Bias (RoB) tool29 was used to assess the quality of included studies. This tool consists of seven domains such as allocation concealment, sequence generation, blinding of participants and personnel, blinding of outcome assessors, incomplete outcome data, selective outcome reporting, and other sources of bias. The reporting assessment were “low risk,” “high risk” and “unclear risk.” The RoB for all included studies were performed in Covidence software by independently by both authors (AS and SA).
Summary Measures
The clinical outcomes evaluated in this review were caries increments in primary tooth surfaces [decayed, extracted due to caries, filled primary teeth/surfaces (deft/s)] permanent tooth surfaces [decayed, missing, filled teeth/surfaces (DMFT/S)] reported as change from baseline; change in bacterial count from saliva or plaque sample (S. mutans, Lactobacillus, or other cariogenic pathogens); remineralization of white spots in orthodontic patients as measured by the devices using laser fluorescence detection systems, change in halitosis status measured by any organoleptic devices, and change in gingival and periodontal health status measured by indices as a change from baseline.
Data-analysis
The heterogeneity across included studies were assessed based on study characteristics, methodological heterogeneity, and type of analysis.
RESULTS
The initial search identified 3,918 papers. After elimination of 256 duplicates, 3,662 papers were screened. This screening initially resulted in 356 full-text articles. After full-text screening, 182 articles were excluded for reasons such as wrong patient population—71; wrong study design—37; wrong intervention—25; only protocols—16; not in English language—9; ongoing studies—8; wrong outcomes—15; and study published twice—1. Among the remaining 174 full-text papers, 142 studies which reported any one of the desired outcomes were with overlapping age-group (children/adolescents and adults in the same study). These authors were contacted through e-mail to share the raw data for children and adolescents <19 years from their studies. Two authors replied. One author (Pratibha Taneja) shared the data from which we could not retrieve data <19 years. Another author (Vinayak Joshi) reported exclusion of children. Hence, no relevant data was obtained for further analysis from these 142 studies. Finally, 32 studies22,30-60 with 5038 total participants were included. Figure 1 illustrates the screening process using the PRISMA flow diagram.
Fig. 1: Preferred Reporting Items for Systematic Reviews and Meta-Analysis flow to illustrate the screening process
Study Characteristics
The characteristics of 32 qualified RCTs are presented in Table 2. The mean age ranged from 4 to 19 years were included in the present review. The studies included participants from 10 countries with majority of the studies 22 (66.7%) conducted in India and the publication years of included studies ranged from 2004 to 2021. Of 32 included studies, 30 reported on HMR and its effect on dental caries [using International Caries Detection and Assessment System (ICDAS), DMFT/S assessments]. Two studies report on HMR and its impact on bacterial count (S. mutans, and Lactobacillus, C. albicans). Changes in gingival and plaque scores of adolescents undergoing orthodontic treatment and among children with SHCNs were reported in two studies. None of the studies reported on the effect of HMR on remineralization and halitosis. The outcome measures reported in the included studies were debris index, calculus index, Oral Hygiene Index (OHI), ICDAS, bacterial counts, salivary pH, buffering capacity of saliva, glucan concentration, density of bacterial growth, and zone of bacterial inhibition from the saliva and plaque samples.
| No. | Study (author/year) | Country | Designduration | Participation/ inclusion criteria | Sample size | Study duration | Source of funding | Author’s conclusion |
|---|---|---|---|---|---|---|---|---|
| 1 | Al-Dabbagh et al./2016 | Iraq | Randomized control trial | 40 students (20 males and 20 females) aged 16–18 years, presence of at least 2 carious teeth | 40 (10 each group) | Salivary samples were collected at 3-time intervals: Before, immediately after use, and after 2 weeks of use | Nil | Miswak mouthrinse was found to be more effective in reducing the growth of cariogenic bacteria |
| 2 | Bajaj and Tandon/2011 | Karnataka, India | In vivo study: Double-blind randomized control trial | 1,431 students in the age-group 8–12 years | 1,431 | Baseline, 3 months, 6 months, and 9 months | Indian Council of Medical Research | The reports of the study stated no significant difference in the S. mutans count except for lactobacillus where Triphala had shown better results than CHX |
| 3 | Beheshti-Rouy et al./2015 | Iran | Double-blind randomized clinical trial | Female 11–14- year-old school children of Hamadan, Iran. Mean age not mentioned | 40 (35 each group) | Baseline: Plaque sample, after 21 days of intervention | Nil | The sage mouthwash was found to be effective in reduction of the S. mutans |
| 4 | Bhat et al./2017 | Karnataka, India | Randomized control trial | Children aged 8–14 years in Mangalore Residential School, Karnataka | 20 (10 each group) | Basline, 0.5 hours after rinsing and after 5 days | Nil | Daily use of herbal alternatives can be as effective and safe alternative to conventional mouthrinse |
| 5 | Chelli-Chentouf et al./2012 | France | Single blind, randomized, and placebo-controlled clinical trial | School children aged from 6 to 12 with and without caries | 20 (10 children with caries/10: children without caries | Saliva sample (1 mL) collected in sterile tube. The PH was measured immediately after collection using a calibrated PH meter | Nil | Hoggar miswak extract displayed a stronger antimicrobial effect |
| 6 | Dandekar and Winnier/2021 | Mumbai, India | A three-arm double-blind RCT | 300 children between the age-group of 8 and 13 years. With dmft/DMFT scores between 3 and 6 were selected for the study | 90 (30 each group) | Salivary S. mutans was evaluated at baseline, 7th day, and 21st day | Nil | Neem and mango mouthrinses were proven to be an effective alternative to CHX in children |
| 7 | Ferrazzano et al./2015 | Italy | In vitro and in vivo: Trial | 44 adolescents (24 males and 20 females) ranging from 12 to 18 years old | 44 (22 each group) | Baseline and on the 4th and 7th days: Saliva/plaque sample | Nil | P. lanceolata extract could represent a natural anticariogenic agent via an antimicrobial effect useful to control the proliferation of cariogenic flora |
| 8 | Hajiahmadi et al./2019 | Isfahan, Iran | Double-blind randomized controlled clinical trial | 64 children aged 6–12 years (35 girls and 29 boys) mean age of participants was 10.73 ± 2.82 years | 64 (32 each group) | Salivary counts of bacteria were determined at the baseline and after 2 weeks of intervention | Isfahan University of Medical Sciences, Isfahan, Iran | The effect of “green tea with xylitol” mouthwash on reducing the number of salivary colonies of S. mutans and Lactobacillus was found to be significantly higher than that of the “green tea” mouthwash |
| 9 | Hegde and Kamath/2017 | Maharashtra, India | Randomized control Trail | 75 school children aged 8–12 years. Mean age of the participants was 11.2 (SD: 0.93) years | 71 (24, 23, and 24 in groups 1, 2, and 3, respectively) | Nonstimulated whole salivary sample (2 mL) was collected at baseline and postrinsing | Nil | Green tea mouthrinse can be a promising preventive therapy worldwide for the prevention of dental caries. However, no significant difference was found between groups |
| 10 | Jain et al./2013 | Uttar Pradesh, India | Double-blind pilot study: Randomized control Trial | Pediatric patients aged 7–14 years, mean age not mentioned | 60 (20 each group) | Baseline prerinse and three postrinse saliva samples were evaluated for the changes in ph and mutans streptococci colony counts | Nil | The study affirms that both aqueous and ethanolic licorice extracts are potent cariostatic agents and are found to be palatable by child patients |
| 11 | Jain and Jain/2016 | Uttar Pradesh, India | Triple-blinded randomized controlled field trial | 15–17 years old school children in Ghaziabad, mean age not mentioned | 120 (30 each group) | Salivary and plaque sample were estimated prior to the use of mouthrinses and repeated again after a period of 24, 48 hours, 1 and 2 weeks Pre- and postrinse salivary samples are collected at each time interval | Nil | Both CHX and multi-HMR showed statistically significant reduction in the S. mutans CFU count, in terms of efficacy and substantivity both |
| 12 | Jauhari et al./2015 | Rajasthan, India | Randomized double-blinded controlled trial | 52 subjects in the age of 6–12 years | 52 (13 each group) | Caries activity and S. mutans counts were estimated using or a test and Dentocult SM Strip mutans kit prior to the use of mouthrinses and oil pulling technique and repeated again after a period of 2 weeks | Nil | HMR were found to be effective antimicrobial agent in reducing the bacterial colonization of an individual |
| 13 | Kamath et al./2020 | Karnataka, India | Double-blinded, placebo-controlled prospective interventional study | School children in the age range of 8–14 years with plaque scores and gingivalscores >1 and similar oral hygiene practices (89 boys, 63 girls) | 152 (38 groups each) | Baseline, 4 weeks after supervised mouthrinse and after 2 weeks of stopping the mouthrinse | Nil | The use of Aloe vera and tea tree oil mouthwashes can decrease plaque, gingivitis and S. mutans in the oral cavity in children |
| 14 | Megalaa et al./2018 | India | Double-blinded, placebo-controlled prospective interventional study | School children 8–12 years, 152 (38 each group) children were equally divided by simple randomization into four groups. The mean age in groups 1, 2, 3 and 4 was 11.92 ± 1.84 years, 12.15 ± 1.94 years, 12.16 ± 1.97 years, and 11.29 ± 2.16 years | 152 (38 each group) | Saliva sample baseline, 2 weeks washout period and at the end of 2 weeks wash out period | Nil | The results of the study suggest that HMR could be tried as an adjunctive anticaries agent against dental caries causing microorganisms |
| 15 | Mehta et al./2013 | Andhra Pradesh, India | Double-blind randomized clinical trial | 55 healthy children between 8 and 14 years | 55 (35 group A, 20 group B) | Phase 1 and phase 3 were the clinical trial periods of 10 days. Phase 2 was the washout period of 2 weeks. Baseline data were collected at the onset of phase 1 and the final value collected at the end of phase 3 | Nil | Freshol was found to be better than CHX in reducing the salivary mutans streptococci count and equieffective to CHX in altering plaque and gingival scores |
| 16 | Mishra et al./2019 | Rajasthan, India | Randomized clinical double-blinded study | 80 children of 8–15 years of age with decayed missing filled teeth (DMFT)/decayed, missing and filled teeth (dmft) >4 and no history of an orthodontic appliance and no medical history | 80 (20 each group) | Baseline, days 16, and 31 | Nil | This study concluded that V. vinifera had shown the lowest plaque reduction owing to its antioxidant and phytochemical properties. And P. granatum showed the maximum substantivity |
| 17 | Mon et al./2019 | Tamil Nadu, India | Parallel multiarm RCT | Schoolchildren aged 10–12 years, DMFT/deft score ≤3 | 100 (25 each group) | Baseline (T1), after 15 days (T2), and after 30 days (T3). Duration of the study was 1 month | Nil | Herbal water can be used in children instead of chemical mouthrinses to avoid any adverse effects |
| 18 | Nayak et al./2012 | Karnataka, India | Triple blind randomized field trial | 12–15-year-old school children of Belgaum city, 36 were male and 24 were female with the mean age 13.4 | 60 (36 and 24 groups 1, 2, respectively) | Baseline, 6 and 12 hours postrinsing | Nil | S. mutans counts significantly reduced 6 hours postrinsing for 80% of the children |
| 19 | Salama and Alsughier /2019 | Saudi Arabia | Randomized controlled clinical trial | Healthy children 4–5 years of age have primary dentition | 40 (20 each group) | Baseline, 2 and 4 weeks | Nil | Green tea extract showed promising effect in decreasing the count of salivary S. mutans and in the prevention of dental caries |
| 20 | Sharma et al./2018 | Ghaziabad, India | Randomized control trail | Healthy children between ages 6 and 12 years having one or more interproximal carious lesions, well into the dentin, visualized radiographically | 60 (15 each group) | Saliva samples baseline and again after 15 days of using the mouthrinse | Nil | CHX and fluoride showed statistically significant reduction in S. mutans count compared to herbal rinse |
| 21 | Singla et al./2018 | Bhopal, India | In vivo study: randomized control trial | 40 subjects were recruited from a local boarding school, age-group of 8–10 years with mean age of 9.7± 1.3, out of which 26 were males and 14 werefemales | 40 (10 each group) | Salivary samples on blood agar media at the end of 48 hours, and 7 days | Not mentioned | The aqueous extracts of the chosen herbal plants showed an acceptable antibacterial efficacy against oral streptococci |
| 22 | Somaraj et al./2017 | Karnataka, India | RCT (parallel group, placebo controlled | 240 schoolchildren (12–15 years old) e mean age of study participants was 13.86 ± 0.85 | 240 (80 each group) | Baseline, 6, and 12 months | Nil | Both herbal and fluoride were found to be equally effective and could be recommended for use in school-based health education program to control dental caries |
| 23 | Tandon et al./2010 | Manipal, India | Randomized control trail | 1,501 students in the age-group of 8–12 years, belonging to classes 4–6th were the subjects for this study | 1,501 (514, 495, and 492 in groups 1, 2, and 3, respectively | The Dsi (incipient caries) were done at 3, 6, and 9 months intervals from baseline to the caries assessment was done at 9 months interval from baseline | Funded by the Indian Council of MedicalResearch | No significant difference was found between the Triphala and the CHX mouthwashes |
| 24 | Thomas et al./2016 | India | A randomized, double-blind, active, and controlled clinical trial | 30 children aged 4–6 years. Mean age of the participants was 5 [standarddeviation (SD): 0.69] years | 30 (15 each group) | 2 mL saliva samples at baseline and after 2 weeks rinsing | Nil | From the results of our study, it can be concluded that green tea mouthrinse could be very good cost-effective mouthrinse |
| 25 | Vandana et al./2017 | Andhra Pradesh, India | A randomized, controlled, triple blind, and parallel repeated measure study | Female children aged 12–15 years selected from secondary school | 108 (27 each group) | Basline, 3 months, and 6 months | Nil | Stevia demonstrated very potent antiplaque and antigingivitis properties compared to other mouthrinses at the end of 6 months trial |
| 26 | Vilela et al./2020 | Brazil | Randomized control trial | 47 healthy children aged 5–12 years | 47 | Nonstimulated salivary sample (pre-/postrinse) | Individual scholarship (CAPES PROEX) | Both EGCG and green tea could be used as alternatives to CHX-based mouthwashes |
| 27 | Pinni et al./2018 | Andhra Pradesh, India | An in vitro and in vivo study | Children between the age-group of 6 and 12 years who were following a routine oral hygiene practice with dmft score 4 were screened without sex predilection | 30 (10 each group) | Salivary samples which were collected before and after (5 minutes) mouth rinsing | Not mentioned | Pomegranate Pericarp mouthrinse may be considered a potential anticaries mouthrinse |
| 28 | Oznurhan et al./2019 | Turkey | Randomized control trial | Children aged 10 –13 years (mean age: 11.33) with clinical picture of gingivitis. 90 individuals [48 girls (53.3%, 42 boys (46.7%)] | 90 (30 each group) | Saliva sample: Baseline 5 minutes (T1) and 60 minutes (T2) differences were calculated within 5–60 minutes (T3). Plaque sample for bacterial counts (CFU)/mL | Supported by CUBAP | Licorice was found to be more effective than CHX |
| 29 | Palit et al./2016 | Uttar Pradesh, India | Single-blinded (microbiologist) randomized control trial | Children between 8 and 12 years | 60 (20 each group) | Baseline ph of both the extract groups were compared to the ph at 10, 30, and 90 minutes | Nil | Results of this study showed that both types of aqueous extract of T. chebula may be used as potential anticariogenic mouthwash with acceptable taste in children |
| 30 | Thomas et al./2017 | Karnataka, India | Randomized double-blind active controlled clinical trial | 45 children aged 4 to 6 years with severe early childhood caries [S-ECC; based on decayed extracted filled (defs) score] were selected | 45 (15 each group) | A base-line and postrinsing nonstimulated whole salivary sample (2 mL) was collected and tested for the number of CFUs | Nil | The findings of this study indicate that green tea and garlic with lime mouthrinse can be an economical alternative to NaF mouthrinse both for prevention and therapeutics |
| 31 | Willershausen et al./2015 | Germany | Prospective randomized, double-blind clinical study | 40 patients (15 males, 25 females) mean age 16.1 ± 2.3 years: Fixed orthodontic patients with mild-to-moderate gingivitis | 40 (20 each group) | Saliva/plaque baseline, 4, 8, and 12 weeks |
Nil | HMR, used as an adjunct to mechanical oral hygiene measures was found beneficial for gingival health in patients wearing fixed orthodontic appliances |
| 32 | Dahal et al./2018 | Nepal | Randomized controlled clinical trial with parallel groups study: Triple blinded | 82 visually impaired students of age 4–20 years from Shree Purwanchal Gyanchakshu Vidhyalaya, Dharan, Nepal | 60 (20 each group) | Baseline and follow-up study visit after 2 weeks | Nil | Within the limitation of this study, herbal mouthwash could be useful in management of gingival health among visually impaired children |
Herbal extracts analyzed in the included studies22,30-60 were mainly derived from Azadirachta indica (neem), Terminalia chebula (black-myrobalan or kadukai), Salvadora persica (miswak), Plantago lanceolata (ribwort plantain—a species of flowering plant), Punica granatum (pomegranate), Vitis vinifera (wine grape), Glycyrrhiza glabra (licorice), Aloe barbadensis miller (Family: Liliaceae—Aloe vera), Phyllanthus emblica (amla), Allium sativum (garlic), Zingiber officinale (ginger), Mangifera indica (mango), Psidium guajava (guava), Salvia officinalis (Family: Lamiaceae—sage), Stevia rebaudiana (stevia) and other polyherbal formula that includes Triphala (polyherbal medicine including plant species Emblica officinalis, Terminalia bellerica, and T. chebula). The control groups were gold standard CHX or normal saline or placebo or the comparison among the other herbal preparations. The duration of intervention ranged from immediate prerinse vs postrinse or baseline comparison with various follow-up periods which varied among each study with minutes, weeks, days, and months.
Quality Assessments of Studies
Among the 32 included studies, about 16 (50%) were of “low risk” and 1 (3.1%) study assessed as “high risk” based on their randomization process and incorrect random sequence generation. The assessment of allocation concealment showed that about 15 (46.9%) and 6 (15.6%) were categorized under “low risk” and “high risk” category, respectively. Nearly, 16 (50%) studies were rated as “low risk” while 1 (3.1%) study rated as “high risk” for the domain—”Blinding of participants and personnel for all outcomes.” Figures 2 and 3 represent the risks of bias assessment for the included studies.
Fig. 2: Risk of bias graph
Fig. 3: Risk of bias summary
Descriptive Analysis
The detailed included studies characteristics are provided in Table 2. Table 3 represents descriptive summary including statistical analysis between the intervention and comparison group.
| Caries status | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Caries increments | Change in bacterial count | |||||||||
| No. | Study (author/year) | Intervention | Comparison | DMFT(S)/dmft(s) | ICDAS | D(si) | SM (CFU/mL) | LB (CFU/mL) | CA (CFU/mL) | Authors estimated RoB |
| 1 | Al-Dabbagh et al./2016 | Miswak MW + OTP Miswak TP ordinary TP (OTP) |
Saline + OTP | ND | ND | ND | > | > | ND | Low |
| 2 | Bajaj and Tandon/2011 | Triphala MW (0.6%) | CHX (0.1%) (+ control), distilled water (–control) | ND | ND | ND | NS | > | ND | Low |
| 3 | Beheshti-Rouy et al./2015 | Sage (stevia) 5% | Normal saline | ND | ND | ND | > | ND | ND | High |
| 4 | Bhat et al./2017 | Mango leaves MR (2%) | CHX (0.12%) | ND | ND | ND | > | ND | ND | Low |
| 5 | Chelli-Chentouf et al./2012 | Miswak | Placebo group | ND | ND | ND | > | ND | ND | Low |
| 6 | Dandekar and Winnier/2021 | Neem MR Mango MR |
CHX (0.12%) | ND | ND | ND | > | ND | ND | Low |
| 7 | Ferrazzano et al./2015 | P. lanceolata | Placebo group | ND | ND | ND | > | ND | NS | High |
| 8 | Hajiahmadi et al./2019 | 0.5% green tea | 20% xylitol + 0.5% green tea | ND | ND | ND | < | ND | ND | High |
| 9 | Hegde and Kamath/2017 | Green tea extract (0.5%) MR Combination MR: Thermokind |
CHX (0.12%) | ND | ND | ND | NS | ND | ND | Moderate |
| 10 | Jain et al./2013 | Aqueous licorice mouthwash (15%), ethanolic licorice mouthwash (3.75%) | CHX (0.12%) | ND | ND | ND | > | ND | ND | Low |
| 11 | Jain and Jain/2016 | HMR containing active ingredient as mixture of garlic powder, aqueous extract of amla (gooseberry), and organic solvent-based extract of ginger (20 mg each), essential oil containing menthol, and eucalyptol, fluoride containing 0.2% NaF | CHX mouthrinse (0.2%) | ND | ND | ND | > | ND | ND | Moderate |
| 12 | Jauhari et al./2015 | HMR containing active ingredient as S. persica (5 mg), oil pulling, fluoride mouthrinse containing 200 ppm NaF | Distilled water | ND | ND | ND | > | ND | ND | High |
| 13 | Kamath et al./2020 | Tea tree oil (0.5 gm), Aloe vera | 0.2% CHX (positive control), distilled water (negative control) | ND | ND | ND | > | ND | ND | Low |
| 14 | Megalaa et al./2018 | Sodium fluoride rinse 0.05%, herbal ethanolic extracts of tulsi (4%) | Black myrobalans 2.5% | ND | ND | ND | > | ND | ND | High |
| 15 | Mehta et al./2013 | Freshol | CHX gluconate (0.156%) | ND | ND | ND | > | ND | ND | High |
| 16 | Mishra et al./2019 | P. granatum, T. chebula, V. vinifera | 0.2% of CHX | ND | ND | ND | > | ND | ND | High |
| 17 | Mon et al./2019 | Herbal water, ozone water, CHX | Water | ND | ND | ND | > | ND | ND | Low |
| 18 | Nayak et al./2012 | T. chebula | Placebo control | ND | ND | ND | > | ND | ND | High |
| 19 | Salama and Alsughier/2019 | OHI + green tea extract (8 mL/day) | OHI | ND | ND | ND | > | ND | ND | Low |
| 20 | Sharma et al./2018 | 10 mL of herbal (HioraR), 0.2% CHX gluconate (HexidineR), NaF | Plain water | ND | ND | ND | < | ND | ND | High |
| 21 | Singla et al./2018 | Pomegranate extract, grape seed extract, guava extract | Distilled water | ND | ND | ND | > | ND | ND | High |
| 22 | Somaraj et al./2017 | Herbal MR (Freshol), 0.2% Fluoride | Mint flavor added in distilled water | NS | ND | ND | ND | ND | ND | Low |
| 23 | Tandon et al./2010 | Triphala (0.6%) | CHX (0.1%) (positive control) | NS | ND | ND | ND | ND | ND | Low |
| 24 | Thomas et al./2016 | Green tea | CHX (0.2%) | ND | ND | ND | > | < | ND | Moderate |
| 25 | Vandana et al./2017 | 10% stevia | 0.05% NaF, 0.2% CHX gluconate; placebo | ND | > | ND | ND | ND | ND | Low |
| 26 | Vilela et al./2020 | Epigallocatechin-3-gallate (EGCG) | Green tea | ND | ND | ND | > | > | ND | Moderate |
| 27 | Pinni et al./2018 | Pomegranate pericarp extract (PPE) | 0.2% CHX (positive control) | ND | ND | ND | > | ND | ND | High |
| 28 | Oznurhan et al./2019 | Licorice | CHX (CHX) | ND | ND | ND | > | ND | ND | High |
| 29 | Palit et al./2016 | 10% hot aqueous T. chebula extract, cold extract of T. chebula | Distilled water (negative control) | ND | ND | ND | > | ND | ND | Moderate |
| 30 | Thomas et al./2017 | Green tea | Garlic with lime mouthrinse | ND | ND | ND | > | > | NS | Low |
| Gingival and periodontal health during orthodontic treatment | ||||||||||
| No | Study (author/year) | Intervention | Comparison | PI | GI | PD | SM (CFU/mL) | LB (CFU/mL) | CA (CFU/mL) | Authors estimated RoB |
| 31 | Willershausen et al./2015 | Parodontax© | Placebo | SD | > | NA | NA | NA | NA | Low |
| Gingival and periodontal health among children with SHCNs | ||||||||||
| 32 | Dahal et al./2018 | Herbal MR | CHX (+control) placebo (–control) | > | > | NA | NA | NA | NA | Low |
>, significant reduction; <, lower than; MR, mouthrinse; NA, not applicable; ND, no data available; NS, no significant difference; OTP, ordinary toothpaste; OW, ozone water
DISCUSSION
The primary aim of this study was to assess the effects of HMR in caries prevention. The results of the 32 included trials involving 5,038 children and adolescents affirms a positive effect of HMR in controlling caries and altering bacterial levels. Of the 32 included studies,22,29-59 22 trials were conducted across India, 2 in Iran, 1 each in Germany, France, Italy, Turkey, Brazil, Iraq, Saudi Arabia, and Nepal. Our analysis reported 27 trials evaluating bacterial counts (S. mutans, Lactobacillus, and C. albicans) as outcome assessment while the effects of HMR on caries increment using indices such as DMFT and OHI were analyzed in five trials. Two RCTs evaluated plaque and gingival health using Plaque Index (PI) and Gingival Index (GI).
Secondary aims of the review were to determine the efficacy in remineralizing white spot lesions, reducing halitosis, and improving gingival and periodontal health among patients undergoing orthodontic treatment and with SHCN. Our analysis revealed one RCT conducted by Willershausen et al. that assessed the “effect of HMR (Parodontax) on gingival health in patients (mean age-group of 16 ± 2 years) undergoing fixed orthodontic appliances.” In this study, the subjects were examined at 4-week interval for a period of 3 months. The results of this double-blinded study established favorable beneficial outcomes in gingival therapy among children undergoing fixed orthodontic appliances when used in adjunct with regular oral hygiene measures.58 We found one trial evaluating the gingival health using plaque and gingival scores among adolescents with SHCN.61
Additionally, this review also intended to report included studies involving children only below 6 years. Our analysis reported two trials conducted among 4–6 years age-group assessing the effectiveness of green tea compared to NaF and CHX on primary dentition. Both trials recommended the use of green tea and garlic-lime mouthrinse as an economic alternative to CHX and sodium flouride mouthrinse. However, the short duration of intervention period could be a subject of caution. Nevertheless, these results suggest that use of HMR such as green tea and garlic-lime mouthrinse can reduce the bacterial levels in primary dentition.
Herbal Formula and Concentration
Although, the most common herbal component used across included studies was green tea,22,37,55,56 miswak30,34 and Tulsi were also tested in more than one study. The wide range of herbs assessed across study is a concern to establish solid evidences. Whether a single herb is more effective than a combination of herbs, needs further investigation.
Evaluation Period
Our reports affirm most trials having short evaluation period. The period of follow-up for HMR intervention ranged from 60 minutes to 9 months. On an average, 2 weeks regime have been followed to assess the efficacy of HMR while few studies had an evaluation period beyond 9 months. Due to the wide range of herbal components used as mouthrinses across study, the estimated period required to conclude its efficacy is still unknown. We noted that most studies comparing herbal to CHX mouthrinse had an average follow-up period of 2 weeks. While this is contrary to the American Dental Association which recommends a minimum of 6 months to establish the effectiveness of any product.62
Level of Evidence
Overall RoB across studies was low. The RoB report for all included studies revealed less than 5% “attrition bias.” All included studies reported no “reporting bias.” We observed several studies with small sample size. This can potentially lead to greater variability and skewing of findings. Hence, the overall robustness of the included RCTs findings is moderate. The daily use of chemical and synthetic products has been a subject of concern among the general population, researchers, and clinicians and paving way for herbal alternatives. Mounthrinses as an oral hygiene aid can be an effective alternative and adjunct to tooth brushing specifically in children who lack motivation, manual dexterity, and need supervision. Even though, CHX mouthwash has remained gold standard due to its substantivity, antiplaque, and antimicrobial efficacy, its shortcomings are staining, discoloration, altered taste sensation, mucosal desquamation, impaired wound healing, anaphylactic reactions, and antimicrobial resistance.61 Its long-term effects and safety for use in children has not been examined. Moreover, the unacceptable taste of CHX experienced by children is another concern.63
Strengths, Limitation, and Direction for Future Research
To our knowledge, this is the first systematic review to assess the effects of HMR on caries increments in children and adolescents. The reviewers further attempted to gather evidence on the effect of HMR on halitosis, gingival and periodontal health, and its remineralization potential. The review explicitly assessed various formulations of HMR. The reviewers also used the “Covidence” software to conduct the search, screening, data extraction, and assessment of study quality. The limitation of the review could be the exclusion of possible data of RCTs with overlapping age groups beyond 19 years due to nonavailability of precise data for the included age. Another limitation is exclusion of trials published in languages other than English.
To determine and establish one or combination of effective herbal formula, long-term robust trials are recommended. Thus, the efficacy of the most superior HMR could be compared with CHX and fluoride mouthrinses to affirm its future use. Furthermore, future research is warranted to evaluate the efficacy of the herb against chemical mouthwash, pertaining to both positive and negative effects, at various levels of concentrations. The results of such research will aid us to understand and conclude if HMR could be recommended as definite alternative to chemical mouthrinses. Indices such as ICDAS can be used to assess noncavitated lesions in young children. Further research should attempt to find the effectiveness of specific formulations of HMR suitable for use in children under 6 years to reduce the burden of ECC.
CONCLUSION
Results of this systematic review suggest that HMR may be effective in altering microbial levels among children and adolescents. Our analysis found no RCTs that evaluated the effect of HMR on halitosis and remineralization potential. The variance in HMR formula across studies, short follow-up period and limiting grade of evidence do not allow for conclusive evidence in efficacy of HMRs. The results of this review warrant robust RCTs designed to assess the effectiveness of different HMRs in preventing ECC among children under 6 years old.
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