Comparative Evaluation of Effectiveness of TheraCal LC, MTA, and Calcium Hydroxide in Direct Pulp Capping in Primary Molars: Randomized Clinical Study
Corresponding Author: Shruti Jha, Department of Pediatric and Preventive Dentistry, Subharti Dental College and Hospital, Swami Vivekanand Subharti University, Meerut, Uttar Pradesh, India, Phone: +91 8114791594, e-mail: email@example.com
Introduction: This study was performed to evaluate the clinical and radiographic effectiveness of TheraCal light cured (LC) comparison to mineral trioxide aggregate (MTA) and calcium hydroxide in direct pulp capping of primary molars over a period of 9 months.
Materials and methods: A total of 90 primary molars from children aged between 5 and 8 years were included in this randomized clinical study based on inclusion and exclusion criteria and were randomly divided into three groups—group I, TheraCal LC; group II, MTA; and group III, calcium hydroxide. Direct pulp capping (DPC) was performed in noncontaminated pulpal exposure with hemostasis achieved within 2–3 minutes followed by restoring the tooth using glass ionomer cement (GIC). Subjects were followed up at 3, 6, and 9 months for clinical and radiographic evaluations.
Results: At 9 months of follow-up, the overall success rate of direct pulp capping in groups I, II, and III were 60%, 72.41%, and 48.14%, respectively. Intergroup comparison showed nonsignificant differences (p >0.05).
Conclusion: The outcomes of this study suggest the limited success of direct pulp capping in primary molars. However, among the three materials used in this study, MTA comparatively had better results.
How to cite this article: Jha S, Namdev R, Singhal R, et al. Comparative Evaluation of Effectiveness of TheraCal LC, MTA, and Calcium Hydroxide in Direct Pulp Capping in Primary Molars: Randomized Clinical Study. Int J Clin Pediatr Dent 2023;16(S-2):S213–S219.
Source of support: Nil
Conflict of interest: None
Keywords: Direct pulp capping, TheraCal LC, Primary molars
The dental pulp is a loose connective tissue enclosed within rigid dentin walls. Caries, trauma, or mechanical reasons, can cause pulpal exposure, which subsequently can lead to severe pain and infection. If the condition is not entertained properly, it may progress to apical periodontitis, which eventually requires root canal treatment or extraction. Conservative approaches like pulp capping can be attempted to preserve the pulp vitality and thus extensive treatment can be avoided. This will also stimulate reparative dentin formation and preserve the tooth as a functional unit.1 When the pulpal exposure is <1 mm and bleeding stops within 3 minutes, it indicates that the pulp is vital and healthy. In this scenario, direct pulp capping can be done, in which a suitable medicament is placed directly over the exposed pulp.2 For a successful outcome of direct pulp capping it is necessary to do proper case selection and have an appropriate material placement with an acceptable seal, biocompatibility, and antimicrobial properties (Asgary et al.).3 Success rates of 87.5–95.4% have been shown with direct pulp capping in permanent teeth.4 However, the success is limited when it comes to primary teeth. Literature confirms that the poor prognosis of direct pulp capping in primary teeth is because of the presence of undifferentiated mesenchymal cells, which in response to inflammatory reaction differentiates into odontoclast cell, which induces internal resorption.5
Calcium hydroxide has been considered the “gold standard” pulp capping material in the permanent dentition. Its antibacterial properties and ability to raise pH and induce the formation of reparative dentin make it the most commonly used material on this subject.6 Though being a gold standard material, it does have certain drawbacks including the lack of innate adhesive and sealing abilities, poor physical properties, dissolution over time, and associated tunnel defect in the dentinal bridge.7
The MTA, a calcium silicate-based material, overcame the limitations of calcium hydroxide-based material and has been shown to ameliorate the overall result in direct pulp capping.7 It has several advantages including its antibacterial and biocompatibility properties, high pH, radiopacity, and its ability to aid in the release of bioactive dentin matrix proteins.8 Hydrophilic particles of MTA hardens in the presence of moisture and lead to improved mechanical properties. This material as a potential direct pulp capping agent has also shown success in primary molars.9 Regardless of being a favorable material, its use is limited due to prolonged setting time, difficult handling properties, washout of material from the site of application, and tooth discoloration associated with gray MTA.2
In order to overcome the limitations of MTA, a new light-cured, resin-modified, calcium silicate-filled base/filler material, TheraCal (LC Bisco) was introduced in the year 2011.7 Unlike MTA, its light-curable formulation causes immediate polymerization and reduced treatment time influencing pediatric patient cooperation. As the material sets it releases calcium hydroxide as a hydration byproduct and creates an alkaline environment which induces apatite formation followed by new dentin production and promotes cell growth and cell proliferation.2 In a study conducted by Gandolfi et al., it was found that calcium ion release was higher with TheraCal when compared with ProRoot MTA and calcium hydroxide. TheraCal also showed lower solubility and water absorption.10 These properties can make TheraCal an advantageous material in DPC.
There are very few studies done on primary molars evaluating the effectiveness and long-term results of different medicaments specially this newer material (TheraCal) for DPC. Therefore, the current study aimed to evaluate the clinical and radiographic success of direct pulp capping in primary molars with TheraCal, in comparison with MTA and calcium hydroxide.
MATERIALS AND METHODS
This randomized control study was conducted in the Department of Pedodontics and Preventive Dentistry, Rohtak. Children aged 5–8 years without any underlying systemic illness having asymptomatic carious primary molars in which pulp was exposed during caries excavation were included in the study. A tooth that was nonvital and positive for spontaneous pain, tender on percussion, and radiographically presenting with resorption, periodontal ligament (PDL) widening, and interradicular and furcal radiolucency were excluded. Ethical approval was taken from the Institutional Ethical Committee for Human Research prior to the commencement of research (PGIDS/IEC/2019/25).
Sample size calculation was done considering the previous study by Erfanparast et al. which assessed the success rate of DPC with MTA and TheraCal as 94.5 and 91.8%, respectively. A sample size of 24 in each group was calculated (α = 5% and power = 80%). Considering 20% of subjects lost to follow-up/attrition, the final sample of 90 carious teeth (30 per group) was taken. Around 90 primary molars were allocated randomly for DPC into three groups depending on the materials used for pulp capping (group I, TheraCal; group II, MTA; and group III, Dycal).
After obtaining informed consent from all the parents or legal guardians of the studied subjects. Local analgesia using 2% lidocaine with 0.005 mg epinephrine (local anesthetic (LOX) 2% adrenaline injection, Neon Laboratories Ltd) was administered followed by rubber dam isolation of the tooth. Enamel and peripheral caries were removed using no. 330 fissure diamond bur, in high-speed handpiece along with copious water coolant and using carbide round bur in slow speed handpiece dentinal caries were removed. Simultaneously, manual excavation of most carious tissue was done using an excavator. In between, the dentinal debris was washed away using 1% sodium hypochlorite irrigation. For a tooth that got pulpally exposed (<1 mm) during the procedure, hemostasis was tried to attain using a cotton pellet moisturized with normal saline and 0.12% chlorhexidine (chlorhexidine gluconate 0.12% oral rinse, periodic) on the exposure point with gentle pressure for about 2–3 minutes. If failed to obtain hemostasis the tooth was excluded from the study and pulpotomy or pulpectomy was done according to the degree of inflammation. A tooth with no signs of pulpal exposure was restored conventionally and was excluded from the study.
After hemostasis was established, the tooth was randomly allocated into groups following the lottery method of simple random sampling technique.
Direct pulp capping in this group was done with TheraCal LC (Bisco, United States of America), which was applied at a thickness of 1 mm over the exposed pulp using its syringe tip according to the manufacturer’s instructions. The peripheral margins were extended approximately 1 mm beyond the exposure site. The material was condensed using a conventional amalgam condenser followed by light-curing of the cement for the 20s (Being Tulip LED light-cure unit), after which the cavity was restored using glass ionomer cement (Ketac molar, 3M Espe).
Direct pulp capping in this group was done with MTA (Angelus). MTA manipulation with the distilled water was done according to the manufacturer’s instructions and was placed over the exposure site with an MTA carrier in a thickness of 1.5–2 mm and margins extending approximately 1 mm beyond the exposure site and condensed using an amalgam condenser. Since MTA needed time to set moist cotton pellet was placed over the MTA followed by temporary restoration (Orafil-G, Prevest DenPro) for 24 hours. The cavity was sealed using glass ionomer cement (Ketac molar, 3M Espe) on the next day.
Teeth in this group underwent DPC using a Dycal calcium hydroxide cavity liner (Dentsply Sirona). Calcium hydroxide paste (Dycal) was blended according to the manufacturer’s instructions and applied to the site of exposure using the ball-ended instrument. Excess cement from cavity walls was removed using an excavator followed by restoring the cavity using glass ionomer cement (Ketac Molar, 3M Espe).
The patient was assessed postoperatively and was recalled at 3, 6, and 9 months. On follow-up, patients were examined and evaluated clinically and radiographically for pain, swelling, sinus tract pathological mobility, tenderness on percussion, sensitivity to percussion, internal resorption, external resorption, periodontal ligament widening, interradicular radiolucency, periapical lesion, and recurrent caries. Tooth presenting any of the signs and symptoms mentioned in the above criteria at the time of follow-up was considered a failure. The entire clinical procedure was done by a single operator and follow-ups were performed by two experienced pediatric dentists, who were “blinded” to the applied material. The κ-agreement coefficient was used to evaluate interexaminer reliability at follow-up sessions.
All the data obtained from the study was compiled on a Microsoft Office Excel Sheet (version 2019, Microsoft Redmond Campus, Redmond, Washington, United States) and was put through statistical analysis using Statistical Package for the Social Sciences (SPSS version 26.0, IBM). The Chi-square test was used to compare the frequencies of categories of variables with groups and time. Intergroup comparisons were performed using a one-way analysis of variance followed by pairwise comparison using a post hoc test.
A total of 90 carious primary molars from children aged between 5 and 8 years fulfilling inclusion and exclusion criteria were taken in the study. Figure 1 shows the subjects throughout the study. The frequency of clinical and radiographic variables at the 3, 6, and 9 months follow-up have been shown in Tables 1 and 2.
|3 months||6 months||9 months||3 months||6 months||9 months||3 months||6 months||9 months|
|Pain + swelling + TOP + IRR||1||0||0||0||0||0||0||2||0|
|Pain + swelling + sinus + IRR||0||1||0||0||0||0||0||0||0|
|Pain + TOP||0||0||2||1||0||0||1||0||0|
|Pain + IRR||0||2||0||0||1||0||0||0||0|
|Pain + IRR||0||0||0||0||0||0||0||0||0|
|Pain + IR + ER + IRR||0||0||0||0||0||0||0||1||0|
|Pain + TOP + IRR||0||0||0||0||0||0||0||1||0|
|Pain + TOP + RC||0||0||0||0||0||0||0||0||1|
|Pain + swelling + sinus + IR + ER + IRR||0||0||0||0||0||0||0||1||0|
|Sinus + IRR||1||0||0||0||0||0||1||0||0|
|ER + IRR||0||0||0||2||0||0||0||0||0|
|Follow-up||3 months N = 30||6 months N = 30||9 months N = 30||3 months N = 30||6 months N = 29||9 months N = 29||3 months N = 28||6 months N = 28||9 months N = 27|
At 3 months follow-up, two teeth out of 30 in group I (TheraCal), four teeth out of 30 in group II (MTA), and four teeth out of 28 in group III (Dycal) failed according to the clinical and radiographic criteria. The success rate at the end of the 3-month follow-up in groups I, II, and III was 93.3, 86.66, and 85.71%, respectively. At 6 months, 28 teeth in group I, 26 teeth in group II, and 24 teeth in group III were followed. Amongst them, six cases in group I, three cases in group II, and six cases in group III showed clinical/radiographic failure. 10.71% of cases in group III showed internal resorption (Table 1). After excluding the failed cases total of 61 teeth were obtainable for the clinical and radiographic evaluation at 9 months.
Around 9 months of follow-up presented four, one, and four failed cases in groups I, II, and III, respectively. At the end of the study 18 teeth in group I, 22 teeth in group II, and 13 teeth in group III were left completely asymptomatic.
The study showed a gradual decrease in success rate from 93.3% (group I), 88.66% (group II), 85.71% (group III) at 3 months to 73.3% (group I), 75.86% (group II), 64.28% (group III) at 6 months which finally at the end of 9 months dropped out to 60, 72.41, and 48.14% in each group, respectively (Tables 2 and 3). Failure was observed in all three groups. Nevertheless, the response was comparably better with MTA compared to TheraCal and Dycal and both MTA and TheraCal were better than Dycal. However, the difference in the overall success rate between the groups at 9 months was statistically nonsignificant (p = 0.178) according to the Chi-squared test.
|Groups||3 months||6 months||9 months||p-value at the end of 9 months (Chi-square test)|
|TheraCal||28/30 (93.3%)||22/30 (73.3%)||18/30 (60%)||0.178 (p > 0.05) Statistically nonsignificant|
|MTA||26/30 (86.66%)||22/29 (75.86%)||21/29 (72.41%)|
|Dycal||24/28 (85.71%)||18/28 (64.28%)||13/27 (48.14%)|
Evidence from the previous literature suggests direct pulp capping in primary dentition to be a less successful treatment(Fuks and Rodd et al.).11,12 However, few recent studies have shown favorable outcomes of DPC in primary teeth (Tuna and Olmez, Ghajari et al., Asl Aminabadi et al., and Erfanparast et al.).2,5,9,13,14 Considering direct pulp capping as a minimally invasive, inexpensive, and simple procedure and to authenticate the previous results of DPC, the current study aimed to assess the clinical and radiographic efficacy of TheraCal in direct pulp capping in primary molars in comparison with MTA and calcium hydroxide. The present study showed nonsignificant (p = 0.178) difference between the groups with an overall success rate of 60, 72.41, and 48.14% in group I (TheraCal), group II (MTA), and group III (Dycal), respectively. However, various other factors influence the outcome of DPC which includes proper case selection and use of antimicrobial medicaments with acceptable seal (Asgary et al.).3 Response of exposed pulp varies in line with the etiologic factors (deep caries, trauma, or iatrogenic). Traumatic exposure to pulp has shown fewer inflammatory reactions and negligible pulpal changes in comparison with the cariously exposed pulp.15Table 4 represents recent studies done on direct pulp capping using different materials and their outcomes in primary dentition.9,13,16-23 Differences in the outcomes could be due to treatment modalities like study design, pulp capping material used, type of restoration used, the skill of the operators, site of exposure, and pulpal health before treatment. One of the key factors required for pulpal healing postexposure is the absenteeism of infection.24 Any remaining bacteria or leakage of new bacteria can cause failures. Histologic studies have shown decreased success after DPC due to chronic inflammation beneath cariously exposed pulp caps.25 In order to minimize the inclusion bias only those teeth with noncontaminated pulpal exposure of <1 mm and hemostasis achieved within 3 minutes were included in the study. To ensure infection control and to avoid the detrimental effect of saliva on exposed pulp and on restorative procedure all the procedures were carried out under proper rubber dam isolation.26 Regular disinfection of the exposure site was carried out using normal saline and chlorhexidine (0.12%) so that the cellular biology gets minimally altered.27
|Author/year||Study design||Total study subjects||Age-group||Inclusion standards||Method to control bleeding||DPC material used||Restorative material used||Study period/assessment||Outcomes of the study|
|Vafaei17 (2019)||Randomized split-mouth clinical trial||45 pts 90 teeth||5–7 yrs||Deep cavitated primary molars involving one-third and one-fourth of dentin without any signs of pulpal involvement||Cotton pellet soaked in sterile normal saline||MTA,Protooth (novel calcium silicate cement)||Conventional amalgam||12 months clinical/radiographic evaluation||90% success with MTA 85% success with protooth|
|Kotsanos18 (2014)||Prospective study||62||3–9 yrs||Asymptomatic deep cavitated primary molars||None||Calcium hydroxide||Either adhesive restoration or crown||4 years clinical/radiographic evaluative||80% survival rate|
|Songsiripradubboon19 (2015)||Randomized clinical trial||47||7–11 yrs||Deep carious lesion with sufficient coronal structure and without any signs and symptoms of irreversible pulpitis||Moist cotton pellet||Acemannan, calcium hydroxide||RMGIC + SSC||6 months clinical/ radiographic/ histopathological investigation||72.73% success with acemannan, 70% with calcium hydroxide, Acemannan treated group better histopathological response|
|Haghgoo R.20(2016)||Randomized clinical trial||7–8 yrs||Sound primary canine indicated for extraction||Saline moistened cotton pellet||MTA, Bioactive glass||Amalgam||Histopathological investigation||No internal resorption, abscess, dentin bridge formation in both the groups|
|Naser Asl Aminabadi21(2010)||Randomized clinical trial||120 (84pts)||4–5 yrs||Vital primary molars with deep caries||Sterile saline||Formocresol, Calcium hydroxide||SSC||2 yrs clinical/ radiographic evaluation||Clinical and radiographic success with formocresol 90% and 85% while with calcium hydroxide 61.7% and 53.3%|
|Bogen et al22(2008)||Observational study||53 teeth||7–45 yrs||Teeth with reversible pulpitis||Cotton pellet soaked in 5.25 sodium hypochlorite||MTA||Unbonded clearfil photocore||Clinical, radiographic, histological evaluation||Favorable radiographic appearance, cold test response, no subjective symptoms, and successful apexogenesis|
|D. Tuna9(2008)||Randomized clinical trial||50 teeth||5–8 yrs||Primary molars with deep occlusal caries||Moist cotton pellet||MTA, Calcium hydroxide||Amalgam||24 months, clinical and radiographic evaluation||No clinical/radiographic failure in both the groups|
|Ghajari MF13 (2010)||Randomized clinical trial||42 teeth||5–8 yrs||Carious primary tooth with vital pulp with at least 2/3rd of root length||Wet cotton pellet||Calcium-enriched matrix(CEM), MTA||Amalgam||6 months, clinical and radiographic evaluation||94.8% and 100% clinical success rate in CEM and MTA respectively with no radiographic failure|
|Aminabadi NA23 (2013)||Randomized clinical trial||120 teeth||7–9 yrs||Primary molars planned for extraction for orthodontic treatment||–||Calcium hydroxide, Simvastatin (conc. 1,5,10µM)||ZOE + SSC||7.4 months, histological investigation||Dentin bridge formation 55%, 20%, 7% and 0% in calcium hydroxide, simvastatin 1 µM, simvastatin 5 µM, simvastatin 10 µM respectively|
|H. Ali24(2021)||Randomised double-blind, parallel, two-arm control trial||120 teeth||5–11 yrs||Restorable vital primary molars with deep carious lesions||–||3Mix-MP, Calcium hydroxide||Composite resin||1 year, clinical radiographic assessment||54.5% success with 3Mix-MP, 77.3% with calcium hydroxide|
In the present study children aged 5–8 years were taken as the physiological resorption of deciduous molars usually begins after the age of 7–8 years. Haskell et al. and Baume and Holz in their clinical studies suggested that age made no difference in the success rate of direct pulp capping.28,29 On the contrary, few studies recommend considering age before performing vital pulp therapy because of the better healing potential of pulp in young patients. However, it is still a controversial topic in the literature that requires further research.30 The critical period for evaluation of the success or failure of pulp capping in human subjects is between 6 and 12 months after the procedure.31 In this study, subjects were followed at 3, 6, and 9 months intervals. However, a longer follow-up may influence the long-term success rate.
In the present study, more failures were observed in group III (Dycal). Among the clinical and radiographic evaluation criteria, pain was the most frequent reason for failure at the follow-up. The pain was maximum in group III followed by group I and least in group II. However, it was not statistically significant (p > 0.05). It was observed that in the long-term, the success outcome of calcium hydroxide decreased drastically as a liner/capping agent, this can be due to the microfissures formed between the material and dentinal floor creating an outward hydraulic pressure leading to exudation of pulpal fluids, dissolution of calcium hydroxide, and eventually resulting in bacterial invasion and pulpal inflammation.32 Previous studies confirm that direct pulp capping using calcium hydroxide showed lower success rates with longer follow-up periods. Barthel et al. 2000, in their retrospective study, reported 37 and 13% success rates of DPC using calcium hydroxide at 5 and 10 years.33 In this study success rate at the end of 9 months in calcium hydroxide (group III) was 48.14%. Under radiographic outcomes, interradicular radiolucency was seen the most, in all the groups being maximum in group III. In the previous study, root resorption was the most common pathologic finding in response to pulp therapy.20 Three cases (10.71%) in group III showed internal resorption at 6 months, suggesting odontoclast-mediated internal resorption with calcium hydroxide. However, studies that have used materials other than calcium hydroxide have shown none of failure due to internal resorption.2,13 Groups I and II in this study showed no associated internal resorption, supporting the fact that MTA/TheraCal (calcium silicate-based cements) shift the status of pulp from inflammatory to reparative one.34
Group I (TheraCal) showed an overall success of 60% at the end of 9 months. Comparable results were seen in a randomized clinical trial, where 66.6% success was found with TheraCal in DPC.35 In contrast, another study showed the considerably greater success of direct pulp capping in primary molars using TheraCal (91.8%) and MTA (94.5%).2 Limited success in the TheraCal group could be because of restricted access to the curing light leading to a reduced degree of polymerization and a rise in the level of uncured monomer, which eventually lowers the cement biocompatibility. Other possible explanations for the limited success of TheraCal could be its external chemical nanoshell surface which could mask the calcium ion release from these materials.2 Further investigations are needed to analyze the effect and influence of free monomers on TheraCal biocompatibility.
Among the three groups in this study, MTA comparatively had better outcomes, with an overall success rate of 72.41% at the end of this study. The larger success rate of 91.3% in DPC with MTA was reported by Marques et al.36 The higher success rate of MTA in comparison with TheraCal and calcium hydroxide in this study could be attributed to its antibacterial property and formation of the apatite-like layer which increases the sealing ability of MTA.16 Suhag et al. in the year 2019 performed a similar study comparing calcium hydroxide and MTA in direct pulp capping in permanent teeth. In their study, the maximum failure was in the calcium hydroxide group and the least was with MTA.31 Another critical element for the success of direct pulp capping is the quality of coronal restoration. In the study, GIC was used for restoring the tooth. Better results could have been obtained if the crown was placed as a permanent restoration. In group II (MTA) permanent restoration was done after 24 hours, which might have interfered with the success of MTA in DPC as bacterial leakage through the temporary filling is considered deleterious to treatment outcome in pulp capping procedures.35
Though the study was performed under rigid inclusion criteria, randomization, and absolutely aseptic conditions the combined success rate of direct pulp capping was found to be 60.46%. This study clinically and radiographically showed limited and poor prognosis of DPC for cariously exposed primary teeth. However, histological examination is considered to be the gold standard for determining the outcomes of vital pulp therapy.37 Since this was a clinical study, histologic investigation herein could not be performed. Hence, we cannot draw a definitive conclusion in favor of DPC in primary teeth solely on the basis of clinical and radiographic criteria.
With the continued advancement and availability of bioactive pulp medicaments further studies using different newer materials with histological investigation, larger sample size, and longer follow-up period are needed to confirm the exact status of the pulp and dentin bridge thickness after DPC.
Within the constraints of this study, it can be inferred that direct pulp capping in primary molars has limited success and unfavorable outcomes. Among the three pulp-capping medicaments used in the current study, MTA had better performance in comparison to TheraCal and calcium hydroxide (Dycal). However, the difference was statistically nonsignificant (p > 0.05).
Ruchi Singhal https://orcid.org/0000-0002-5514-2482
Parul Singhal https://orcid.org/0000-0002-6313-5522
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