Comparison of the Conventional Band and Loop Space Maintainers with Modified Space Maintainers: A Split-mouth Randomized Clinical Trial

Introduction

The importance of primary dentition for a child’s growth and development along with the guidance and eruption of permanent teeth is well documented in the literature. Midline shift, space loss, impacted or ectopic eruption of a permanent successor, crowding, etc., are some of the unfavorable sequelae of premature loss of primary teeth. Hence, the space created by premature loss of primary tooth needs to be preserved to maintain the integrity of dentition till the eruption of their permanent successor. Therefore, maintaining space during the period of primary and mixed dentition is important for masticatory efficiency, proper space for successors to erupt, and to maintain the vertical dimension.

Space maintainers (SMs) are the appliances used for maintaining the space left by the loss of primary incisors, primary canines, and primary molars. These can be classified as, removable or fixed, active or passive, functional or non-functional, and unilateral or bilateral. Amongst various non-functional SMs, band and loop (BandL) SM is one of the most frequently used appliances with a high success rate. However, BandL SMs have several disadvantages too; they require impression making, tedious laboratory work, multi-visit procedure; dislodgement due to decementation of bands, cervical caries formation, slippage of the loop, and tipping of abutment teeth and often may be a source of metal allergy. Thus, to overcome these disadvantages of BandL SM, tube and loop (TandL) SMs were introduced. The design of the TandL SM is simple, quick, and easy and can also act as a space regainer. It is a single sitting procedure that does not require any laboratory work, thus, offers more advantages over the conventional BandL SMs. However, to overcome the disadvantages of banded SMs, attempts have been made to utilize newer materials in SMs’ fabrication which omit/avoids band adaptation. Bonded SMs do not require impression making and band adaptation thus, they can be done in a single sitting and there is minimal or no discomfort to the patient. Also, in bonded BandL SMs, loop is bonded to the smooth surfaces of the teeth (buccal and palatal/lingual) with the help of composite resin. Whereas, in the bonded tube and loop (BTL) SMs, molar tubes are bonded to the buccal surface of the teeth with the help of composite resin, and a loop is inserted in them.

Due to scanty literature, there has been little comparative clinical evaluation on the comparison of banded vs bonded SMs currently available. Therefore, this study aimed to compare the efficacy of conventional BandL with conventional tube and loop (CTL), BTL and bonded loop (BL) SM in terms of gingival health, survival time and patients’ and parents’ satisfaction.

MATERIALS AND METHODS

A total of 15 otherwise healthy children, aged 4–9 years with grossly mutilated single molars on either side, requiring extraction or freshly extracted single molars bilaterally in the same arch or opposite arch were selected from the Outpatient Department of Pediatric and Preventive Dentistry. Ethical clearance was obtained before the study. Informed consent was obtained from parents/guardians of the children participating in the study.

RESULTS

The survival time of different SMs (BandL, BL, BTL, CTL) at different follow-up intervals (0, 1, 3, 6, 9 months) was observed (Table 1). On follow-up of 1-month, all the SMs in all the groups survived successfully. At a 3-month interval, 1 BL SM failed due to bond failure while all the remaining SM survived. At a 6-month interval, 1 case of BTL SM did not report while all the remaining SM survived. At the 9-month interval, 1 more BL SM failed due to bond failure while all the remaining SM survived. The difference between the survival rate at 3, 6, and 9 months was statistically non-significant (p > 0.05) (Fig. 1).

The comparison of gingival health of the abutment tooth using gingival index (by Loe and Silness) in all the groups at a different time interval (0, 1, 3, 6, 9 months) showed that there was mild gingivitis (0.1–1.0) in all the cases till 1st month. However, the group with BL exhibited moderate (1.1–2.0) gingivitis starting from 3rd month onward (Table 2 and Fig. 2).

Intergroup comparison of parents’/patients’ acceptance (Table 3) for all the groups at a different time interval (0, 1, 3, 6, 9 months) showed that for the total 9-month follow-up, the mean of patients’/parents’ perception was found to be statistically significant (p %3C; 0.05) between group I, II, and III (Fig. 3).

DISCUSSION

The BandL SMs are the most common, however, to overcome their disadvantages, TandL SMs were introduced. The TandL is simple, quick, easy, and can also act as a space regainer. It is a single sitting procedure that does not require any laboratory work, thus, offers more advantages over the conventional BandL SMs. Another advantage of this SM is that the loop can easily be rotated up for routine cleaning of the area, adjusted/activated by coiling or uncoiling the helix, and can be removed if required, without disturbing the bands. ³

But because of the various disadvantages associated with the banded type of SMs, attempts have been made to utilize newer materials in SM’s fabrication which omit/avoids band adaptation. Thus, bonded SMs were introduced which do not require impression making and band adaptation and can be done in a single sitting with minimal or no discomfort to the patient.

In the present study, in group I and group II, the survival time was 100% (n = 5) for BandL SMs whereas 60% (n = 3) and 80% (n = 4) for BL and BTL SMs, respectively, till 9-month follow-up. The reason for failure in bonded SM was because of debonding of the composite that could be attributed to inadequate moisture control, the morphology of the tooth and chemical composition of the material used to bond the appliance, the arch in which SMs were given, and the abutment tooth (primary or permanent tooth) being bonded. ⁴

Also, the bond strength of primary tooth enamel is considerably lower than the permanent tooth enamel due to the presence of prismless zones in the enamel of primary teeth, which tend to have an adverse effect on the bond strength thereby, affecting resin retention. ⁵ Occlusal trauma might be also one of the causes in cases of newly erupted teeth where the area available for bonding is inadequate. ^6–9

In the present study, oral health was evaluated in terms of gingival health using the gingival index which is a simple, accurate method in epidemiological and clinical research. ^10–13 In group I, for a follow-up of 1st month, there was mild gingivitis (0.1–1.0) in both the cases. However, the group with BL exhibited moderate (1.1–2.0) gingivitis starting from the 3rd month onward whereas the group with BL remained mild. Thus, among both the SMs (BandL, BL), BL SMs had good gingival health till the 9-month follow-up. The reason for moderate gingivitis could be attributed to some unpolished margins that might have been left in the bands after festooning and trimming and these unpolished margins had become a source for bacteria to harbor and grow for a 9-month long interval. Thus, causing moderate gingivitis. ^14–16

In group II, BandL exhibited moderate gingivitis (mean–1.20) starting from 3 months onward up to 9 months whereas the group with BTL exhibited mild gingivitis (mean–0.40) at 3- and 9-month follow-up. Therefore, it can be stated that among both the SMs (BandL, BTL), BTL SMs exhibited good gingival health till the 9-month follow-up.

Mild gingivitis present in the bonded SMs could be attributed to the fact that composite is not “gingiva friendly” and its unpolished surfaces attract plaque accumulation. ¹¹

In group III, BandL exhibited moderate gingivitis (mean–1.20) starting from the 3rd month onward whereas the group with CTL remained mild (mean–0.80). Thus, when BandL and CTL were compared, CTL proved to be superior in terms of gingival health. As CTL had a more hygienic design as compared to BL, because of the presence of a freely movable loop in CTL.

Though oral hygiene instructions were given to all the patients, still, the area around the appliance was not clean, as a result, gingivitis was seen. The findings of the present study emphasize the importance of maintaining good oral hygiene and plaque control during SM treatment. According to Subramaniam et al. bonded SMs are likely to permit better oral hygiene maintenance, because of no injury to the gingival tissue. ⁹

In the present study, patients’ and parents’ satisfaction was assessed in the groups using the Likert 5-point scale because of its adequate reliability and validity. ²

In group I and II, patients’ and parents’ satisfaction were more toward bonded SMs. A highly significant difference was found between BandL–BL and BandL–BTL in terms of patients’ acceptance. The reason could be attributed to the fact that there was no Impression making and band adaptation and the whole procedure could be completed in a single sitting which caused minimal or little discomfort to the patient.

In group III, for patients’ and parents’ satisfaction, when BandL SM was compared with CTL SM, the mean of patient’s and parents’ satisfaction at 0th and 1st month were found to be statistically non-significant. However, the mean of patients’/parents’ perception at 3rd, 6th, and 9th months were statistically significant (p < 0.05). Thus, suggesting patients’ and parents’ satisfaction was significantly higher in the CTL group when compared with the BL group as it is a single visit procedure, economical, no requirement of impression, and a freely movable loop which attributed to good hygiene.

According to Deshpande et al., the appropriate design and fabrication, meticulous oral hygiene maintenance, and regular follow-ups would certainly make bonded SMs a viable alternative to the conventional banded appliances. ¹⁰

CONCLUSION

Based on the results of the study, the following conclusions were drawn:

• All the SMs proved to be clinically successful in terms of survival time, gingival health, and patients’ and parents’ satisfaction.
• 100% of the CTL and BandL survived till 9 months. The success rate of the BTL SMs was 80% whereas only 60% of the bonded BandL SMs survived till the end of the study.
• Though, none of the SMs were found to be absolutely gingival friendly, CTL SM showed the best results in terms of gingival health. Whereas, BandL SM showed the worst results.
• Both patients and parents were totally satisfied with the bonded (BTL and BL) SMs.
• Upon evaluating all the parameters, the efficacy of different types of SMs can be summarized as CTL %3E; BandL > BTL > BL.

However, further studies are needed to be conducted on larger sample size and with long-term follow-up to evaluate the efficacy of these SMs in terms of survival time, gingival health, and patients’ and parent’s satisfaction.

Clinical Significance

To find a better alternative to conventional SMs which requires less patients’ compliance.

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