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ORIGINAL ARTICLE
Year : 2022  |  Volume : 40  |  Issue : 3  |  Page : 281-287
 

Evaluation and comparison of silorane resin composite to glass ionomer in occluso-proximal restorations of primary molars: A randomized controlled trial


1 Navneet Jain Health Centre SMBT Dental College, Hospital and Research Center, Sangamner, Maharashtra, India
2 Former Intern, Government Dental College and Hospital, Mumbai, Maharashtra, India
3 Department of Public Health Dentistry, SMBT Dental College, Hospital and Research Center, Sangamner, Maharashtra, India

Date of Submission01-Sep-2022
Date of Decision12-Sep-2022
Date of Acceptance13-Sep-2022
Date of Web Publication18-Oct-2022

Correspondence Address:
Viral P Maru
Navneet Jain Health Centre, Mumbai, Maharashtra
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/jisppd.jisppd_377_22

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   Abstract 


Objective: In general, proximal restorations of primary molars fracture, so it is vital to study the new materials that could solve this problem. Hence, the present trial assessed the success of occluso-proximal atraumatic restorative treatment (ART) restorations using silorane and glass ionomer cement (GIC) in carious primary molars for a period of 2 years. Materials and Methods: One hundred and ninety-two children between the age group of 4 and 9 years were randomly allocated to GIC or silorane. In the clinical set up, they were treated by a pediatric dentist, and their restorations were evaluated at 3, 6, 12, 18, and 24 months. The primary outcome was the survival of restoration, which was analyzed using the Kaplan–Meier and superior Cox regression models. As a sensitivity analysis, intention-to-treat (ITT) was executed. Sex, age, molar, jaw, cavity volume, and caries incidence were the independent variables. Results: The restoration survival after 24 months for GIC and silorane was 82.75% and 88.88%, respectively, whereas ITT analysis showed a success of 84.37% and 89.58% for GIC and silorane, respectively. Conclusion: With regard to longevity, there was no statistically significant difference between silorane and GIC in primary molar occlusoproximal ART restorations.


Keywords: Glass ionomer cement, proximal carious primary molar, silorane, survival success


How to cite this article:
Maru VP, Kulkarni P, Chauhan R, Bapat SS. Evaluation and comparison of silorane resin composite to glass ionomer in occluso-proximal restorations of primary molars: A randomized controlled trial. J Indian Soc Pedod Prev Dent 2022;40:281-7

How to cite this URL:
Maru VP, Kulkarni P, Chauhan R, Bapat SS. Evaluation and comparison of silorane resin composite to glass ionomer in occluso-proximal restorations of primary molars: A randomized controlled trial. J Indian Soc Pedod Prev Dent [serial online] 2022 [cited 2022 Nov 29];40:281-7. Available from: http://www.jisppd.com/text.asp?2022/40/3/281/358839





   Introduction Top


In India, a significant need for dental rehabilitation exists for children, with slightly more than half suffering from unrestored dental decay in the primary teeth.[1] The most frequently utilized management for carious lesions is definitive restorative treatment, which entails rotary device removal of carious dentin and restoring cavity with composite resins.[2] Restorations like these are extremely beneficial to pediatric patients and their loved ones.[3],[4] However, it has been shown that using rotating devices and local anesthesia during clinical procedures generates unpleasant feelings and affects behavior, resulting in increased anxiety and apprehension during subsequent dental visits.[5],[6]

Minimally invasive dentistry that emphasizes atraumatic restorative treatment (ART) should be the recommended treatment for treating dental decay in the primary teeth, thereby decreasing the downward restorative cycle and alleviating patient discomfort during treatment.[7],[8] When compared to traditional treatment, ART has been widely used in pediatric dentistry since it is related to decreased anxiety, suffering, and distress, as well as increased acceptance by pediatric patients.[9],[10],[11] Single-surface cavities have a long survival rate in both the primary and permanent dentitions.[12],[13],[14],[15] ART, on the other hand, has exhibited poorer survival rates when used to restore cavities involving multiple surfaces, ranging from 93% to 12.2% after 3 years.[12],[13],[16] Thus, the hunt for another adhesive restorative material capable of improving the success of occluso-proximal restoration continues.

Filtek P90 (3M, USA) is a unique class of resin matrix based on ring-opening monomers for dental composites. This hydrophobic composite is made up of a siloxane and oxirane polymer mixture. The primary advantage of this novel restorative material is its low shrinkage and equivalent mechanical qualities to methacrylate-based composite material.[17],[18] As a result, the current study aimed to assess the durability of occluso-proximal ART restorations using Filtek P90 (3M, USA) and glass ionomer cement (GIC) (Equia Forte® – GC Corp) in carious primary molars after 24 months.


   Materials and Methods Top


The CONSORT Statement for the Reporting of Randomized Clinical Studies was followed in the present parallel-group, randomized controlled trial.[19] The sample size was computed with an α =5%, power = 80%, a superiority margin of 20%, and added 15% of the probable loss to recall visits,[20] which led to the final sample size of 176 teeth. The present experiment enrolled 192 children aged 4–9 years who presented to the department of dentistry at Navneet Health Center in Mumbai with minimum of a one occluso-proximal dental decay in a primary molar. When a kid had more than one possible tooth for restoration, we performed a simple lottery to determine which one would be included in our trial on the day of therapy. The caregivers completed a consent form authorizing their ward's inclusion in the investigation. The present trial was approved by the institution's ethical board.

Any primary molar with an occluso-proximal carious lesion that could be accessed with hand instruments met the inclusion criteria. Children who had disruptive behavior during the initial assessment, had signs or symptoms of pulpitis, spontaneous and throbbing pain, and/or dentoalveolar abscess/sinus around the concerned molar, or whose caretakers refused to participate were excluded. To secure the concealing of the allocation, we employed sealed envelopes. The envelopes were opened by an independent dental assistant from the hospital only when the cavity was ready for restoration. It was impossible to blind the operator, participant, or evaluator in this investigation because of the obvious visual distinctions between the restorative dental cements used and the therapeutic processes involved. A pediatric dentist trained in ART restorations served as the study's sole operator and completed all restorations.

Gender, age, primary molar, arch type, cavity volume, and caries status were included as the independent variables in this study. When the child was brought in for treatment, their full name, sex, and birth date were noted. The pediatric patient then sat on the dental chair while the operator determined if one or more primary carious molars was suitable for restoration (and asked for the lottery as and when needed). Later, the jaw (maxilla/mandible) and primary carious molar (first/second) were recorded. The World Health Organization (WHO) criteria were used to evaluate the caries status.[21] We recorded decayed missing and filled permanent teeth (DMFT) and decayed, missing, and filled primary teeth (dmft).[22] Three measurements with a WHO probe were taken to determine the volume of the cavity (buccal-palatal, mesial-distal, buccal-lingual, or occlusal-cervical). Due to the asymmetry of the cavity, the volume obtained was not accurate. The objective was to assess the volume to ascertain whether it would affect the restoration's survival rate.

All pediatric patients were treated as per the Frencken and Holmgren ART protocol.[23] Without local anesthesia, the operator used hand instruments to remove soft and infected carious dentin.[24] In both groups, cotton rolls were employed to isolate the teeth. When spoon excavators could not reach lesions, an enamel hatchet was used to open the enamel. Once the cavity was prepared, the operator recorded the cavity's volume (mm3) and then opened the randomization letter sealed in an envelope to reveal the restorative dental cement to be used.

Control group: GIC - Equia Forte [Supplementary Table 1].



After removing carious tissue, the conditioner (GC Corporation, Japan) was applied for 15 s using a micro applicator. Cotton pellets were used to dry the cavity after rinsing. To restore the proximal surface a wedge and matrix band were used. After opening the capsule, GIC was mixed for 10 s. The cavity was restored with the same through an applicator. Since it cures chemically, it can be applied in bulk. Finally, the restoration was coated with a very thin film of Equia Forte Coat® light cured for 20 s using a micro applicator. An articulating paper was used to confirm the absence of any occlusal discrepancy. If adjustments were required, we employed an excavator and reapplied the coating.[25] Pediatric patients were instructed to avoid chewing food for the next 60 min postoperatively.

  • Experimental Group: Filtek P90 (3M)


  • Following the removal of carious tissue, the walls of the prepared cavity were cleaned by brushing a damp cotton pellet to get rid of contaminants. A wedge and a matrix band were introduced to re-establish the proximal contour. Using a micro applicator, a thin coat of self-etch primer was applied and was cured for 15 s. The operator restored the entire cavity in one or two increments and then cured each increment surface for 20 s.[26] An articulation paper was employed to see if there was any interference. A scalpel blade was used to make any adjustments that were required.

  • Evaluation:


The study's main outcome was the restoration's survivability. The Roeleveld et al [Supplementary Table 2].[27] criteria were used to evaluate restorations by a skilled and calibrated dentist. An expert trained the assessor for 7 days on clinical and laboratory operations. Following this training, the investigator examined restorations in 25 paediatric patients who were not enrolled in the trial, then repeated the assessments 1 week later to determine intra-investigator consistency. A reference examiner reviewed the same 25 restorations to establish consistency between examiners. Before each assessment, the examiner was re-calibrated. Before each assessment, the examiner was re-calibrated. Only restorations that did not require any repairs (scores 00 and 10) were judged successful.[27]



Clinical evaluations were conducted after 3, 6, 12, 18, and 24 months of follow-up. A WHO probe was used to detect the depth and width of marginal disintegration, surface wear, material deficiency, and excess material.

Statistical analysis

Cox regression and a two-sample superiority test were used to examine the primary outcome (restoration survival). The P value and confidence interval for Miettinen and Nurminen's superiority test were used to calculate the percentage of treatment outcome at 24 months.[28] NCSS statistical software was used for analyses (USA).

A two-tailed Cox regression analysis was used as secondary research to evaluate the correlation between the predictive factors for failed restoration. In the univariate data analysis, factors with a P = 0.20 were included in the adjusted evaluation. The Kaplan–Meier survival and the Logrank test were used to determine overall restoration survival (α =5%). All evaluations were set at 5% significance.


   Results Top


The trial involved 192 children, with a mean age of 6.89 ± 1.56 years, ranging from 4 to 9 years. The restorations were placed in January 2018, and the evaluations were performed between May 2018 and January 2020. The weighted Kappa value for inter-examiner reproducibility (between the evaluator and an expert) was 0.78, and the intra-examiner agreement was 0.82. The survival analysis included every child who had been evaluated at least once throughout the follow-up period. The subject's flow since enrolment and the losses to follow-up in each evaluation are shown in [Figure 1]. The 15 participants who missed the 24-month evaluation were added using multiple imputations for the intention-to-treat (ITT) analysis.
Figure 1: Progress of pediatric patients through 24 months recall visit

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[Table 1] displays the baseline distribution of the variables and the Chi-square assessment between groups. The Chi-square test did not show a statistical difference in the distribution of the baseline characteristics evaluated (age, caries experience, jaw, molar, and gender) except for the volume of cavity (P = 0.021) among the restorative materials tested. [Table 2] presents the primary outcome analysis utilizing superiority Cox regression and ITT analysis. The survival rate of each group was GIC-75.0% and Silorane-83.3% after 24 months [Table 2] and [Figure 2]. Log rank test did not find a statistical difference between the restorative materials after 2 years (P = 0.239).
Table 1: Baseline distribution of variables between restorative materials and Chi-square analysis

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Table 2: Primary outcome analysis (restoration treatment survival) using superiority Cox regression and intention-to-treat analyses

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Figure 2: Kaplan–Meier survival estimates

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After 24 months, the GIC and siloxane groups had success rates of 82.8% and 88.9%, according to the ITT analysis. An absolute difference of 6.1% was discovered; however, no superiority was demonstrated (relative risk – 0.95). Except for age (P = 0.005) and volume of cavity (P < 0.001), the other variables appraised (restorative material, caries experience, and jaw) did not influence the survival of the restorations [Table 3].
Table 3: Univariate and adjusted Cox regression analysis (two-tailed) between treatment failure and prognostic factors after 24 months

Click here to view


The distribution of restorations failure scores for each group, according to Roeleveld et al.[27] criteria was as follows – score “11” for 10 GIC and 6 silorane restorations, score “12” for 6 GIC and 5 silorane restorations, score “20” for 4 GIC and 3 silorane restorations and score “21” for 4 GIC and 2 silorane restorations. From 18 to 24 months of follow-up, there has been a statistically significant increase in the failure rates of both the GIC and the silorane group [Figure 2]. The reason for this outcome could be the bulk fracture followed by secondary caries over a period of time. However, no statistically significant difference was identified between the groups regarding restoration success (P > 0.05).


   Discussion Top


We performed the current study because resin composites have better mechanical properties than glass ionomers, such as wear resistance and compressive strength, as well as the benefits of Silorane technology.[29] We also felt that the siolrane-based cement could minimize caries-related restorative failures. Our study demonstrated no measurable difference in survival time between silorane and GIC for occluso-proximal ART fillings in primary molars after 24 months. The GIC's survival rate of 24 months of the present study was close to the average survival rate of multiple surface fillings documented in de Amorim RG's literature assessment.[13] As predicted, both restorative groups survival percentage remained low compared to one tooth surface ART after 1 year, which were also presented in the same review (93%).[13] Higher than average failure rates may be due more to the cavity type than to the technique or material employed in occluso-proximal reconstructions.[12],[13] When dealing with primary molars with significant decay, stainless steel crowns currently have the best success rate.[30] Some countries, however, may not have them. More human clinical trials with adhesive cements are needed to improve overall survival in proximal cavities.

Including noncompliance subjects in the test increases the validity and reliability of the findings when using ITT analysis as the conventional diagnostic analytic approach for reporting an in vivo investigation. It was therefore decided to perform an ITT analysis to assess the success ratio of 2-year restorations, but Miettinen and Nurminen's criteria failed to indicate Silorane's superiority over GIC. The present study reports that bulk fracture of the restoration was the most common cause of failure, followed by secondary caries. This observation reinforces the findings of a systematic research on the causes of unsuccessful primary molar restorations.[30]

We selected a self-etch adhesive system (one step) as the procedures were completed in accordance with ART protocol, which precludes the use of the triple syringe or saliva suction for etchant rinse. However, research indicates that this self-etch adhesive system may be inadequate for primary dentition, perhaps resulting in restorative failure in both groups. This finding may account for silorane's slightly superior performance with respect to restorative failure in the current trial. Further investigations are required to explore siolrane's efficiency in primary teeth.

The present research's findings corroborated Poureslami's in vitro trial, which revealed that a better marginal seal could be established using etch + Filtek Silorane in primary canines.[31] Burke et al. studied the clinical outcome of Filtek silorane restorations in a clinical oriented cohort trial. Due to lowered polymerisation shrinkage, a study of silorane restorations (30 occlusal and 70 proximal restorations with 2-year follow-up) demonstrated good survival rates without any sensitivity problems after treatment.[32] Mahmoud et al.[33] found no statistically significant difference in the overall therapeutic benefit of silorane composite against methacrylate-based resin in proximal restorations during a 3-year prospective controlled randomized experiment. Goncalves and team found no substantial difference in treatment outcomes between hundred proximal cavities treated with Filtek P90 and those repaired with Filtek P60 over a 6-month period.[34]

To our knowledge, this is the first randomized study using ART to evaluate a bulk-fill Silorane composite as restorative cement for primary dentition. Restorative operations on molar teeth can be completed more quickly with these composites because of their increased cure depth and reduced polymerization shrinkage.[35] This fact may also have helped contribute to silorane's success in the current trial. The trial's primary constraint was the trial's restricted moisture control. Rubber dam isolation was not a choice because our goal was to treat pediatric patients using an ART guideline. The loss of follow-up is a frequent occurrence in the longitudinal research. Although we did not communicate directly with the caregivers of the pediatric patients in this trial, the loss to recall was minimal in all follow-up evaluations.

Another restriction was blinding. A favored operational safety approach for reducing bias in clinical trials is to blind the responders, the operators, and the outcome evaluators, thus boosting the accuracy of the data. Respondents, operators, and result assessors could not be blinded to the test and control groups because of the visual character of restorative cements studied and the wide range of recommendations used in our trial. When blinding is difficult due to logistical constraints, it is advised that investigators disclose this limitation and treat the assigned groups equally, as was done in the current experiment.[36],[37]

The concealment of the allocation was achieved using enclosed envelopes that were opened once the cavity preparation was completed. To eliminate the bias related to allocation, the randomized list and envelope arrangement were completed by an investigator's colleague who was absent during the treatment sessions. [Table 3] demonstrates a consistent distribution of baseline features across groups and a Chi-square test indicating that the gathered variables do not differ. This demonstrates the randomization process's validity.


   Conclusion Top


Consequently, within the limits of this investigation, our findings imply that employing silorane rather than GIC for enhancing the durability of occluso-proximal ART fillings does not provide any further benefit in primary molars. For these findings to be confirmed, additional clinical investigations are required.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
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    Figures

  [Figure 1], [Figure 2]
 
 
    Tables

  [Table 1], [Table 2], [Table 3]



 

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