Trial reportBMC oral health2022
Use of rubber dam versus cotton roll isolation on composite resin restorations' survival in primary molars: 2-year results from a non-inferiority clinical trial.
Trial report in BMC oral health, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 12 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
CARies DEtection in Children 03 - The Impact of Two Different Clinical Criteria for the Evaluation of Caries Lesions Around Restorations in Primary Teeth
Does the Isolation of the Operative Field Influence the Survival Rate of Bulkfill Composite Restorations in Primary Teeth
Who cites it
12 citing papers in PubMed, 1 synthesis or guideline pooled it, 18 citations in OpenAlex.
- Reducing pain and discomfort associated with rubber dam clamp placement in children and adolescents: a systematic review and meta-analysis of effectiveness.BMC oral health · 2023Pooled it
- The use of rubber dam in the survival of RMGIC restorations in primary molars: a 30-month randomized controlled clinical trial.Brazilian oral research · 2024Trial
- Patient Comfort and Acceptance of Different Isolation Techniques for Silver Diamine Fluoride Application: A Randomized Clinical Trial.International journal of clinical pediatric dentistry · 2026Article
- Optimizing Pediatric Patient Comfort: A Study of Moisture Isolation Techniques During Dental Treatments.Children (Basel, Switzerland) · 2026Article
- Minimally Invasive Ceramic Laminate Veneers for Maxillary Anterior Esthetic Rehabilitation: A 12+ Years Follow-Up.Journal of esthetic and restorative dentistry : official publication of the American Academy of Esthetic Dentistry ... [et al.] · 2025Article
- Clinical Performance of Bulk-Fill Versus Incremental Composite Restorations in Primary Teeth: A Systematic Review of In Vivo Evidence.Dentistry journal · 2025Review
- Clinical Difficulties Related to Direct Composite Restorations: A Multinational Survey.International dental journal · 2025Article
- Comparison of the 2-year clinical performances of class II restorations using different restorative materials.Clinical oral investigations · 2025Article
- Marginal Quality and Wear of Bulk-Fill Composites: Differences Between Dentitions.The journal of adhesive dentistry · 2025Article
- Article
- Current trends in placing posterior composite restorations: Perspectives from Palestinian general dentists: A questionnair study.Journal of International Society of Preventive & Community DentistryArticle
- Patient and Operator Experiences with Conventional Rubber Dam and OptiDam: A Randomized Clinical Trial.Journal of International Society of Preventive & Community DentistryArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors at 6 institutions in 4 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThis non-inferiority randomised clinical trial aimed to evaluate the survival of direct bulk fill composite resin restorations in primary molars using different methods of moisture control: rubber dam isolation (RDI-local anaesthesia and rubber dam) and cotton roll isolation (CRI-cotton roll and saliva ejector). Secondary outcomes included baseline and 2-year incremental cost, self-reported child's pain scores and patient behaviour during the restorative procedure.
methodsA total of 174 molars (93 children) with dentine caries lesions were randomly allocated to study groups (RDI or CRI) and restored with bulk fill composite resin by trained operators. Two blinded examiners assessed the restorations for up to 24 months. Wong-baker faces and Frankl's behaviour rating scales were used for accessing the child's pain and behaviour, respectively. The primary outcome (restoration survival) was analysed using the two-sample non-inferiority test for survival data using Cox Regression (non-inferiority/alternative hypothesis HR > 0.85; CI = 90%). Bootstrap Linear regression was used for cost analysis and logistic regression for pain and behaviour analysis (α = 5%).
resultsAfter 2-years, 157 restorations were evaluated (drop-out = 9.7%). The survival rate was RDI = 60.4% and CRI = 54.3%. The non-inferiority hypothesis was accepted by the Cox Regression analysis (HR = 1.33; 90% CI 0.88-1.99; p = 0.036). RDI was 53% more expensive when compared to the CRI group. No differences were found between the groups regarding pain (p = 0.073) and behaviour (p = 0.788).
conclusionCotton roll isolation proved to be non-inferior when compared to rubber dam for composite restorations longevity in primary molars. Furthermore, the latest presented the disadvantage of higher cost and longer procedure time. Clinical Significance The moisture control method does not influence the longevity of composite restorations in primary molars. Cotton roll isolation proved to be non-inferior to rubber dam isolation and is a viable option for restoring primary molars. Clinical trial registration registered NCT03733522 on 07/11/2018. The present trial was nested within another clinical trial, the CARies DEtection in Children (CARDEC-03-NCT03520309).
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.