Trial reportBMC oral health2024
Two-year clinical and radiographic evaluation of ACTIVA BioACTIVE versus Compomer (Dyract® eXtra) in the restoration of class-2 cavities of primary molars: a non-inferior split-mouth randomised clinical trial.
Trial report in BMC oral health, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03516838 (Clinical and Radiographic Evaluation of a New Bioactive Ionic Resin Material), which is not on this map. Cited by 7 papers.
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.
Clinical and Radiographic Evaluation of a New Bioactive Ionic Resin Material (ACTIVA™ BioACTIVE) Versus Compomer for Class II Restorations in Primary Molars: A Split Mouth Randomized Clinical Trial
Who cites it
7 citing papers in PubMed.
- Review
- The Clinical Performance of Activa Bioactive Composite Compared to Composite in Restoring Class II Cavities in Primary Teeth: 1 Year of Split-Mouth Randomized Clinical Trial.European journal of dentistry · 2026Article
- Bioactive restorative materials in dentistry: a comprehensive review of mechanisms, clinical applications, and future directions.Odontology · 2026Review
- Clinical and Laboratory Performance of ACTIVA BioACTIVE Restorative in Primary Teeth: A Systematic Review of Pediatric Evidence.Journal of clinical medicine · 2026Review
- Clinical Performance of Bulk-Fill Versus Incremental Composite Restorations in Primary Teeth: A Systematic Review of In Vivo Evidence.Dentistry journal · 2025Review
- A Critical Review on the Factors Affecting the Bond Strength of Direct Restorative Material Alternatives to Amalgam.Materials (Basel, Switzerland) · 2024Review
- A Historical Perspective on Dental Composite Restorative Materials.Journal of functional biomaterials · 2024Review
Corrections and comments
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Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesThe trial aimed to compare the clinical performance and radiographic success of ACTIVA BioACTIVE versus Compomer in restoring class-II cavities of primary molars. MATERIALS AND
methodsA non-inferior split-mouth design was considered. A pre-calculated sample size of 96 molars (48 per group) with class-2 cavities of twenty-one children whose ages ranged from 5 to 10 years were randomly included in the trial. Pre-operative Plaque Index (PI), DMFT/dmft scores and the time required to fill the cavity were recorded. Over 24 months, the teeth were clinically evaluated every six months and radiographically every 12 months by two calibrated and blinded evaluators using the United States public health service (USPHS)-Ryge criteria. The two-sided 95% confidence interval (CI) for the difference in success rate was considered to assess non-inferiority, and the margin was set at -18%. The linear mixed model and Firth's logistic regression model were used for data analysis (P < 0.05).
resultsAfter 24 months, 86 teeth (43 per group) were evaluated. The mean PI score was 1.1(± 0.9), while DMFT/dmft was 0.35 (± 0.74) and 6.55 (± 2.25) respectively. The clinical and radiographic success rate of Dyract vs. ACTIVA was 95.3% and 88.3% vs. 93% and 86%, respectively. The two-sided 95% CI for the difference in success rate (-2.3%) was - 3.2 to 1.3% and didn't reach the predetermined margin of -18% which had been anticipated as the non-inferiority margin. Clinically, ACTIVA had a significantly better colour match (P = 0.002) but worse marginal discolouration (P = 0.0143). There were no significant differences regarding other clinical or radiographic criteria (P > 0.05). ACTIVA took significantly less placement time than Dyract, with a mean difference of 2.37 (± 0.63) minutes (P < 0.001).
conclusionThe performance of ACTIVA was not inferior to Dyract and both materials had a comparable high clinical and radiographic performance in children with high-caries experience. ACTIVA had a significantly better colour match but more marginal discolouration. It took significantly less time to be placed in the oral cavity.
trial registrationThe study was registered at ClinicalTrials.gov on 4 May 2018 (#NCT03516838).
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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.