Dental Caries, Composite Resins, Composite Restoration
Conditions
Keywords
Clinical, FDI criteria, Biodentin, Composite Restorations, Dentin Replacement
Brief summary
This randomized controlled clinical trial is designed to clinically evaluate and compare the performance of five dentin replacement materials used beneath posterior composite restorations.
Detailed description
Thirty patients ranging in age from 20 to 35 years will be enrolled into the study. This study will be designed as a randomized controlled clinical trial including patients requiring six Class I restorations. Participants will be randomly allocated into six groups according to the type of dentin replacement material used: Group I (Biodentin), Group II (Activa Bioactive), Group III (Glass ionomer cement), Group IV (Ever x posterior), and Group V (Flowable resin). Restorations will be placed following standardized cavity preparation and manufacturer instructions. Clinical evaluation will be performed at baseline and 6, 12, and 18 months using modified FDI criteria, assessing retention, marginal integrity, surface roughness, anatomical form, postoperative sensitivity, and secondary caries. Data will be collected and statistically analyzed
Interventions
OTHERBiodentine
Biodentine will be used as a dentin replacement material in standardized posterior Class I cavities before placement of the definitive composite restoration. The material will be applied according to the manufacturer's instructions
OTHERACTIVA BioACTIVE
ACTIVA BioACTIVE will be used as a dentin replacement material in standardized posterior Class I cavities before placement of the definitive composite restoration. The material will be applied according to the manufacturer's instructions.
OTHERglass ionomer cement
Glass ionomer cement will be used as a dentin replacement material in standardized posterior Class I cavities before placement of the definitive composite restoration. The material will be applied according to the manufacturer's instructions.
OTHEReverX Posterior
everX Posterior will be used as a dentin replacement material in standardized posterior Class I cavities before placement of the definitive composite restoration. The material will be applied according to the manufacturer's instructions.
Flowable resin composite will be used as a dentin replacement material in standardized posterior Class I cavities before placement of the definitive composite restoration. The material will be applied according to the manufacturer's instructions.
Sponsors
Tanta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Double (Participant, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
25 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Patients who are medically able to undergo routine dental restorative treatment. * Patients willing and able to provide written informed consent. * Patients with adequate oral hygiene and periodontal health for participation in the study. * Patients requiring posterior Class I restorations
Exclusion criteria
* Patients with systemic conditions that contraindicate routine dental treatment. * Patients unable or unwilling to provide informed consent. * Patients with poor compliance or inability to attend scheduled follow-up visits. * Teeth with clinical or radiographic evidence of irreversible pulpitis, pulp necrosis, or periapical pathology.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| marginal adaptation | 18 months | Clinical evaluation of marginal adaptation was conducted in accordance with the World Dental Federation (FDI) criteria by two calibrated examiners at baseline and after 6, 12, and 18 months. Each restoration was assessed and categorized according to the degree of conformity with the established criteria as follows: score 1, clinically excellent; scores 2 and 3, clinically satisfactory; and scores 4 and 5, clinically inadequate. Scores of 1-3 were considered indicative of clinical success, whereas scores of 4 or 5 were considered indicative of failure. Visual assessment was performed under adequate illumination using a high-intensity light source and a dental magnifying loupe to facilitate accurate evaluation. For statistical analysis, the Friedman test was used to assess within-group changes in restoration outcomes across the different follow-up periods. The Kruskal-Wallis test was applied to compare restoration outcomes among the different groups at each corresponding follow-up. |
Countries
Egypt
Outcome results
None listed