Novel Self-Adhesive Composite Hybrid Versus Conventional Composite in Restoration of Carious Primary Teeth.
- Conditions
- Dental Caries in Children
- Interventions
- Other: Novel self-adhesive hybrid composite(Surefil one)
- Registration Number
- NCT05173753
- Lead Sponsor
- Cairo University
- Brief Summary
The clinical trial aim to evaluate clinical effectiveness of self-adhesive composite hybrid (Surefil one) versus conventional composite(VOCO Grandio) as restorative material for carious primary teeth.
- Detailed Description
Composite resin is a continuous improving material as its full fill many requirements seeking in dental restorative materials, but is the new introducing composite resin material is always better than the previous one? This randomized clinical trial is performed to discus and assess that hypothesis. A total of 120 class I restoration(60 Surefil one novel self-adhesive composite hybrid \& 60 VOCO Grandio conventional composite resin) will be placed in posterior teeth of 60 volunteers(splint mouth design) following the manufacturer instruction. age between 4-7 years. The restorations will then be evaluate clinically at baseline, 3, and 6 month intervene. Both the procedure and follow up will done in the out-patient clinic, Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Cairo University, Cairo, Egypt.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 60
Not provided
Children:
Unable to attend follow-up visits. Refusal of participation.
Teeth:
Symptom tooth. Periapical Pathosis. Mobile primary tooth.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Novel self-adhesive composite restoration (Surefil one) Novel self-adhesive hybrid composite(Surefil one) - conventional composite resin restoration(VOCO Grandio) Novel self-adhesive hybrid composite(Surefil one) -
- Primary Outcome Measures
Name Time Method clinical effectiveness 6 month intervene The two materials will be evaluated using the FDI World Federation criteria.
- Secondary Outcome Measures
Name Time Method The cost effectiveness 6 month intervene will be measured using the ICER (Incremental cost-effectiveness ratio)
Child cooperation 6 month intervene Wright Modification of Frankl behavior scale will be use(Rating1-5 as R1 definitely negative, and R5 definitely positive).
Duration of procedure 6 month intervene measure using stop watch