Novel Self-Adhesive Composite Hybrid Versus Conventional Composite in Restoration of Carious Primary Teeth.

Study Overview
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Brief Summary
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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
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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.

Official Title
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Novel Self-Adhesive Composite Hybrid Versus Conventional Composite in Restoration of Carious Primary Teeth. A Split Mouth Randomized Clinical Trial

Conditions
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Dental Caries in Children

Intervention / Treatment
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* Other: Novel self-adhesive hybrid composite(Surefil one)


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Children: Good general health and medically free patients. Age ranges: from 4-7 years old. A provided informed consent by the parents. Acceptable child cooperation. Teeth: Class I carious primary teeth. 2 contralateral or adjacent carious teeth. Simple caries, extending to the dentin. No singe or symptom of pulp inflammation. Normal radiographic examination. Exclusion Criteria: Children: Unable to attend follow-up visits. Refusal of participation. Teeth: Symptom tooth. Periapical Pathosis. Mobile primary tooth.

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 7 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: for both the intervention group and control group, the procedure and follow up will be done parallel to each other(same time).
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Novel self-adhesive composite restoration (Surefil one)<br> | Other: Novel self-adhesive hybrid composite(Surefil one)<br>* Surefil one, is a recent introduced esthetic dental restoration for treatment of carious teeth.<br>|
| Active Comparator: conventional composite resin restoration(VOCO Grandio)<br> | Other: Novel self-adhesive hybrid composite(Surefil one)<br>* Surefil one, is a recent introduced esthetic dental restoration for treatment of carious teeth.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical effectiveness | The two materials will be evaluated using the FDI World Federation criteria. | 6 month intervene | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The cost effectiveness | will be measured using the ICER (Incremental cost-effectiveness ratio) | 6 month intervene | 
| Duration of procedure | measure using stop watch | 6 month intervene | 
| Child cooperation | Wright Modification of Frankl behavior scale will be use(Rating1-5 as R1 definitely negative, and R5 definitely positive). | 6 month intervene |