Dental Caries in Children
Conditions
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.
Interventions
OTHERNovel self-adhesive hybrid composite(Surefil one)
Surefil one, is a recent introduced esthetic dental restoration for treatment of carious teeth.
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
for both the intervention group and control group, the procedure and follow up will be done parallel to each other(same time).
Eligibility
Sex/Gender
ALL
Age
4 Years to 7 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| clinical effectiveness | 6 month intervene | The two materials will be evaluated using the FDI World Federation criteria. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The cost effectiveness | 6 month intervene | will be measured using the ICER (Incremental cost-effectiveness ratio) |
| Duration of procedure | 6 month intervene | measure using stop watch |
| Child cooperation | 6 month intervene | Wright Modification of Frankl behavior scale will be use(Rating1-5 as R1 definitely negative, and R5 definitely positive). |
Contacts
Primary Contactfatima E Rabie, BDS
Backup ContactPassant Nagi, PHD
Outcome results
None listed