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

Cairo University (CU)

Status: Not yet enrolling

Conditions: Dental Caries in Children

Treatments: Other: Novel self-adhesive hybrid composite(Surefil one)

Study type: Interventional

Funder types: Other

Identifiers

NCT05173753

Surefil one in primary teeth

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 4 to 7 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Novel self-adhesive composite restoration (Surefil one)

Active Comparator group

Treatment:

Other: Novel self-adhesive hybrid composite(Surefil one)

conventional composite resin restoration(VOCO Grandio)

Active Comparator group

Treatment:

Other: Novel self-adhesive hybrid composite(Surefil one)