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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-31

Study Completion Date

2023-06-30

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.

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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.

Conditions

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Dental Caries in Children

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

for both the intervention group and control group, the procedure and follow up will be done parallel to each other(same time).

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Novel self-adhesive composite restoration (Surefil one)

Group Type ACTIVE_COMPARATOR

Novel self-adhesive hybrid composite(Surefil one)

Intervention Type OTHER

Surefil one, is a recent introduced esthetic dental restoration for treatment of carious teeth.

conventional composite resin restoration(VOCO Grandio)

Group Type ACTIVE_COMPARATOR

Novel self-adhesive hybrid composite(Surefil one)

Intervention Type OTHER

Surefil one, is a recent introduced esthetic dental restoration for treatment of carious teeth.

Interventions

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Novel self-adhesive hybrid composite(Surefil one)

Surefil one, is a recent introduced esthetic dental restoration for treatment of carious teeth.

Intervention Type OTHER

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.