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Clinical Trials/NCT05173753
NCT05173753UnknownNot Applicable

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

Cairo University0 sites60 target enrollmentStarted: August 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
60
Primary Endpoint
clinical effectiveness

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
4 Years to 7 Years (Child)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Unable to attend follow-up visits. Refusal of participation.
  • Symptom tooth. Periapical Pathosis. Mobile primary tooth.

Outcomes

Primary Outcomes

clinical effectiveness

Time Frame: 6 month intervene

The two materials will be evaluated using the FDI World Federation criteria.

Secondary Outcomes

  • Duration of procedure(6 month intervene)
  • The cost effectiveness(6 month intervene)
  • Child cooperation(6 month intervene)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Fatima Elfadil Rabie

Principal investigator

Cairo University

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