Evaluation of Using Self-adhering Flowable Resin Composite in Repairing Old Defective Resin Composite Restorations Over 18 Months Follow up. (A Randomized Clinical Trial)

NCT06260644 | Active Not Recruiting DMC

• 1 other identifier: Repairing defective composite
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

This research proposal is evaluating the clinical performance of using self-adhering flowable resin composite in repairing old occlusal defective resin composite versus conventional flowable resin composite restoration over 18 months.

Conditions

Occlusal Caries

Keywords

flowable resin composite

Outcome Measures

Primary Outcomes (1)

• Restoration clinical performance using FDI criteria

  FDI criteria mechanical parameters

  assessment will be done after the treatment then 6 months, 12 months and18 months.

Study Arms (2)

Conventional flowable nano filled resin composite

ACTIVE COMPARATOR

Repairing the old defective class I composite restoration by conventional nano filled flowable resin composite.

Procedure: VertiseTM flowable composite (Kerr,USA)

Self adhesive flowable resin composite

EXPERIMENTAL

Repairing the old defective class I composite restoration by self adhering flowable resin composite.

Procedure: VertiseTM flowable composite (Kerr,USA)

Interventions

VertiseTM flowable composite (Kerr,USA) PROCEDURE

self adhesive flowable resin composite restoration.

Conventional flowable nano filled resin composite; Self adhesive flowable resin composite

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients (18-35 y)
• patients with defective resin composite class I restorations that need repair.
• dental motivated patients who attends regularly.
• Vital posterior teeth with repairable defective resin composite class I restorations.
• Localized marginal defect or marginal staining FDI 3\& 4.
• Teeth with no or minimum mobility \& healthy peridontium.
• No history of any irreversible pulpal pain or necrosis in the teeth to be restored.

You may not qualify if:

• Patients with defective restorations that dictate replacement
• Uncooperative behavior limits the isolation techniques throughout the procedure.
• Presence of parafunctional habits.
• Patient with history of systemic medical disease, or any other serious relevant problem.
• High caries risk patients. Periodontal disease that may affect the prognosis of the restoration or the tooth itself.
• Fractured or visibly cracked teeth.
• Symptoms of any pulp pathosis.
• Defective resin composite restorations that dictate replacement.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry

Cairo, 113311, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: double ( participants, outcomes assessor) participants and both assessors will be blind to the type of material used
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: masters degree student

Model Details: parallel assignment

Study Record Dates

• First Submitted: February 7, 2024
• First Posted: February 15, 2024
• Study Start: February 1, 2024
• Primary Completion: September 1, 2025
• Study Completion: October 1, 2025
• Last Updated: February 15, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)