Clinical Performance Of Conserved Chalky White Demineralized Enamel Cavity Margins Versus Totally Removed Carious Margins In Class V Cavities Restored With Composite Resin

Not Applicable

Recruiting

• Conditions: Class V Dental Caries
• Interventions: Procedure: Total removal of demineralized enamel margins of class V cavities; Procedure: conserved chalky white enamel margins of class V cavities

• Registration Number: NCT05614076
• Lead Sponsor: Cairo University

Brief Summary

This study aims to compare the clinical performance of conserved chalky white demineralized enamel margins with total removal of demineralized enamel margins in class v cavities restored with composite in patients with acute carious cervical lesions

Detailed Description

With limited evidence-based information about the clinical performance of conserved white chalky enamel margins in class v .it is beneficial to compare the newly concept of preserved the white chalky deminerlized enamel margins using a randomized clinical trial to test the null hypothesis that this new concept has the same clinical performance as total removal of demineralized enamel margins in class v cavities restored with composite in patients with acute carious cervical lesions .The comparator will be the concept of total removal of demineralized enamel margins in class v cavities restored with composite Patients are selected according to the eligibility criteria, Local anesthesia will be administered and the operative field will be isolated before starting the restorative procedure. For the comparator group, standard class V cavities will be prepared at labial surface with totally removed carious enamel margins. For interventional group, class V cavity prepared at labial surface with preserved the chalky demineralized enamel margins then applications of remineralizing agent(MI paste plus) before the application of resin composite restoration. Local anesthesia will be administered and the operative field will be isolated before starting the restorative procedure. For control group, standard class V cavities will be prepared at labial surface with totally removed carious enamel margins. For experimental group, class V cavity prepared at labial surface with preserved the chalky demineralized enamel margins then applications of remineralizing agent(MI paste plus) before the application of resin composite restoration. both cavities groups restored with resin composite restorations. The restorations are assessed using the modified USPHS criteria at the time intervals stated in the outcome measures

Study Timeline

• Study Start: 2021-11-04
• Study First Submitted: 2022-06-09
• Study First Submitted QC: 2022-11-10
• Study First Posted: 2022-11-14
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-07
• Last Update Posted: 2023-02-09
• Primary Completion: 2023-03
• Study Completion: 2023-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

• class V carious lesions in premolars and molars.
• Vital upper or lower teeth with no signs of irreversible pulpitis.
• Presence of favorable occlusion and teeth are in normal contact with the adjacent teeth.

Exclusion Criteria

• Deep carious defects (close to pulp, less than 1 mm distance).
• Periapical pathology or signs of pulpal pathology.
• Endodontically treated teeth
• Tooth hypersensitivity.
• Possible prosthodontic restoration of teeth.
• Heavy occlusion or occlusal contacts or history of bruxism.
• Severe periodontal affection

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Total removal of demineralized enamel margin of class V cavities	Total removal of demineralized enamel margins of class V cavities	for cavity design in this arm is Total removal of demineralized enamel margin of class V cavities and restoration with resin composite
Conservation of the demineralized chalky white enamel margin of class V cavities	conserved chalky white enamel margins of class V cavities	for cavity design in this arm we Conserved the demineralized chalky white enamel margin of class V cavities then application of resin composite restoration

Primary Outcome Measures

Name	Time	Method
marginal discoloration	12 months	ordinal criteria scoring system (ordinal)

Secondary Outcome Measures

Name	Time	Method
color change	12 month	ordinal criteria scoring system (ordinal)

Trial Locations

Locations (1)

Faculty of dentistry, Cairo University; 🇪🇬 Cairo, Egypt