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

NCT ID: NCT05614076

Last Updated: 2023-02-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-04
• Study Completion Date: 2023-05-31

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

Conditions

Class V Dental Caries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Conservation of the demineralized chalky white enamel margin 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

Group Type: EXPERIMENTAL

conserved chalky white enamel margins of class V cavities

Intervention Type: PROCEDURE

during cavity preparation, we conserved chalky white enamel margins of class V cavities and then restored them with resin composite restorations,we assessed the restorations with visual inspection using a mirror and explorer according to USPHS Criteria

Total removal of demineralized enamel margin 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

Group Type: ACTIVE_COMPARATOR

Total removal of demineralized enamel margins of class V cavities

Intervention Type: PROCEDURE

during cavity preparation, we removed the total chalky white enamel margins of class V cavities and then restored them with resin composite restorations, we assessed the restorations with visual inspection using a mirror and explorer according to USPHS Criteria

Interventions

conserved chalky white enamel margins of class V cavities

during cavity preparation, we conserved chalky white enamel margins of class V cavities and then restored them with resin composite restorations,we assessed the restorations with visual inspection using a mirror and explorer according to USPHS Criteria

Intervention Type: PROCEDURE

Total removal of demineralized enamel margins of class V cavities

during cavity preparation, we removed the total chalky white enamel margins of class V cavities and then restored them with resin composite restorations, we assessed the restorations with visual inspection using a mirror and explorer according to USPHS Criteria

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Maryam Salim Dawood

main investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of dentistry, Cairo University

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Maryam Salim Dawood, master

Role: CONTACT

maryam.salim@dentistry.cu.edu.eg

00201011270500

Mohamed Refaat El-Bialy, PHD

Role: CONTACT

mohamed.refaat@dentistry.cu.edu.eg

00201202552666

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Other Identifiers

14422019474770

Identifier Type: -

Identifier Source: org_study_id