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

February 7, 2023 updated by: Maryam Salim Dawood, Cairo University
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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 11511
        • Recruiting
        • Faculty of Dentistry, Cairo University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 25 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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
Procedure: 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
ACTIVE_COMPARATOR: 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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
marginal discoloration
Time Frame: 3 months
ordinal criteria scoring system (ordinal)
3 months
marginal discoloration
Time Frame: 6 months
ordinal criteria scoring system (ordinal)
6 months
marginal discoloration
Time Frame: 12 months
ordinal criteria scoring system (ordinal)
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
color change
Time Frame: 3 month
ordinal criteria scoring system (ordinal)
3 month
color change
Time Frame: 6 month
ordinal criteria scoring system (ordinal)
6 month
color change
Time Frame: 12 month
ordinal criteria scoring system (ordinal)
12 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 4, 2021

Primary Completion (ANTICIPATED)

March 1, 2023

Study Completion (ANTICIPATED)

May 1, 2023

Study Registration Dates

First Submitted

June 9, 2022

First Submitted That Met QC Criteria

November 10, 2022

First Posted (ACTUAL)

November 14, 2022

Study Record Updates

Last Update Posted (ESTIMATE)

February 9, 2023

Last Update Submitted That Met QC Criteria

February 7, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14422019474770

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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