Clinical Performance of Onlay Restorations After Cervical Margin Relocation (CMR)

NCT ID: NCT06155773

Last Updated: 2023-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-24

Study Completion Date

2025-01-31

Brief Summary

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The current study intends to evaluate the effect of cervical margin relocation with different restorative materials on three-year clinical performance of indirect Computer-Aided-Design (CAD)/ Computer-Aided-Manufacture (CAM) onlay restorations. This study is designed to test the null hypothesis that the three-year clinical performance of onlay restorations is significantly affected by cervical margin relocation with different restorative materials.

Detailed Description

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Conditions

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Dental Caries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
double blind

Study Groups

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Highly viscous Glass Ionomer

Highly viscous glass ionomer restoration is used to elevate the subgingival cervical margin in deep class II cavities before receiving cad/cam onlay restoration

Group Type EXPERIMENTAL

Highly viscous glass ionomer (cervical margin relocation)

Intervention Type PROCEDURE

different dental restorative materials used to relocate deep cervical margins before receiving onlay restorations

Low shrinkage Flowable Composite

Low shrinkage Flowable Composite restoration is used to elevate the subgingival cervical margin in deep class II cavities before receiving cad/cam onlay restoration

Group Type EXPERIMENTAL

Low shrinkage Flowable Composite (cervical margin relocation)

Intervention Type PROCEDURE

different dental restorative materials used to relocate deep cervical margins before receiving onlay restorations

Resin Modified Glass Ionomer

Resin Modified Glass Ionomer restoration is used to elevate the subgingival cervical margin in deep class II cavities before receiving cad/cam onlay restoration

Group Type EXPERIMENTAL

Resin Modified Glass Ionomer (cervical margin relocation)

Intervention Type PROCEDURE

different dental restorative materials used to relocate deep cervical margins before receiving onlay restorations

Bioactive Ionic Resin

Bioactive Ionic Resin restoration is used to elevate the subgingival cervical margin in deep class II cavities before receiving cad/cam onlay restoration

Group Type EXPERIMENTAL

Bioactive Ionic Resin (cervical margin relocation)

Intervention Type PROCEDURE

different dental restorative materials used to relocate deep cervical margins before receiving onlay restorations

Interventions

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Highly viscous glass ionomer (cervical margin relocation)

different dental restorative materials used to relocate deep cervical margins before receiving onlay restorations

Intervention Type PROCEDURE

Low shrinkage Flowable Composite (cervical margin relocation)

different dental restorative materials used to relocate deep cervical margins before receiving onlay restorations

Intervention Type PROCEDURE

Resin Modified Glass Ionomer (cervical margin relocation)

different dental restorative materials used to relocate deep cervical margins before receiving onlay restorations

Intervention Type PROCEDURE

Bioactive Ionic Resin (cervical margin relocation)

different dental restorative materials used to relocate deep cervical margins before receiving onlay restorations

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Good general health
* Good oral hygiene
* Patient aging 20-40 y
* Patients with proximal deep carious lesion
* International caries detection and assessment system (ICDAS) 4 or 5 that diagnosed clinically and radiographically.
* Normal response to a vitality test.

Exclusion Criteria

* poor general health
* poor oral hygiene
* Teeth would need direct pulp capping
* Teeth act as abutment for fixed or removable prosthesis.
* patients with excessive parafunctional habits
* Patient potentially unable to be compliant to recall visits
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Faculty of dentistry , Mansoura University

Al Mansurah, Dakahlia Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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9153193

Identifier Type: -

Identifier Source: org_study_id