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

Mansoura University64 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Dental Caries

Interventions

Highly viscous glass ionomer (cervical margin relocation)PROCEDURE

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

Low shrinkage Flowable Composite (cervical margin relocation)PROCEDURE

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

Resin Modified Glass Ionomer (cervical margin relocation)PROCEDURE

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

Eligibility

Sex: ALLMin age: 20 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Faculty of dentistry , Mansoura University

Al Mansurah, Dakahlia Governorate, Egypt

Outcomes

Primary Outcomes

Gingiva

Gingival Index Scale from 0 to 3 will be used for evaluation considering that score 0 represents normal gigiva while score 3 represents severely inflamed gingiva

Time frame: three year follow up

Modified World Dental Federation (FDI) clinical Criteria

1. Functional Properties of restorations: 1. Fracture of material and retention 2. Marginal adaptation 3. Radiographic examination 2. Biological Properties of restorations 1. Postoperative (hyper-sensitivity and tooth vitality 2. Recurrence of caries 3. Tooth integrity (enamel cracks, tooth fractures) 4. Periodontal Response 5. Adjacent mucosa Descriptive scale from 1 to 5. Note: 1 is clinically excellent 5 is clinically poor. Scores(1-3) are considered sufficient The overall cumulative success rate of restorations will be evaluated

Time frame: three year follow up

Data from ClinicalTrials.gov

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