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

Dental Caries Clinical Trial

Official title:

Effect of Cervical Margin Relocation With Different Restorative Materials on Three-year Clinical Performance and In-Vitro Fracture Resistance of Indirect Hybrid Ceramic Onlay Restorations

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06155773
• Other study ID #: 9153193
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 24, 2021
• Est. completion date: January 2025

Study information

• Verified date: May 2023
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 64
• Est. completion date: January 2025
• Est. primary completion date: January 5, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Dental Caries

Intervention

Procedure:
• Highly viscous glass ionomer (cervical margin relocation)
different dental restorative materials used to relocate deep cervical margins before receiving onlay restorations
• Low shrinkage Flowable Composite (cervical margin relocation)
different dental restorative materials used to relocate deep cervical margins before receiving onlay restorations
• Resin Modified Glass Ionomer (cervical margin relocation)
different dental restorative materials used to relocate deep cervical margins before receiving onlay restorations
• Bioactive Ionic Resin (cervical margin relocation)
different dental restorative materials used to relocate deep cervical margins before receiving onlay restorations

Locations

Country	Name	City	State
Egypt	Faculty of dentistry , Mansoura University	Mansoura	Dakahlia

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	three year follow up
Primary	Modified World Dental Federation (FDI) clinical Criteria	Functional Properties of restorations: Fracture of material and retention; Marginal adaptation; Radiographic examination; Biological Properties of restorations; Postoperative (hyper-sensitivity and tooth vitality; Recurrence of caries; Tooth integrity (enamel cracks, tooth fractures); Periodontal Response; 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	three year follow up