Clinical Performance of Onlay Restorations After Cervical Margin Relocation (CMR)
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
1 other identifier
interventional
64
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2021
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 24, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 5, 2022
CompletedFirst Submitted
Initial submission to the registry
October 17, 2023
CompletedFirst Posted
Study publicly available on registry
December 4, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2025
CompletedDecember 8, 2023
May 1, 2023
4 months
October 17, 2023
December 3, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
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
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
three year follow up
Study Arms (4)
Highly viscous Glass Ionomer
EXPERIMENTALHighly viscous glass ionomer restoration is used to elevate the subgingival cervical margin in deep class II cavities before receiving cad/cam onlay restoration
Low shrinkage Flowable Composite
EXPERIMENTALLow shrinkage Flowable Composite restoration is used to elevate the subgingival cervical margin in deep class II cavities before receiving cad/cam onlay restoration
Resin Modified Glass Ionomer
EXPERIMENTALResin Modified Glass Ionomer restoration is used to elevate the subgingival cervical margin in deep class II cavities before receiving cad/cam onlay restoration
Bioactive Ionic Resin
EXPERIMENTALBioactive Ionic Resin restoration is used to elevate the subgingival cervical margin in deep class II cavities before receiving cad/cam onlay restoration
Interventions
different dental restorative materials used to relocate deep cervical margins before receiving onlay restorations
different dental restorative materials used to relocate deep cervical margins before receiving onlay restorations
different dental restorative materials used to relocate deep cervical margins before receiving onlay restorations
different dental restorative materials used to relocate deep cervical margins before receiving onlay restorations
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Faculty of dentistry , Mansoura University
Al Mansurah, Dakahlia Governorate, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- double blind
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 17, 2023
First Posted
December 4, 2023
Study Start
August 24, 2021
Primary Completion
January 5, 2022
Study Completion
January 1, 2025
Last Updated
December 8, 2023
Record last verified: 2023-05