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Clinical Trials/NCT06155773
NCT06155773
Active, not recruiting
Not Applicable

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

Mansoura University1 site in 1 country64 target enrollmentAugust 24, 2021
ConditionsDental Caries

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Dental Caries
Sponsor
Mansoura University
Enrollment
64
Locations
1
Primary Endpoint
Modified World Dental Federation (FDI) clinical Criteria
Status
Active, not recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 24, 2021
End Date
January 2025
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Modified World Dental Federation (FDI) clinical Criteria

Time Frame: three year follow up

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

Gingiva

Time Frame: three year follow up

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

Study Sites (1)

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