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Effect of CMR With Different Restorative Materials on Clinical Performance of Indirect Onlay Restorations

Sponsor
Mansoura University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT06155773
Collaborator
(none)
64
Enrollment
1
Location
4
Arms
40.3
Anticipated Duration (Months)
1.6
Patients Per Site Per Month

Study Details

Study Description

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 CAD/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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Highly viscous glass ionomer (cervical margin relocation)
  • Procedure: Low shrinkage Flowable Composite (cervical margin relocation)
  • Procedure: Resin Modified Glass Ionomer (cervical margin relocation)
  • Procedure: Bioactive Ionic Resin (cervical margin relocation)
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
64 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Masking Description:
double blind
Primary Purpose:
Treatment
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
Actual Study Start Date :
Aug 24, 2021
Actual Primary Completion Date :
Jan 5, 2022
Anticipated Study Completion Date :
Jan 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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

Procedure: Highly viscous glass ionomer (cervical margin relocation)
different dental restorative materials used to relocate deep cervical margins before receiving onlay restorations
Experimental: 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

Procedure: Low shrinkage Flowable Composite (cervical margin relocation)
different dental restorative materials used to relocate deep cervical margins before receiving onlay restorations
Experimental: 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

Procedure: Resin Modified Glass Ionomer (cervical margin relocation)
different dental restorative materials used to relocate deep cervical margins before receiving onlay restorations
Experimental: 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

Procedure: Bioactive Ionic Resin (cervical margin relocation)
different dental restorative materials used to relocate deep cervical margins before receiving onlay restorations

Outcome Measures

Primary Outcome Measures

  1. Gingival health [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

  2. modified FDI (International Dental Federation) clinical Criteria [three year follow up]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 40 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  • Good general health

  • Good oral hygiene

  • Patient aging 20-40 y

  • Patients with proximal deep carious lesion

  • ICDAS (International caries detection and assessment system) 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Faculty of dentistry , Mansoura University Mansoura Dakahlia Egypt

Sponsors and Collaborators

  • Mansoura University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mansoura University
ClinicalTrials.gov Identifier:
NCT06155773
Other Study ID Numbers:
  • 9153193
First Posted:
Dec 4, 2023
Last Update Posted:
Dec 4, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Dental Caries
Methamphetamine

Study Results

No Results Posted as of Dec 4, 2023