Clinical Evaluation of Subgingival Open Sandwich Restorations

Dental Restoration Failure of Marginal Integrity Clinical Trial

Official title:

Clinical Evaluation of Subgingival Open Sandwich Restorations: 3-year Results of a Randomized Double-blind Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05125900
• Other study ID #: A01111219
• Status: Completed
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: January 1, 2023

Study information

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

Clinical Trial Summary

This study was designed to evaluate and compare the 3-year periodontal responses and clinical performance of proximal subgingival open sandwich restorations using three different glass ionomer-based restorative materials and flowable composite.

Description:

The description of the experimental design followed the Consolidated Standards of Reporting Trials (CONSORT) statement. The present study was a double-blinded (patients and examiner) randomized clinical trial anticipating the parallel design. Ninety-five adult patients seeking dental treatment in the Operative Department clinic at the Faculty of Dentistry, University of Mansoura were enrolled in the current study with a total of 120 Class II restorations. No advertisement was made for participant recruitment, forming a sample of convenience. Each patient must signs a consent form before participating in the current study. The study was conducted from January 2020 to January 2023 as a part of the Doctoral dissertation. Mansoura University institution's ethics committee approved the form and protocol before conducting the study. The sample size was calculated based on the clinical success rate (100% success rate at 2 years) of posterior class II restorations restored with open sandwich and deep margin elevation techniques observed in previous studies. According to several parameters including a significance level of 5%, the power of the test was calculated to be 80%, and equivalent limit of 15%. Upon these data, a sample size of 120 subjects was appropriate to allow for a 20% drop-out.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: January 1, 2023
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 50 Years

Eligibility

Inclusion Criteria:

• Patients with one proximal sub gingival carious lesion ICDAS 4, or 5 in posterior teeth
• Patients must have a good oral hygiene;
• Patients with tooth gives positive response to testing with an electric pulp tester
• Patients with normal and full occlusion,
• Patients with opposing teeth should be natural with no restorations.

Exclusion Criteria:

• High caries risk patients with extremely poor oral hygiene,
• Patients involved in orthodontic treatment or periodontal surgery,
• Patients with periodontally involved teeth (chronic periodontitis)
• Patients with abutments should be excluded.
• Patients with heavy bruxism habits and clenching

Related Conditions & MeSH terms

• Dental Restoration Failure of Marginal Integrity

Intervention

Other:
• Proximal box elevation using one of the tested materials
Each patient randomly received deep proximal margin elevation with one of the tested restorative materials, while the overlying restorations were all the same regular bulk fill resin composite

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry-Mansoura University	Mansoura	Dakahliya

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients with periodontal problems	The periodontal situation of patients were examined based on bleeding on probing, plaque index and probing depth scores	3 years after restoration
Primary	Percentage of aesthetic, functional and biological properties for each base material restorations	Percentage of aesthetic, functional and biological properties were clinically assessed using World Dental Federation parameters for each base material group	3 years after restoration
Secondary	Radiographic examination	Each base material/gingival dentin interface was examined radiographically each 6 months period.	3 years after restoration