Clinical Evaluation of Subgingival Open Sandwich Restorations

Mansoura University

Status: Completed

Conditions: Dental Restoration Failure of Marginal Integrity

Treatments: Other: Proximal box elevation using one of the tested materials

Study type: Interventional

Funder types: Other

Identifiers

NCT05125900

A01111219

Details and patient eligibility

About

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.

Full 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.

Enrollment: 95 patients

Sex: All

Ages: 21 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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95 participants in 4 patient groups, including a placebo group

Resin modified glass ionomer

Active Comparator group

Description:

Group received proximal box elevation using resin modified glass ionomer

Treatment:

Other: Proximal box elevation using one of the tested materials

Glass hybrid

Placebo Comparator group

Description:

Group received proximal box elevation using glass hybrid

Treatment:

Other: Proximal box elevation using one of the tested materials

Bulk fill flowable resin composite

Active Comparator group

Description:

Group received proximal box elevation using bulk fill flowable resin composite

Treatment:

Other: Proximal box elevation using one of the tested materials

Ion-releasing material

Placebo Comparator group

Description:

Group received proximal box elevation using ion-releasing material

Treatment:

Other: Proximal box elevation using one of the tested materials