Clinical Evaluation of Subgingival Open Sandwich Restorations

Not Applicable

Completed

• Conditions: Dental Restoration Failure of Marginal Integrity
• Interventions: Other: Proximal box elevation using one of the tested materials

• Registration Number: NCT05125900
• Lead Sponsor: Mansoura University

Brief 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.

Detailed 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2020-01-01
• Study First Submitted: 2021-11-08
• Study First Submitted QC: 2021-11-08
• Study First Posted: 2021-11-18
• Primary Completion: 2022-01-01
• Study Completion: 2023-01-01
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-12
• Last Update Posted: 2023-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 95

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Glass hybrid	Proximal box elevation using one of the tested materials	Group received proximal box elevation using glass hybrid
Bulk fill flowable resin composite	Proximal box elevation using one of the tested materials	Group received proximal box elevation using bulk fill flowable resin composite
Resin modified glass ionomer	Proximal box elevation using one of the tested materials	Group received proximal box elevation using resin modified glass ionomer
Ion-releasing material	Proximal box elevation using one of the tested materials	Group received proximal box elevation using ion-releasing material

Primary Outcome Measures

Name	Time	Method
Percentage of aesthetic, functional and biological properties for each base material restorations	3 years after restoration	Percentage of aesthetic, functional and biological properties were clinically assessed using World Dental Federation parameters for each base material group
Percentage of patients with periodontal problems	3 years after restoration	The periodontal situation of patients were examined based on bleeding on probing, plaque index and probing depth scores

Secondary Outcome Measures

Name	Time	Method
Radiographic examination	3 years after restoration	Each base material/gingival dentin interface was examined radiographically each 6 months period.

Trial Locations

Locations (1)

Faculty of Dentistry-Mansoura University; 🇪🇬 Mansoura, Dakahliya, Egypt