Clinical trial NCT05125900: Clinical Evaluation of Subgingival Open Sandwich Restorations
Official title: Clinical Evaluation of Subgingival Open Sandwich Restorations: 3-year Results of a Randomized Double-blind Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Restoration Failure of Marginal Integrity
Keywords: Deep margin elevation
Proximal box elevation
Open sandwich technique
Bi-layered restorations
Subgingival cervical margin
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2021-11-18
Enrollment: 95
Sex: ALL
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Each patient received one or two restorations in a posterior tooth on any side randomly selected from the 4 tested restorative materials, all materials were used according to manufacturers' instructions
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of patients with periodontal problems
timeFrame: 3 years after restoration
measure: Percentage of aesthetic, functional and biological properties for each base material restorations
timeFrame: 3 years after restoration
Secondary outcomes:
measure: Radiographic examination
timeFrame: 3 years after restoration
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Faculty of Dentistry-Mansoura University
state: Dakahliya
Study officials:
affiliation: Faculty of Dentistry, Mansoura University, Egypt
name: Hoda S Ismail, Lecturer
role: PRINCIPAL_INVESTIGATOR
References: