Clinical Evaluation of Subgingival Open Sandwich Restorations

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

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.

Study Overview

• Status: Completed
• Conditions: Dental Restoration Failure of Marginal Integrity
• Intervention / Treatment: Other: Proximal box elevation using one of the tested materials

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.

• Study Type: Interventional
• Enrollment (Actual): 95
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Dakahliya
    • Mansoura, Dakahliya, Egypt, 35516
      • Faculty of Dentistry-Mansoura University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Resin modified glass ionomer; Group received proximal box elevation using resin modified glass ionomer	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
Placebo Comparator: Glass hybrid; Group received proximal box elevation using glass hybrid	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
Active Comparator: Bulk fill flowable resin composite; Group received proximal box elevation using bulk fill flowable resin composite	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
Placebo Comparator: Ion-releasing material; Group received proximal box elevation using ion-releasing material	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiographic examination	Each base material/gingival dentin interface was examined radiographically each 6 months period.	3 years after restoration

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: Principal Investigator: Hoda S Ismail, Lecturer, Faculty of Dentistry, Mansoura University, Egypt

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Actual): January 1, 2022
• Study Completion (Actual): January 1, 2023

Study Registration Dates

• First Submitted: November 8, 2021
• First Submitted That Met QC Criteria: November 8, 2021
• First Posted (Actual): November 18, 2021

Study Record Updates

• Last Update Posted (Actual): July 14, 2023
• Last Update Submitted That Met QC Criteria: July 12, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Deep margin elevation; Proximal box elevation; Open sandwich technique; Bi-layered restorations; Subgingival cervical margin
• Other Study ID Numbers: A01111219

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Study Protocol, Statistical Analysis Plan can be shared to other researchers
• IPD Sharing Time Frame: Data will be available within 6 Months for 3 years
• IPD Sharing Access Criteria: for anyone
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes