Dental Restoration Failure of Marginal Integrity
Conditions
Keywords
Deep margin elevation, Proximal box elevation, Open sandwich technique, Bi-layered restorations, Subgingival cervical margin
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.
Interventions
OTHERProximal 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
Sponsors
Mansoura University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Double (Participant and Investigator)
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
Eligibility
Sex/Gender
ALL
Age
21 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Radiographic examination | 3 years after restoration | Each base material/gingival dentin interface was examined radiographically each 6 months period. |
Countries
Egypt
Outcome results
None listed