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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Resin modified glass ionomer | Active Comparator | Group received proximal box elevation using resin modified glass ionomer |
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| Glass hybrid | Placebo Comparator | Group received proximal box elevation using glass hybrid |
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| Bulk fill flowable resin composite | Active Comparator | Group received proximal box elevation using bulk fill flowable resin composite |
|
| Ion-releasing material | Placebo Comparator | Group received proximal box elevation using ion-releasing material |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Proximal box elevation using one of the tested materials | Other | 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Radiographic examination | Each base material/gingival dentin interface was examined radiographically each 6 months period. | 3 years after restoration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hoda S Ismail, Lecturer | Faculty of Dentistry, Mansoura University, Egypt | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dentistry-Mansoura University | Al Mansurah | Dakahliya | 35516 | Egypt |
Study Protocol, Statistical Analysis Plan can be shared to other researchers
Data will be available within 6 Months for 3 years
for anyone
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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
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Double (Participant and Investigator)