Deep Margin Elevation With Different Restorative Materials in Class II Resin Composite
Study Details
Study Description
Brief Summary
This study was designed to evaluate and compare the 2-year clinical performance of resin composite restorations in class II cavities with deep sub-gingival margins relocated using three different glass ionomer based restorative materials and flowable composite, based on FDI criteria.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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. One hundred and twenty adult patients seeking dental treatment in Operative Department clinic at 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 much sign a consent form before participating in the current study. The study was conducted from January 2020 to January 2022 as a part of 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. Allowing for a 20% drop-out, sample size was set totalizing 120 subjects.
Study Design
Arms and Interventions
| 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: Bioactive restorative material Group received proximal box elevation using Bioactive restorative 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
|
Outcome Measures
Primary Outcome Measures
- Percentage of patients with periodontal problems [2 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 [2 years after restoration]
Percentage of aesthetic, functional and biological properties were clinically assessed using World Dental Federation parameters for each base material group
Secondary Outcome Measures
- Radio graphic examination [2 years after restoration]
Each base material/gingival dentin interface was examined radio graphically each 6 months period.
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Faculty of Dentistry-Mansoura University | Mansoura | Dakahliya | Egypt | 35516 |
Sponsors and Collaborators
- Mansoura University
Investigators
- Principal Investigator: Hoda S Ismail, Assis.Lec, Faculty of Dentistry, Mansoura University, Egypt
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- A01111219