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The aim of this study is to evaluate the interdental separation of various separation systems and their impact on the proximal contact tightness and contour in compound class II nanohybrid resin composite restorations.
The target population consists of adult patients aged 25-40, with posterior compound proximal carious cavities (ICDS score 4 or 5) in molars. The interventions under investigation include three different separation systems: the Resin ring (DR-Resin ring, Egypt), Elliot separator (Pfingst & Co, USA), and Stainless Steel Metal ring (TOR VM ring, Russia). These systems will be compared to a Nickel titanium 3D-fusion ring (Garrison, USA). The primary outcomes assessed are proximal contact tightness and form/contour, measured visually according to FDI criteria, with scoring systems adapted from Hickel et al. (2023). Secondary outcomes, such as patient comfort (measured by a pain rating scale), and the emergence profile (assessed via bitewing radiographs), will also be considered. Data will be collected immediately postoperatively (T0), at 30 days (T1), and after 6 months (T2). The study will be conducted as a randomized clinical trial. The null hypothesis suggests that there will be no significant differences in proximal contact tightness or contour across the different separation systems used.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| C (comparator) | Active Comparator | Nickel titanium 3D-fusion ring (Garrison, USA) |
|
| I1 (Intervention) | Experimental | Resin ring (DR- Resin ring, Egypt) |
|
| I2 (Intervention) | Experimental | Elliot separator (Pfingst & Co, South Plainfield, NJ, USA) |
|
| I3 (Intervention) | Experimental | Stainless Steel Metal ring (TOR VM ring, Moscow, Russia) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| I1 (Intervention) | Device | Resin ring (DR- Resin ring, Egypt) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Proximal Contact tightness (Success rate) | Visual examination and 25-/50-/100-µm blade according to FDI Criteria | From enrollment to the end of treatment at 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Form and Contour | Visual examination according to FDI Criteria | From enrollment to the end of treatment at 6 months |
| Patient Comfort | Pain rating scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hadeer H Mohamed, MSC. degree | Contact | +20 1015779373 | hadeer.hesham@dentistry.cu.edu.eg | |
| Omnia A Amin, MSC. degree | Contact | +20 1272512839 | omnia.abdellatif@dentistry.cu.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Hadeer H Mohamed, MSC. degree | Assistant Lecturer of Conservative Dentistry, Faculty of Dentistry Cairo University, Egypt. | Principal Investigator |
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| ID | Term |
|---|---|
| D008722 | Methods |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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| I2 (Intervention) |
| Device |
Elliot separator (Pfingst & Co, South Plainfield, NJ, USA) |
|
| I3 (Intervention) | Device | Stainless Steel Metal ring (TOR VM ring, Moscow, Russia) |
|
| C (comparator) | Device | Nickel titanium 3D-fusion ring (Garrison, USA) |
|
| From enrollment to the end of treatment at 6 months |
| Emergence profile | Bitewing Radiographs | From enrollment to the end of treatment at 6 months |