NCT06606379

Impact of Different Separation Methods on Proximal Contact Tightness and Contour of Compound Class ii

Impact of Different Separation Methods on Proximal Contact Tightness and Contour of Compound Class ii Nanohybrid Resin Composite Restorations: Randomized Clinical Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: Cairo University · Academic / Other
• Sex: All
• Age: 25 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Proximal Caries

Interventions

Type	Name	Description
DEVICE	I1 (Intervention)	Resin ring (DR- Resin ring, Egypt)
DEVICE	I2 (Intervention)	Elliot separator (Pfingst \& Co, South Plainfield, NJ, USA)
DEVICE	I3 (Intervention)	Stainless Steel Metal ring (TOR VM ring, Moscow, Russia)
DEVICE	C (comparator)	Nickel titanium 3D-fusion ring (Garrison, USA)

Timeline

• Start date: 2025-01-01
• Primary completion: 2025-06-30
• Completion: 2026-01-01
• First posted: 2024-09-23
• Last updated: 2024-09-23