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

Not Applicable

Not yet recruiting

• Conditions: Proximal Caries
• Interventions: Device: C (comparator); Device: I1 (Intervention); Device: I2 (Intervention); Device: I3 (Intervention)

• Registration Number: NCT06606379
• Lead Sponsor: Cairo University

Brief 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.

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-09-18
• Study First Submitted QC: 2024-09-18
• Last Update Submitted: 2024-09-18
• Study First Posted: 2024-09-23
• Last Update Posted: 2024-09-23
• Study Start: 2025-01-01
• Primary Completion: 2025-06-30
• Study Completion: 2026-01-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

1. Individuals with posterior compound proximal carious cavities in molars.
2. Age of (25-40) years.
3. Molars with compound proximal carious cavities score 4 or 5 ICDS.
4. Vital upper or lower posterior teeth with no signs of irreversible pulpitis.
5. Presence of adjacent and opposing teeth with normal occlusion

Exclusion Criteria

1. Patients with major systemic disorders or xerostomia.
2. Patients with periodontal disease.
3. Patients with para-functional habits.
4. Presence of malocclusion or signs of pathological teeth wear
5. Non vital teeth or teeth with signs of pulpal pathology.
6. Teeth mobility or clinical attachment loss.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Proximal Contact tightness (Success rate)	From enrollment to the end of treatment at 6 months	Visual examination and 25-/50-/100-µm blade according to FDI Criteria

Secondary Outcome Measures

Name	Time	Method
Form and Contour	From enrollment to the end of treatment at 6 months	Visual examination according to FDI Criteria
Patient Comfort	From enrollment to the end of treatment at 6 months	Pain rating scale
Emergence profile	From enrollment to the end of treatment at 6 months	Bitewing Radiographs