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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-01

Study Completion Date

2026-01-01

Brief Summary

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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.

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Detailed Description

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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

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Proximal Caries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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C (comparator)

Nickel titanium 3D-fusion ring (Garrison, USA)

Group Type ACTIVE_COMPARATOR

C (comparator)

Intervention Type DEVICE

Nickel titanium 3D-fusion ring (Garrison, USA)

I1 (Intervention)

Resin ring (DR- Resin ring, Egypt)

Group Type EXPERIMENTAL

I1 (Intervention)

Intervention Type DEVICE

Resin ring (DR- Resin ring, Egypt)

I2 (Intervention)

Elliot separator (Pfingst \& Co, South Plainfield, NJ, USA)

Group Type EXPERIMENTAL

I2 (Intervention)

Intervention Type DEVICE

Elliot separator (Pfingst \& Co, South Plainfield, NJ, USA)

I3 (Intervention)

Stainless Steel Metal ring (TOR VM ring, Moscow, Russia)

Group Type EXPERIMENTAL

I3 (Intervention)

Intervention Type DEVICE

Stainless Steel Metal ring (TOR VM ring, Moscow, Russia)

Interventions

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I1 (Intervention)

Resin ring (DR- Resin ring, Egypt)

Intervention Type DEVICE

I2 (Intervention)

Elliot separator (Pfingst \& Co, South Plainfield, NJ, USA)

Intervention Type DEVICE

I3 (Intervention)

Stainless Steel Metal ring (TOR VM ring, Moscow, Russia)

Intervention Type DEVICE

C (comparator)

Nickel titanium 3D-fusion ring (Garrison, USA)

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

25 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No