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Not yet recruiting NCT06606379

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

No phase Interventional Proximal Caries

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: I1 (Intervention), I2 (Intervention), I3 (Intervention), C (comparator).
Who it may be relevant to
Registry conditions: Proximal Caries. Basic parameters: 25 years — 40 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • 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)

Primary outcome measures

  • Proximal Contact tightness (Success rate) [Time frame: From enrollment to the end of treatment at 6 months]
Secondary outcome measures (3)
  • Form and Contour [Time frame: From enrollment to the end of treatment at 6 months]
  • Patient Comfort [Time frame: From enrollment to the end of treatment at 6 months]
  • Emergence profile [Time frame: From enrollment to the end of treatment at 6 months]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06606379 · IMPACT OF SEPARATION METHODS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗