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NCT Number: NCT06606379

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

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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Key information

Conditions

Age range

25 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

I1 (Intervention)

Device

Resin ring (DR- Resin ring, Egypt)

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)

Primary outcomes

  1. Proximal Contact tightness (Success rate)

    Time frame: From enrollment to the end of treatment at 6 months

    Visual examination and 25-/50-/100-µm blade according to FDI Criteria

Secondary outcomes

  1. Form and Contour

    Time frame: From enrollment to the end of treatment at 6 months

    Visual examination according to FDI Criteria

  2. Patient Comfort

    Time frame: From enrollment to the end of treatment at 6 months

    Pain rating scale

  3. Emergence profile

    Time frame: From enrollment to the end of treatment at 6 months

    Bitewing Radiographs

Study contacts

Contact information is provided by the study sponsor or research team.

Hadeer H Mohamed, MSC. degree

CONTACT

[email protected]

+20 1015779373

Omnia A Amin, MSC. degree

CONTACT

[email protected]

+20 1272512839

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Sep 23, 2024
Registry last updated
Sep 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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