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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06606379
Enrollment
160
Registered
2024-09-23
Start date
2025-01-01
Completion date
2026-01-01
Last updated
2024-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Proximal Caries

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.

Interventions

DEVICEI1 (Intervention)

Resin ring (DR- Resin ring, Egypt)

DEVICEI2 (Intervention)

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

DEVICEI3 (Intervention)

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

DEVICEC (comparator)

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

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
25 Years to 40 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Proximal Contact tightness (Success rate)From enrollment to the end of treatment at 6 monthsVisual examination and 25-/50-/100-µm blade according to FDI Criteria

Secondary

MeasureTime frameDescription
Form and ContourFrom enrollment to the end of treatment at 6 monthsVisual examination according to FDI Criteria
Patient ComfortFrom enrollment to the end of treatment at 6 monthsPain rating scale
Emergence profileFrom enrollment to the end of treatment at 6 monthsBitewing Radiographs

Contacts

Primary ContactHadeer H Mohamed, MSC. degree
hadeer.hesham@dentistry.cu.edu.eg+20 1015779373
Backup ContactOmnia A Amin, MSC. degree
omnia.abdellatif@dentistry.cu.edu.eg+20 1272512839

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026