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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Proximal Caries
• Intervention / Treatment: Device: C (comparator); Device: I1 (Intervention); Device: I2 (Intervention); Device: I3 (Intervention)

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 Type: Interventional
• Enrollment (Estimated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hadeer H Mohamed, MSC. degree; Phone Number: +20 1015779373; Email: hadeer.hesham@dentistry.cu.edu.eg
• Study Contact Backup: Name: Omnia A Amin, MSC. degree; Phone Number: +20 1272512839; Email: omnia.abdellatif@dentistry.cu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: C (comparator); Nickel titanium 3D-fusion ring (Garrison, USA)	Device: C (comparator); Nickel titanium 3D-fusion ring (Garrison, USA)
Experimental: I1 (Intervention); Resin ring (DR- Resin ring, Egypt)	Device: I1 (Intervention); Resin ring (DR- Resin ring, Egypt)
Experimental: I2 (Intervention); Elliot separator (Pfingst & Co, South Plainfield, NJ, USA)	Device: I2 (Intervention); Elliot separator (Pfingst & Co, South Plainfield, NJ, USA)
Experimental: I3 (Intervention); Stainless Steel Metal ring (TOR VM ring, Moscow, Russia)	Device: I3 (Intervention); Stainless Steel Metal ring (TOR VM ring, Moscow, Russia)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Hadeer H Mohamed, MSC. degree, Assistant Lecturer of Conservative Dentistry, Faculty of Dentistry Cairo University, Egypt.

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2025
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: September 18, 2024
• First Submitted That Met QC Criteria: September 18, 2024
• First Posted (Actual): September 23, 2024

Study Record Updates

• Last Update Posted (Actual): September 23, 2024
• Last Update Submitted That Met QC Criteria: September 18, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: IMPACT OF SEPARATION METHODS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No