Impact of Different Separation Methods on Proximal Contact Tightness and Contour of Compound Class ii
1 other identifier
interventional
160
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2025
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 18, 2024
CompletedFirst Posted
Study publicly available on registry
September 23, 2024
CompletedStudy Start
First participant enrolled
January 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2026
CompletedSeptember 23, 2024
September 1, 2024
6 months
September 18, 2024
September 18, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Form and Contour
From enrollment to the end of treatment at 6 months
Patient Comfort
From enrollment to the end of treatment at 6 months
Emergence profile
From enrollment to the end of treatment at 6 months
Study Arms (4)
C (comparator)
ACTIVE COMPARATORNickel titanium 3D-fusion ring (Garrison, USA)
I1 (Intervention)
EXPERIMENTALResin ring (DR- Resin ring, Egypt)
I2 (Intervention)
EXPERIMENTALElliot separator (Pfingst \& Co, South Plainfield, NJ, USA)
I3 (Intervention)
EXPERIMENTALStainless Steel Metal ring (TOR VM ring, Moscow, Russia)
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hadeer H Mohamed, MSC. degree
Assistant Lecturer of Conservative Dentistry, Faculty of Dentistry Cairo University, Egypt.
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr. Hadeer Hesham
Study Record Dates
First Submitted
September 18, 2024
First Posted
September 23, 2024
Study Start
January 1, 2025
Primary Completion
June 30, 2025
Study Completion
January 1, 2026
Last Updated
September 23, 2024
Record last verified: 2024-09