I1 (Intervention)
DeviceResin ring (DR- Resin ring, Egypt)
NCT Number: NCT06606379
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 opening soon.
Get Notified25 year–40 year
All sexes
Interventional
Not applicable
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Resin ring (DR- Resin ring, Egypt)
Elliot separator (Pfingst & Co, South Plainfield, NJ, USA)
Stainless Steel Metal ring (TOR VM ring, Moscow, Russia)
Nickel titanium 3D-fusion ring (Garrison, USA)
Time frame: From enrollment to the end of treatment at 6 months
Visual examination and 25-/50-/100-µm blade according to FDI Criteria
Time frame: From enrollment to the end of treatment at 6 months
Visual examination according to FDI Criteria
Time frame: From enrollment to the end of treatment at 6 months
Pain rating scale
Time frame: From enrollment to the end of treatment at 6 months
Bitewing Radiographs
Contact information is provided by the study sponsor or research team.
Hadeer H Mohamed, MSC. degree
CONTACT
Omnia A Amin, MSC. degree
CONTACT
Cairo University
Other
Impact of Different Separation Methods on Proximal Contact Tightness and Contour of Compound Class ii Nanohybrid Resin Composite Restorations: Randomized Clinical Trial
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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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