An interventional study of I1 (Intervention) and I2 (Intervention) in Proximal Caries, sponsored by Cairo University. Not yet recruiting. Open to participants aged 25 Years to 40 Years. Per ClinicalTrials.gov, last updated 2024-09-23.
Sponsored by Cairo University · Not applicable, Interventional, and Treatment
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.
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.
Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.
Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Nickel titanium 3D-fusion ring (Garrison, USA)
Device: C (comparator)
Resin ring (DR- Resin ring, Egypt)
Device: I1 (Intervention)
Elliot separator (Pfingst \& Co, South Plainfield, NJ, USA)
Device: I2 (Intervention)
Stainless Steel Metal ring (TOR VM ring, Moscow, Russia)
Device: I3 (Intervention)
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)
Proximal Contact tightness (Success rate)
Visual examination and 25-/50-/100-µm blade according to FDI Criteria
Time frame: From enrollment to the end of treatment at 6 months
Form and Contour
Visual examination according to FDI Criteria
Time frame: From enrollment to the end of treatment at 6 months
Patient Comfort
Pain rating scale
Time frame: From enrollment to the end of treatment at 6 months
Emergence profile
Bitewing Radiographs
Time frame: From enrollment to the end of treatment at 6 months
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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Cairo University