Ignite Creation Date:
2024-10-25 @ 7:54 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06606379
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-18
Brief Title:
Impact of Different Separation Methods on Proximal Contact Tightness and Contour of Compound Class ii
Sponsor:
None
Organization:
None
Study Overview
Official Title:
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
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 amp 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 formcontour 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None