Status:
COMPLETED
Gingival Displacement With RACESTYPTINE Solution and RACEGEL: a Prospective, Comparative Randomized Clinical Trial.
Lead Sponsor:
Septodont
Collaborating Sponsors:
Slb Pharma
Rennes University Hospital
Conditions:
Gingival Retraction Techniques
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The study design is a prospective, multi-center randomized, controlled, open label, 3-arm parallel group, post market clinical follow-up (PMCF) Clinical Trial. The aim of the study is to collect clin...
Eligibility Criteria
Inclusion
- Adult male or female (age ≥18 years),
- Patient requiring a dental restoration with subgingival margins on one or more teeth with placement of a single or multiple fixed prosthesis. Partially edentulous patients can be enrolled.
- Good oral hygiene
- Healthy periodontium and gingiva: probing depth ≤3 mm, no evidence of gingival inflammation (gingival index ≤ 1), attachment loss (attached gingival \>2 mm), bleeding on probing, or plaque accumulation (plaque index \< 3)
- Patient who received information and gave written consent.
- Patient affiliated with a social security/protection plan.
Exclusion
- Contraindication to taking impression evidenced at the latest on the day of inclusion visit (gingival index ≥2, sign of attachment loss or tooth mobility, probing depth \>3 mm).
- Known allergy to aluminum, aluminum salts or to one of the compounds of the formula of the gingival retraction material, or to one of the compounds of the impression material.
- Patient with an unbalanced systemic disease (diabetes, thyroid disorders, history of oropharyngeal cancer),
- Simultaneous participation in another interventional clinical investigation or trial,
- Vulnerable Subjects
Key Trial Info
Start Date :
May 10 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 12 2021
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT04861285
Start Date
May 10 2021
End Date
November 12 2021
Last Update
November 29 2021
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
Cabinet dentaire
Cesson-Sévigné, France, 35510
2
Cabinet dentaire Dr Rubin
Rennes, France, 35000
3
Cabinet dentaire Magister
Rennes, France, 35000
4
Cabinet dentaire
Rennes, France, 35000