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Clinical Trial 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 clinical performance and safety data from RACEGEL and RACESTYPTINE Solution. Three gingival retraction techniques are being studied: RACESTYPTINE Solution with cord, RACEGEL with cord and RACEGEL without cord. The study will demonstrate the expected performance of these 3 techniques in terms of sulcus opening, i.e. a lateral gingival displacement of at least 200 µm (state of the art) allowing the realization of pre-prosthetic impression with subgingivally margins. 90 subjects (teeth) requiring a dental restoration with subgingival margins for placement of a fixed prosthesis will be enrolled in 3 groups (30 in each group). For each participant, two dental impressions are performed: one impression before the gingival retraction and one impression immediately after the gingival retraction. Both impressions are scanned with 3D dental scanner and images are superimposed before analysis of tissue displacement.

Clinical Trial Description


Study Design

Related Conditions & MeSH terms

NCT number NCT04861285
Study type Interventional
Source Septodont
Contact Anne-Laure Sérandour, PhD
Phone +33 (0)299121962
Email [email protected]
Status Not yet recruiting
Phase N/A
Start date April 28, 2021
Completion date October 31, 2021

See also
  Status Clinical Trial Phase
Completed NCT02716727 - Comparison of Two Gingival Displacement Procedures N/A