Gingival Displacement With RACESTYPTINE Solution and RACEGEL: a Prospective, Comparative Randomized 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.

Conditions

• Gingival Retraction Techniques

Interventions

DEVICE

RACESTYPTINE Solution with cord

The dentist inserts a non-medicated gingival retraction cord into the sulcus and then impregnates the cord in situ with a few drops of RACESTYPTINE Solution. The impregnated cord is left in place a few minutes and then removed. The gingival sulcus is washed and gently air-dried before taking impression.

DEVICE

RACEGEL with cord

The dentist applies a sufficient amount of RACEGEL directly into the sulcus, following the contour of the prepared tooth, and then inserts a non-medicated gingival retraction cord into the sulcus. The impregnated cord is left in place a few minutes and then removed. The sulcus is washed and gently air-dried before taking impression.

DEVICE

RACEGEL without cord

The dentist applies a sufficient amount of RACEGEL directly into the sulcus, following the contour of the prepared tooth. The gel is left in place a few minutes and then removed. The sulcus is washed and gently air-dried before taking impression.

Sponsors & Collaborators

• Slb Pharma

  collaborator OTHER

• Rennes University Hospital

  collaborator OTHER

• Septodont

  lead INDUSTRY

Principal Investigators

• Hugues Colombel, DDS · Cabinet dentaire (Rennes)

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-05-10

Primary Completion

2021-11-05

Completion

2021-11-12

Countries

• France

Study Locations