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

NCT04861285 | Completed

• 2 other identifiers: RETRACT2021-A00179-32
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 5

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 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

Keywords

gingival retraction, dental impression

Outcome Measures

Primary Outcomes (1)

• Quantitative assessment of the lateral gingival displacement

  Two dental impressions are performed per participant at the same visit : 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 analyses. The lateral gingival displacement corresponds to the difference between pre- and post-displacement sulcus width measured in the 2 superimposed images of the pre- and post-retraction scanned models.

  Day 0

Secondary Outcomes (7)

• Quantitative assessment of the vertical gingival displacement

  Day 0

• Oozing control assessment

  Day 0

• Bleeding control assessment

  Day 0

• Gingival index

  Day 0 (before and after the gingival retraction), Day 14 (end of study visit)

• Papilla Bleeding index

  Day 0 (before and after the gingival retraction), Day 14 (end of study visit)

Study Arms (3)

RACESTYPTINE Solution with cord

EXPERIMENTAL

The participant will receive RACESTYPTINE Solution into the sulcus. The solution is used in combination with a non-medicated gingival retraction cord.

Device: RACESTYPTINE Solution with cord

RACEGEL with cord

EXPERIMENTAL

The participant will receive RACEGEL into the sulcus. The gel is used in combination with a non-medicated gingival retraction cord.

Device: RACEGEL with cord

RACEGEL without cord

EXPERIMENTAL

The participant will receive RACEGEL into the sulcus. No cord will be added.

Device: RACEGEL without cord

Interventions

RACESTYPTINE Solution with cord DEVICE

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.

RACESTYPTINE Solution with cord

RACEGEL with cord DEVICE

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.

RACEGEL with cord

RACEGEL without cord DEVICE

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.

RACEGEL without cord

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Septodont: lead
• Slb Pharma: collaborator
• Rennes University Hospital: collaborator

Study Sites (5)

Cabinet dentaire

Cesson-Sévigné, 35510, France

Location

Cabinet dentaire Dr Rubin

Rennes, 35000, France

Location

Cabinet dentaire Magister

Rennes, 35000, France

Location

Cabinet dentaire

Rennes, 35000, France

Location

Cabinet dentaire - Médipole 35

Tinténiac, 35190, France

Location

Study Officials

• Hugues Colombel, DDS

  Cabinet dentaire (Rennes)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Blinding will be done to the assessors who analyzed dental impression to reduce bias to gingival tissue displacement assessment
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Study subject (tooth) will be randomized in a 1:1:1 allocation ratio between the 3 gingival retraction techniques.

Study Record Dates

• First Submitted: April 23, 2021
• First Posted: April 27, 2021
• Study Start: May 10, 2021
• Primary Completion: November 5, 2021
• Study Completion: November 12, 2021
• Last Updated: November 29, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (5)