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

Septodont

Status: Completed

Conditions: Gingival Retraction Techniques

Treatments: Device: RACEGEL with cord; Device: RACEGEL without cord; Device: RACESTYPTINE Solution with cord

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04861285

2021-A00179-32 (Other Identifier)

RETRACT

Details and patient eligibility

About

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.

Enrollment: 88 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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88 participants in 3 patient groups

RACESTYPTINE Solution with cord

Experimental group

Description:

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

Treatment:

Device: RACESTYPTINE Solution with cord

RACEGEL with cord

Experimental group

Description:

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

Treatment:

Device: RACEGEL with cord

RACEGEL without cord

Experimental group

Description:

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

Treatment:

Device: RACEGEL without cord