Clinical trial NCT04861285: Gingival Displacement With RACESTYPTINE Solution and RACEGEL: a Prospective, Comparative Randomized Clinical Trial.
Official title: Evaluation of Gingival Displacement With RACESTYPTINE Solution and RACEGEL: a Prospective, Comparative Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gingival Retraction Techniques
Keywords: gingival retraction, dental impression
Lead sponsor: Septodont
Sponsor class: INDUSTRY
Collaborators: name: Slb Pharma
name: Rennes University Hospital
First posted: 2021-04-27
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Study subject (tooth) will be randomized in a 1:1:1 allocation ratio between the 3 gingival retraction techniques.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Quantitative assessment of the lateral gingival displacement
timeFrame: Day 0
Secondary outcomes:
measure: Quantitative assessment of the vertical gingival displacement
timeFrame: Day 0
measure: Oozing control assessment
timeFrame: Day 0
measure: Bleeding control assessment
timeFrame: Day 0
measure: Gingival index
timeFrame: Day 0 (before and after the gingival retraction), Day 14 (end of study visit)
measure: Papilla Bleeding index
timeFrame: Day 0 (before and after the gingival retraction), Day 14 (end of study visit)
measure: Probing depth
timeFrame: Day 0 (before and after the gingival retraction), Day 14 (end of study visit)
measure: Adverse events
timeFrame: Day 0, Day 14 (end of study visit)
Other outcomes:
Locations:
city: Cesson-Sévigné
country: France
facility: Cabinet dentaire
city: Rennes
country: France
facility: Cabinet dentaire Dr Rubin
city: Rennes
country: France
facility: Cabinet dentaire Magister
city: Rennes
country: France
facility: Cabinet dentaire
city: Tinteniac
country: France
facility: Cabinet dentaire - Médipole 35
Study officials:
affiliation: Cabinet dentaire (Rennes)
name: Hugues Colombel, DDS
role: PRINCIPAL_INVESTIGATOR
References: