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

Not Applicable

Completed

• Conditions: Gingival Retraction Techniques
• Interventions: Device: RACESTYPTINE Solution with cord; Device: RACEGEL with cord; Device: RACEGEL without cord

• Registration Number: NCT04861285
• Lead Sponsor: Septodont

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-04-23
• Study First Submitted QC: 2021-04-23
• Study First Posted: 2021-04-27
• Study Start: 2021-05-10
• Status Verified: 2021-06
• Primary Completion: 2021-11-05
• Study Completion: 2021-11-12
• Last Update Submitted: 2021-11-26
• Last Update Posted: 2021-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RACESTYPTINE Solution with cord	RACESTYPTINE Solution with cord	The participant will receive RACESTYPTINE Solution into the sulcus. The solution is used in combination with a non-medicated gingival retraction cord.
RACEGEL with cord	RACEGEL with cord	The participant will receive RACEGEL into the sulcus. The gel is used in combination with a non-medicated gingival retraction cord.
RACEGEL without cord	RACEGEL without cord	The participant will receive RACEGEL into the sulcus. No cord will be added.

Primary Outcome Measures

Name	Time	Method
Quantitative assessment of the lateral gingival displacement	Day 0	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.

Secondary Outcome Measures

Name	Time	Method
Papilla Bleeding index	Day 0 (before and after the gingival retraction), Day 14 (end of study visit)	The Papilla Bleeding Index assesses gingival inflammation in the interdental papillae by recording bleeding on probing in the interdental areas. A periodontal probe is passed along the gingival margin to provoke bleeding and clinical findings are recorded according the following criteria: Grade 0 = No bleeding on probing. Grade 1 = isolated bleeding spots present. Grade 2 = blood forms a red line on gingival margin. Grade 3 = heavy profuse bleeding.
Probing depth	Day 0 (before and after the gingival retraction), Day 14 (end of study visit)	The probing depth measures the distance (in mm) from the free end of the gingival margin to the bottom of the periodontal pocket with a calibrated periodontal probe. A healthy periodontium and gingiva has a probing depth ≤3 mm. A probing depth \>3 mm is pathologic.
Quantitative assessment of the vertical gingival displacement	Day 0	The vertical gingival displacement corresponds to the greatest vertical distance between the crest of the gingiva in the 2 superimposed images of the pre- and post-retraction scanned models.
Oozing control assessment	Day 0	The dentist visually assesses the presence or absence of crevicular fluid in the sulcus immediately after removing the retraction material.
Gingival index	Day 0 (before and after the gingival retraction), Day 14 (end of study visit)	The Gingival Index records gingival inflammation on the prepared tooth in 3 grades according the following criteria: Grade 0 = Normal gingiva. Grade 1 = Mild inflammation - slight change in color, slight edema. No bleeding on probing.; Grade 2 = Moderate inflammation - redness, edema, glazing. Bleeding on probing. Grade 3 = Severe inflammation - marked redness and edema, ulceration. Tendency toward spontaneous bleeding.
Bleeding control assessment	Day 0	The dentist visually assesses the stop of gingival bleeding (if there was one prior to the gingival retraction step), immediately after removing the retraction material.
Adverse events	Day 0, Day 14 (end of study visit)	Adverse events clinically observed by the dentist during the gingival retraction and impression procedures (Day 0) and at the end of study visit (Day 14) will be used to assess the safety.

Trial Locations

Locations (4)

Cabinet dentaire - Médipole 35; 🇫🇷 Tinteniac, France

Cabinet dentaire; 🇫🇷 Rennes, France

Cabinet dentaire Dr Rubin; 🇫🇷 Rennes, France

Cabinet dentaire Magister; 🇫🇷 Rennes, France