Gingival Displacement With RACESTYPTINE Solution and RACEGEL: a Prospective, Comparative Randomized Clinical Trial.
NCT ID: NCT04861285
Last Updated: 2021-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
88 participants
INTERVENTIONAL
2021-05-10
2021-11-12
Brief Summary
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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
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
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.
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 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.
RACEGEL without cord
The participant will receive RACEGEL into the sulcus. No cord will be added.
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.
Interventions
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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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Slb Pharma
OTHER
Rennes University Hospital
OTHER
Septodont
INDUSTRY
Responsible Party
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Principal Investigators
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Hugues Colombel, DDS
Role: PRINCIPAL_INVESTIGATOR
Cabinet dentaire (Rennes)
Locations
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Cabinet dentaire
Cesson-Sévigné, , France
Cabinet dentaire Dr Rubin
Rennes, , France
Cabinet dentaire Magister
Rennes, , France
Cabinet dentaire
Rennes, , France
Cabinet dentaire - Médipole 35
Tinténiac, , France
Countries
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Other Identifiers
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2021-A00179-32
Identifier Type: OTHER
Identifier Source: secondary_id
RETRACT
Identifier Type: -
Identifier Source: org_study_id