Gingival Retraction TechniquesRETRACTNCT04861285
Gingival Displacement With RACESTYPTINE Solution and RACEGEL: a Prospective, Comparative Randomized Clinical Trial.
A study testing RACESTYPTINE Solution with cord, RACEGEL with cord and RACEGEL without cord in people with Gingival Retraction Techniques, run by Septodont at 5 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gingival Retraction Techniques
- What is being tested?
- RACESTYPTINE Solution with cord, RACEGEL with cord and RACEGEL without cord
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 5 sitesFrance
- Study dates
- 10 May 2021to 12 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
Cabinet dentaire
Cesson-Sévigné, 35510
Cabinet dentaire Dr Rubin
Rennes, 35000
Cabinet dentaire Magister
Rennes, 35000
Cabinet dentaire
Rennes, 35000
Cabinet dentaire - Médipole 35
Tinténiac, 35190
About this study
Official title: Evaluation of Gingival Displacement With RACESTYPTINE Solution and RACEGEL: a Prospective, Comparative Randomized Clinical Trial.
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
- Being tested
- RACESTYPTINE Solution with cord, RACEGEL with cord, RACEGEL without cord
- Keywords
- gingival retraction, dental impression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RACESTYPTINE Solution with cordDevice
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 cordDevice
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 cordDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: RACEGEL with cord |
| RACEGEL without cord | Experimental | The participant will receive RACEGEL into the sulcus. No cord will be added. Receives: Device: RACEGEL without cord |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 0
Secondary outcomes (7)
Quantitative assessment of the vertical gingival displacement
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.
Measured: Day 0
Oozing control assessment
The dentist visually assesses the presence or absence of crevicular fluid in the sulcus immediately after removing the retraction material.
Measured: Day 0
Bleeding control assessment
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.
Measured: Day 0
Gingival index
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.
Measured: Day 0 (before and after the gingival retraction), Day 14 (end of study visit)
Papilla Bleeding index
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.
Measured: Day 0 (before and after the gingival retraction), Day 14 (end of study visit)
Probing depth
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.
Measured: Day 0 (before and after the gingival retraction), Day 14 (end of study visit)
Adverse events
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.
Measured: Day 0, Day 14 (end of study visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2021
- Study start10 May 2021
- Primary completion5 Nov 2021
- Study completion12 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingival Retraction TechniquesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Study subject (tooth) will be randomized in a 1:1:1 allocation ratio between the 3 gingival retraction techniques.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Septodont
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Slb Pharma, Rennes University Hospital
- Responsible party
- Sponsor
- Investigators
- Hugues Colombel, DDS, Principal investigator, Cabinet dentaire (Rennes)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04861285
- Sponsor's protocol ID
- RETRACT
- Other IDs
- 2021-A00179-32
- Acronym
- RETRACT
- Status last verified
- Jun 2021
- First submitted
- 23 Apr 2021
- Last updated
- 29 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Gingival Displacement With RACESTYPTINE Solution and RACEGEL: a Prospective, Comparative Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT04861285
- Acronym / sponsor ID
- RETRACT / RETRACT
- Conditions
- Gingival Retraction Techniques
- Keywords
- gingival retraction, dental impression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- SeptodontIndustry (pharma, biotech, devices)
- Collaborators
- Slb Pharma, Rennes University Hospital
- Study start
- 10 May 2021 (actual)
- Primary completion
- 5 Nov 2021 (actual)
- Study completion
- 12 Nov 2021 (actual)
- First posted
- 27 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Study subject (tooth) will be randomized in a 1:1:1 allocation ratio between the 3 gingival retraction techniques.
| Arm | Type | Receives |
|---|---|---|
| RACESTYPTINE Solution with cord | Experimental | Device: RACESTYPTINE Solution with cordThe participant will receive RACESTYPTINE Solution into the sulcus. The solution is used in combination with a non-medicated gingival retraction cord. |
| RACEGEL with cord | Experimental | Device: RACEGEL with cordThe participant will receive RACEGEL into the sulcus. The gel is used in combination with a non-medicated gingival retraction cord. |
| RACEGEL without cord | Experimental | Device: RACEGEL without cordThe participant will receive RACEGEL into the sulcus. No cord will be added. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RACESTYPTINE Solution with cordThe 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. | Device | RACESTYPTINE Solution with cord |
| RACEGEL with cordThe 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. | Device | RACEGEL with cord |
| RACEGEL without cordThe 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. | Device | RACEGEL without cord |
Primary outcome
Quantitative assessment of the lateral gingival displacement
Time frame: 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.
7 secondary outcomes
Quantitative assessment of the vertical gingival displacement
Time frame: Day 0
Oozing control assessment
Time frame: Day 0
Bleeding control assessment
Time frame: Day 0
Gingival index
Time frame: Day 0 (before and after the gingival retraction), Day 14 (end of study visit)
Papilla Bleeding index
Time frame: Day 0 (before and after the gingival retraction), Day 14 (end of study visit)
Probing depth
Time frame: Day 0 (before and after the gingival retraction), Day 14 (end of study visit)
Adverse events
Time frame: Day 0, Day 14 (end of study visit)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2021.
- Individual participant dataSharing planned: No
Related trials for Gingival Retraction Techniques
Enrolling by invitation
Efficacy of Three Gingival Displacement Methods
Tooth Defect, Teeth Restoration
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hugues Colombel, DDS principal investigator
Cabinet dentaire (Rennes)
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RACESTYPTINE Solution with cord, RACEGEL with cord and RACEGEL without cord in people with Gingival Retraction Techniques, run by Septodont at 5 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantitative assessment of the lateral gingival displacement (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2021.