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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-A00179-32 | Other Identifier | identifier from the French National Agency of Health (ANSM) |
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| Name | Class |
|---|---|
| Slb Pharma | OTHER |
| Rennes University Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| RACEGEL without cord | Experimental | The participant will receive RACEGEL into the sulcus. No cord will be added. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RACESTYPTINE Solution with cord | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 0 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 0 |
| Oozing control assessment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hugues Colombel, DDS | Cabinet dentaire (Rennes) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cabinet dentaire | Cesson-Sévigné | 35510 | France | |||
| Cabinet dentaire Dr Rubin |
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Study subject (tooth) will be randomized in a 1:1:1 allocation ratio between the 3 gingival retraction techniques.
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Blinding will be done to the assessors who analyzed dental impression to reduce bias to gingival tissue displacement assessment
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| RACEGEL with cord | Device | 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. |
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| RACEGEL without cord | Device | 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. |
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The dentist visually assesses the presence or absence of crevicular fluid in the sulcus immediately after removing the retraction material. |
| 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. | 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. | 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. | 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. | 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. | Day 0, Day 14 (end of study visit) |
| Rennes |
| 35000 |
| France |
| Cabinet dentaire Magister | Rennes | 35000 | France |
| Cabinet dentaire | Rennes | 35000 | France |
| Cabinet dentaire - Médipole 35 | Tinténiac | 35190 | France |