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The study aims to test the non-inferiority of an Allogenic Dermal Matrix with Platelet-Rich Fibrin for treatment of gingival recessions in comparison to the Connective Tissue Graft.
Currently the Connective Tissue Graft (CTG) is referred to as the gold standard in terms of the grafting material for the treatment of gingival recession defects. This study test the non-inferiority of the Allogenic Dermal Matrix (ADM) with Platelet-Rich Fibrin (PRF) to that of the CTG, in terms of the amount of root coverage obtained after the procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Connective Tissue Graft | Active Comparator | A connective tissue graft from the patient's palate will be used |
|
| Allogenic Dermal Matrix with Platelet-Rich Fibrin | Experimental | An allogenic dermal matrix with the patient's platelet-rich fibrin will be used |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tunneled coronally advanced flap | Procedure | Describes the flap design for both treatment arms |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean root coverage (mRC) | Measured as a percentage of the total baseline recession defect that coverage was obtained at. | Assessed at 6 months |
| Complete root coverage (CRC) | Measured as a percentage of total treated sites, that obtained a full coverage of the recession defect | Assessed at 6 months |
| Keratinized tissue (KT) gain | Measured in mm | Assessed at 6 months |
| Gingival thickness (GT) gain | Measured in mm | Assessed at 6 months |
| Patient-reported outcomes (PROMs) | In terms of pain/discomfort at the palatal donor site or patient's arm. Measured using a scale from 0 (lowest) to 10 (highest). | Measured from the day of the procedure up to a maximum of 1 month |
| Duration of surgical procedure | Including the length of surgical procedure, drawing of blood, and preparation of PRF, harvesting of the autogenous CTG. Measured in minutes. | During surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Professionally evaluated esthetic score | Assessed using the Root coverage Esthetic Score (RES) system (from 0 lowest, to 10 highest) | Assessed at 6 months |
| Soft tissue volume changes over time |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hom-Lay Wang, DDS MSD PhD | University of Michigan | Principal Investigator |
| Shayan Barootchi, DMD, MS | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan - Ann Arbor | Ann Arbor | Michigan | 48109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35175005 | Background | Barootchi S, Tavelli L. Tunneled coronally advanced flap for the treatment of isolated gingival recessions with deficient papilla. Int J Esthet Dent. 2022 Feb 17;17(1):14-26. | |
| 35665500 | Background | Barootchi S, Giannobile WV, Tavelli L. PDGF-BB-enriched collagen matrix to treat multiple gingival recessions with the tunneled coronally advanced flap. Clin Adv Periodontics. 2022 Dec;12(4):224-232. doi: 10.1002/cap.10211. Epub 2022 Oct 24. |
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| ID | Term |
|---|---|
| D005889 | Gingival Recession |
| ID | Term |
|---|---|
| D005882 | Gingival Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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Assessed using 3D scanner imaging in the units of mm
| Changes of from baseline (prior to treatment) compared with 3 and 6 months |
| Soft tissue volume changes over time | Assessed using dental ultrasonography in the units of mm | Measured throughout the study to assess changes from immediate post-op (right after the completion of surgical appointment) until the final recall at 6 months |
| Soft tissue blood flow changes over time | Assessed and quantified using dental ultrasonography | Measured throughout the study to assess changes from immediate post-op (right after the completion of surgical appointment) until the final recall at 6 months |
| Patient-reported esthetics | Based on a visual analogue scale (VAS), measured as numbers from 0 (lowest) to 10 (highest). | Measured at baseline and at 6 months, and compared between these time points to provide subjective esthetic results |
| Patient-reported satisfaction | Based on a visual analogue scale (VAS), measured as numbers from 0 (lowest) to 10 (highest). | Measured at 6 months to provide the satisfaction score in VAS scale |
| Patient-reported post-operative pain as measured with a mobile application | Measured using a mobile application at the recession grafted site, the donor site on the palate, and the donor site for the venopuncture. | From the day of the procedure until 1 month after the surgical time point |
| 35353081 | Background | Tavelli L, Barootchi S. A Minimally Invasive Approach for the Treatment of Multiple Adjacent Gingival Recessions with a Volume-Stable Collagen Matrix: A Case Series. Int J Periodontics Restorative Dent. 2022 Mar-Apr;42(2):155-162. doi: 10.11607/prd.5747. |
| D055093 |
| Periodontal Atrophy |