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The primary aim of this study is to evaluate whether the use of a xenogenic collagen matrix (XCM) for the treatment of multiple adjacent gingival recessions (MAGRs) with a multiple coronally advanced flap technique (mCAF) achieves better results than the use of an autologous connective tissue graft (CTG) in terms of recession reduction (primary outcome) and other secondary root coverage outcomes (e.g. complete root coverage, mean root coverage). Moreover, this study aims to compare secondary clinical variables (e.g. keratinized tissue width (KTW) changes, probing pocket depth (PPD) changes, volumetric gain (VG), etc.), also with a digital approach, the patient-reported outcome measures (PROMs e.g. pain, swelling, bleeding). The hypothesis of this study is that at 6 months and 1 year follow-up the mCAF with XCM is not inferior to CTG in terms of recessions reduction and secondary clinical variables, and superior regarding to PROMs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Xenogenic collagen matrix (XCM) | Experimental | Multiple coronally advanced flap technique (mCAF) with the use of a XCM |
|
| Connective tissue graft (CTG) | Active Comparator | Multiple coronally advanced flap technique (mCAF) with the use of a CTG |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Use of XCM for the treatment of MAGRs with mCAF technique | Device | After local anaesthesia, mCAF technique will be performed. XCM will be adapted on the root surfaces and positioned at the level of the cemento-enamel junction. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Recession Reduction (RecRed) | Mean changes in mm in recession depth between baseline and 1-year | 6 months; 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Complete Root Coverage (CRC) | Percentage of sites with complete root coverage after 1-year | 6 months; 1 year |
| Mean Root Coverage (MRC) | Percentage of mean root coverage after 1-year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mario Aimetti, MD | Contact | 0116331546 | mario.aimetti@unito.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CIR Dental School | Recruiting | Turin | 10126 | Italy |
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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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| Treatment of MAGRs with CTG | Procedure | After local anaesthesia, mCAF technique will be performed. CTG will be adapted on the root surfaces and positioned at the level of the cemento-enamel junction. |
|
| 6 months; 1 year |
| Keratinised tissue height (KTH) changes | Linear changes in mm from the gingival margin to the mucogingival junction between baseline and 1-year | 6 months; 1 year |
| Post-operative morbidity (pain, swelling, discomfort) | Assessment of patient's pain, swelling and discomfort at 14 days after the procedure using visual analogue scale (VAS) ranging from 0 (no pain, swelling or discomfort) to 10 (maximum pain, swelling or discomfort) with a questionnaire | 14 days |
| D055093 |
| Periodontal Atrophy |