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| Name | Class |
|---|---|
| Geistlich Pharma AG | INDUSTRY |
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Subepithelial connective tissue graft (SCTG) is considered the gold standard for root coverage treatment. However, it is associated with postoperative morbidity, limited amount of donor tissue, and longer surgical time. Thus, the search for a tissue substitute for SCTG is increasing. Currently, one of the possible autogenous soft tissue substitutes found in the market is the Mucograft® xenogeneic matrix (CM). The results with the use of MC are very promising, both for root coverage as well as for the gain of keratinized tissue. The present study consists of a parallel randomized clinical trial to compare SCTG (control group) and CM (test group) in the treatment of Miller's class I and II gingival recessions, multiple in aesthetic areas (upper central incisors, Lateral and canine).
Obtaining an aesthetic smile is one of the main reasons for the patient's demand for dental treatment, especially when it comes to gingival recession. However, there is a lack of evidence in the literature explaining the most appropriate type of treatment for multiple recessions in aesthetic areas. For unitary gingival recessions, the subepithelial connective tissue graft (SCTG) is considered the gold standard because it presents greater predictability for root coverage. However, it is associated with postoperative morbidity, limited amount of donor tissue, and longer surgical time. Thus, the search for a tissue substitute for SCTG is increasing. Currently, one of the possible autogenous soft tissue substitutes found in the market is the Mucograft® xenogeneic matrix (CM). The results with the use of CM are very promising, both for root coverage as well as for the gain of keratinized mucosa. The present study will consist of a double-blind parallel randomized clinical trial to compare SCTG (control group) and CM (test group) in the treatment of Miller's class I and II gingival recessions, multiple in aesthetic areas (central incisors, Lateral, upper canine). All measurements will be evaluated initially and in the periods of 3, 6, and 12 months after the surgical procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control SCTG | Active Comparator | Root coverage surgery with subepithelial connective tissue graft to an extensive treat multiple gingival recessions in aesthetic areas |
|
| Test CM | Experimental | Root coverage surgery with Mucograft® collagen matrix to treat an extensive multiple gingival recessions in aesthetic areas |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Root coverage surgery | Procedure | Periodontal plastic surgery aiming the treatment of multiple gingival recessions in aesthetics areas with SCTG and CM |
|
| Measure | Description | Time Frame |
|---|---|---|
| Gingival recession depth (GRD) | Distance in millimeters from ECJ to gingival margin at three points (mesial, center and distal); Distance from cemento-enamel junction to gingival margin = 0 mm | one year |
| Measure | Description | Time Frame |
|---|---|---|
| Keratinized mucosa width | Keratinized mucosa width measured with a periodontal probe in millimeters Ideal if keratinized mucosa width > 5mm | year |
| Dentin hypersensitivity | Dentin hypersensitivity measured by applying an air jet on teeth and patient fills up a visual analogue scale Ideal if scale = 0 |
| Measure | Description | Time Frame |
|---|---|---|
| Complete root coverage | Assessed in which the gingival margin was at or above the cementoenamel junction (CEJ) | year |
| Probing Depth (PD) | Distance in millimeters from the gingival margin to the bottom of the gingival sulcus at three points (mesial, center and distal) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Raphaella C Michel, PhD | University of São Paulo, Bauru School of Dentistry | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Raphaella C Michel | Bauru | São Paulo | 17012-901 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20350159 | Background | McGuire MK, Scheyer ET. Xenogeneic collagen matrix with coronally advanced flap compared to connective tissue with coronally advanced flap for the treatment of dehiscence-type recession defects. J Periodontol. 2010 Aug;81(8):1108-17. doi: 10.1902/jop.2010.090698. | |
| 21721988 | Background | Cardaropoli D, Tamagnone L, Roffredo A, Gaveglio L. Treatment of gingival recession defects using coronally advanced flap with a porcine collagen matrix compared to coronally advanced flap with connective tissue graft: a randomized controlled clinical trial. J Periodontol. 2012 Mar;83(3):321-8. doi: 10.1902/jop.2011.110215. Epub 2011 Jul 1. |
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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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| year |
| year |
| Clinical attachment level loss (CAL) | Measured in millimeters from the bottom of the periodontal pocket to the cementoenamel junction at three sites per tooth (mesial, center and distal) | year |
| Soft tissue thickness (STT) | Determined at 2mm apical the gingival margin at the central buccal site with anesthetic needle and endodontic stop and digital pachymeter | year |
| D055093 |
| Periodontal Atrophy |