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Gingival recession (GR) is frequently associated with deterioration in dental esthetics and dental hypersensitivity. Outcomes from recent systematic reviews have demonstrated that when the root is covered and the gain in the width of keratinized tissue (KT) is expected, the use of subepithelial connective tissue grafts (SCTGs) associated with coronally advanced flaps (CAF) appears to be more predictable, and may be considered the gold standard procedure. However, the SCTGs may increase patients' morbidity (e.g., pain). This occurs because of the need for a donor surgical area, which may increase the risk of surgical complications like bleeding, as well as increases post-operative discomfort and the period of the surgical procedure. Another biomaterial, a new collagen matrix (CM) has been used as a substitute for the SCTG. The use of CM was associated with a significant reduction in post-operative morbidity, less post-operative pain and discomfort in the patient, and more esthetic satisfaction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Collagen Matrix plus coronally advanced flap (CAF) | Experimental | A new collagen matrix (Mucograft) associated to coronally advanced flap |
|
| Subepithelial connective tissue graft plus CAF | Active Comparator | Subepithelial connective tissue graft associated to coronally advanced flap |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coronally advanced flap (CAF) | Procedure | The test group will be treated by means of the association of Collagen Matrix + Coronally Advanced Flap. As treatment, the control group will receive the association of a subepithelial Conjunctive Tissue Graft + Coronally Advanced Flap. The aim of both procedures will be to obtain root coverage. All these procedures will be performed in a standardized manner. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of root coverage (RC) | The primary clinical outcome will be percentage of root coverage (RC) at 12 months | 12-months |
| Measure | Description | Time Frame |
|---|---|---|
| Reductions in recession depth (RRD) | Measured from the cementum-enamel junction (CEJ) up to the highest point of the gingival margin | At the baseline, 3-month, 6-month and 12-months |
| Complete root coverage of the gingival recessions (CRC) |
| Measure | Description | Time Frame |
|---|---|---|
| Subject esthetic satisfaction by participants | The participants will be invited to reply to a questionnaire on subject esthetic satisfaction with the surgical results (from dissatisfied to very satisfied) on a scale of 1-5, as well as after 1, 3, 6 months and after 12 months. | 1, 3, 6 months and after 12 months |
| Subjective symptoms of pain and discomfort by participants |
Inclusion Criteria:
The patients will be included in the study if they fulfill the following inclusion criteria:
Exclusion Criteria: -
The exclusion criteria used will be as follows:
The exclusion criteria for teeth will be:
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| Name | Affiliation | Role |
|---|---|---|
| Giuseppe Romito, PhD | University of Sao Paulo | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of São Paulo | São Paulo | 05508-000 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23050490 | Result | Jepsen K, Jepsen S, Zucchelli G, Stefanini M, de Sanctis M, Baldini N, Greven B, Heinz B, Wennstrom J, Cassel B, Vignoletti F, Sanz M. Treatment of gingival recession defects with a coronally advanced flap and a xenogeneic collagen matrix: a multicenter randomized clinical trial. J Clin Periodontol. 2013 Jan;40(1):82-9. doi: 10.1111/jcpe.12019. Epub 2012 Oct 10. | |
| 20350159 |
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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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| ID | Term |
|---|---|
| C000623317 | Mucograft |
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|
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| Collagen Matrix | Drug | A new collagen membrane |
|
|
| Subepithelial connective tissue graft | Procedure | Connective tissue graft |
|
|
| At the baseline, 3-month, 6-month and 12-months |
| Recession width (RW) at the cemento-enamel junction | At the baseline, 3-month, 6-month and 12-months |
| Relative clinical attachment level (RCAL) | Measured from a fixed point (stent) prepared on the acrylic guide up to the base of the gingival sulcus. | At the baseline, 3-month, 6-month and 12-months |
| Probing depth (PD) | Calculated as RCAL- PD; | At the baseline, 3-month, 6-month and 12-months |
| keratinized tissue width (KT) | From the free gingival margin to the mucogingival junction. | At the baseline, 3-month, 6-month and 12-months |
| Gain in thickness of gingival tissue (GT) | With an injection needle and a silicon marker, 2mm below the gingival margin. | At the baseline, 3-month, 6-month and 12-months |
Subjective symptoms of pain and discomfort (without pain and with a great deal of pain) will be evaluated with 10 cm (0-10) visual analog scales (VAS) at 1, 2, 3-week, 1 month, 3-month, 6-month and12-months. |
| At 1, 2, 3-week, 1 month, 3-month, 6-month and12-months. |
| Esthetic questionnaire by experienced periodontist | One experienced periodontist will be invited to observe the initial photographs and those of the clinical results obtained during the entire healing process and asked to respond to an esthetic questionnaire (from dissatisfied to very satisfied) on a scale of 1 to 5 points after 1, 2, 3-week, 1-month, 3-month, 6-month and 12-months.12 All this examinations also will be performed in the clinic. | 1, 2, 3-week, 1-month, 3-month, 6-month and 12-months after surgery |
| 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. |
| 19678861 | Result | Sanz M, Lorenzo R, Aranda JJ, Martin C, Orsini M. Clinical evaluation of a new collagen matrix (Mucograft prototype) to enhance the width of keratinized tissue in patients with fixed prosthetic restorations: a randomized prospective clinical trial. J Clin Periodontol. 2009 Oct;36(10):868-76. doi: 10.1111/j.1600-051X.2009.01460.x. Epub 2009 Aug 12. |
| D055093 |
| Periodontal Atrophy |