Xenogeneic Collagen Matrix and Connective Tissue Graft Comparison for Multiple Gingival Recessions in Esthetic Areas: A Non-inferiority Clinical Trial
| Registry | NCT03207984 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: single, treatment |
| Enrollment | 37 (Actual) |
| Sponsor | University of Sao Paulo (Other); collaborators: Geistlich Pharma AG |
| Conditions | Gingival Recession, Generalized |
| Interventions | Root coverage surgery (Procedure) |
| Dates | start 2017-03-08, primary completion 2020-09-20, completion 2021-12-01, first posted 2017-07-05, last updated 2023-03-02 |
| Locations | 1 site in Brazil |
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All trials for Gingival Recession, Generalized All trials of Root coverage surgery
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Control SCTG | Active comparator | Procedure: Root coverage surgery | Root coverage surgery with subepithelial connective tissue graft to an extensive treat multiple gingival recessions in aesthetic areas |
| Test CM | Experimental | Procedure: Root coverage surgery | Root coverage surgery with Mucograft® collagen matrix to treat an extensive multiple gingival recessions in aesthetic areas |
Sex: All, ages: 15 Years to 60 Years, accepts healthy volunteers
Inclusion Criteria: * Clinical diagnosis of multiple gingival recessions ≥ 2 mm, only in aesthetic areas (upper central and lateral incisive, and canine); * Miller class I and II gingival recession areas * Non-abrasive, erosive, or carious root surfaces * Unrotated, non-extruded, and non-movable teeth * Systemically healthy patients without contraindication to periodontal surgical procedures Exclusion Criteria: * Smokers * Pregnant women and infants * Patients with a history of periodontal disease or recurrent abscess formation * Patients previously submitted to surgical procedures for root coverage * Patients taking anti-convulsant drugs * Antihypertensives, contraceptives or immunosuppressors * Patients with low oral hygiene (plaque and bleeding index over 20%)
| Facility | City | Country | Status |
|---|---|---|---|
| Raphaella C Michel | Bauru, São Paulo | Brazil |