Comparison Between Connective Graft and Xenogeneic Matrix, in Patients With Multiple Gingival Recessions

University of Sao Paulo

Status: Completed

Conditions: Gingival Recession, Generalized

Treatments: Procedure: Root coverage surgery

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03207984

9075852

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 37 patients

Sex: All

Ages: 15 to 60 years old

Volunteers: 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%)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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37 participants in 2 patient groups

Control SCTG

Active Comparator group

Description:

Root coverage surgery with subepithelial connective tissue graft to an extensive treat multiple gingival recessions in aesthetic areas

Treatment:

Procedure: Root coverage surgery

Test CM

Experimental group

Description:

Root coverage surgery with Mucograft® collagen matrix to treat an extensive multiple gingival recessions in aesthetic areas

Treatment:

Procedure: Root coverage surgery