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

Not Applicable
Completed
Conditions
Gingival Recession, Generalized
Interventions
Procedure: Root coverage surgery
Registration Number
NCT03207984
Lead Sponsor
University of Sao Paulo
Brief Summary

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).

Detailed 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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
37
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
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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%)
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Control SCTGRoot coverage surgeryRoot coverage surgery with subepithelial connective tissue graft to an extensive treat multiple gingival recessions in aesthetic areas
Test CMRoot coverage surgeryRoot coverage surgery with Mucograft® collagen matrix to treat an extensive multiple gingival recessions in aesthetic areas
Primary Outcome Measures
NameTimeMethod
Gingival recession depth (GRD)one year

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

Secondary Outcome Measures
NameTimeMethod
Keratinized mucosa widthyear

Keratinized mucosa width measured with a periodontal probe in millimeters Ideal if keratinized mucosa width \> 5mm

Dentin hypersensitivityyear

Dentin hypersensitivity measured by applying an air jet on teeth and patient fills up a visual analogue scale Ideal if scale = 0

Trial Locations

Locations (1)

Raphaella C Michel

🇧🇷

Bauru, SP, Brazil

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