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临床试验/NCT03207984
NCT03207984已完成不适用

Xenogeneic Collagen Matrix and Connective Tissue Graft Comparison for Multiple Gingival Recessions in Esthetic Areas: A Non-inferiority Clinical Trial

University of Sao Paulo2 个研究点 分布在 1 个国家目标入组 37 人开始时间: 2017年3月8日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
37
试验地点
2
主要终点
Gingival recession depth (GRD)

研究概览

简要总结

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).

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
15 Years 至 60 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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%)

结局指标

主要结局

Gingival recession depth (GRD)

时间窗: 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

次要结局

  • Keratinized mucosa width(year)
  • Dentin hypersensitivity(year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Raphaella Coelho Michel

Principal investigator

University of Sao Paulo

研究点 (2)

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