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临床试验/NCT03615092
NCT03615092已完成不适用

Acellular Dermal Matrix Graft In Root Coverage of Gingival Recessions With Previously Restored Cervical Lesions. A Controlled Clinical Trial

University of Sao Paulo1 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2011年1月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
17
试验地点
1
主要终点
Root coverage

研究概览

简要总结

Patients with high standards of oral hygiene frequently search for buccal gingival recession (GR) treatment due to cervical wear, root sensitivity and compromising aesthetics. The cervical lesion (NCCL) is commonly produced by improper toothbrushing techniques, sharing the same etiology of GR. Many different surgical approaches have been described. The association of a graft to the coronally advanced flap had demonstrated the best long-term outcome for root coverage. But, substitutes for the autogenous graft must be studied. Therefore, the aim of this clinical trial was to investigate the effectiveness of the acellular dermal matrix graft (ADMG) in root coverage associated with a previous restored cervical lesion or not.

Material and methods: Seventeen individuals with bilateral GR were included in the study. At one side, the GR must present a previously restored cervical lesion, as the test group (TG). The contralateral arch, must present GR with an intact root surface (CG). All patients were treated with the extended flap technique associated with the ADMG. All clinical parameters were assessed at baseline and 6-months postoperative.

研究设计

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

盲法说明

The clinical parameters were screened by one single examiner that was not aware of the procedures

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • CEJ without significant damage;
  • localized bilateral RT112 gingival recession ≥3 mm in the same arch, in which one had a non-carious cervical lesion (NCCL) restored with composite and the opposite one was intact

排除标准

  • previous periodontal surgical treatment on the involved sites;
  • pregnants or lactating
  • compromised systemic health and contraindications for periodontal surgery

研究组 & 干预措施

Test Group

Active Comparator

Active Comparator: gingival recession with a previous restored cervical lesion

the aim of this study is to compare if the acellular dermal matrix graft is as efficient as a substitute for the connective graft used in root coverage of gingival recessions with non carious cervical lesions.

干预措施: Root coverage with extended flap technique and acelular dermal matrix (Procedure)

Control Group

Placebo Comparator

the aim of this study is to compare if the acellular dermal matrix graft is as efficient as a substitute for the connective graft used in root coverage of gingival recessions with non carious cervical lesions. The control group had no cervical lesion, and was treated with the same technique as the acelular dermal matrix graft

干预措施: Root coverage with extended flap technique and acelular dermal matrix (Procedure)

结局指标

主要结局

Root coverage

时间窗: 6 months

Root coverage is measured by the difference between the gingival recession height at 6 months and baseline

次要结局

  • Keratinized tissue(6months)

研究者

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

Arthur Belem Novaes Jr

Phd, Ms, DDs. Chairman of Periodontolgy

University of Sao Paulo

研究点 (1)

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