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临床试验/NCT03619096
NCT03619096撤回不适用

Clinical Comparison Between Two Surgical Techniques for the Treatment of Multiple Gingival Recessions With Porcine Collagen Matrix

University of Sao Paulo2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2017年3月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
入组人数
20
试验地点
2
主要终点
Root coverage (milimeters)

研究概览

简要总结

The gold standard for gingival recession treatment is the coronal repositioning of the flap associated with the subepithelial connective tissue graft. The porcine collagen matrix (PCR) has been used as a substitute for subepithelial connective tissue graft in periodontal plastic surgery and has achieved similar results. The PCR use has the advantage of avoiding possible pre and postoperative complications , as well as overcome the limitations presented by autograft . The different surgical techniques used for root coverage seek predictability and success . For this, besides the type of incision placements flap and graft are the most important because the healing benefits and outcome .

The aim of this study is to compare two surgical techniques for root coverage and evaluate which one provides better clinical outcomes and less morbidity . 20 adults , nonsmoking patients , showing multiple bilateral gingival recessions , class I or II Miller located in canine, first and second premolars are selected. Both techniques use the PCR as a graft . However, in one Quadrant partial flap will be held together with relaxing incisions through an intrasulcular incision, PCR will be positioned 1 mm apical to the cementoenamel junction (CEJ) and the flap will be positioned 1 mm coronal CEJ. In the opposite quadrant periosteal envelope that does not use relaxing incisions, avoiding any scars, will be performed with the PCR. The clinical parameters (gingival recession height and width, keratinized tissue thickness and width) will be evaluated 2 weeks after basic periodontal therapy and after 6 and 12 months to surgical procedures..

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

盲法说明

The participants and the outcomes Assessor are masked about the surgical technique that was performed. The surgical technique ir randomized in accordance with the arch side of each patient, so the investigator will open a envelope just before starting the incisions to know which technique will be performed.

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

  • bilateral multiple gingival recession type Miller class I or II with at least one tooth with 3 mm of gingival recession height

排除标准

  • diabetics
  • pregnant women
  • chronic use of medication
  • periodontitis

研究组 & 干预措施

Test Group (tunnel technique)

Active Comparator

It Will be performed root coverage of multiple recessions using porcine collagen matrix with a tunnel Technique

干预措施: tunnel technique for Root coverage with Porcine collagen Matrix (Procedure)

Control Group (extended flap technique)

Placebo Comparator

It Will be performed root coverage of multiple recessions using porcine collagen matrix with a extended flap technique

干预措施: extended fla technique for Root coverage with Porcine collagen Matrix (Procedure)

结局指标

主要结局

Root coverage (milimeters)

时间窗: baseline, 6 and 12 motnhs

Root Coverage is measured by the difference between Gingival Recession Hight at baseline and 12 months

Change in gingival recession height (mm)

时间窗: baseline, 6, and 12 months

Gingival recession height will be measured at baseline, 6 months, and 12 months. The primary outcome will be the change in gingival recession height from baseline to 12 months.

次要结局

  • Keratinized tissue (milimeters)(baseline, 6 and 12 months)
  • Keratinized tissue width and thickness (mm)(baseline, 6, and 12 months)

研究者

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

Arthur Belem Novaes Jr

Teacher of Periodontia- Department of Buco Maxillofacial Surgery and Traumatology and Periodontics

University of Sao Paulo

研究点 (2)

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