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临床试验/NCT02632968
NCT02632968Unknown4 期

Pinhole Surgical Technique With And Without Use Of Button Application For Treatment Of Multiple Gingival Recessions: A Comparative Controlled Randomized Clinical Trial

Krishnadevaraya College of Dental Sciences & Hospital2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2013年11月1日最近更新:
适应症

试验速览

阶段
4 期
发起方
入组人数
80
试验地点
2
主要终点
Percentage of Mean Root Coverage

研究概览

简要总结

Pinhole surgical technique is a novel minimally invasive, predictable, efficient, time and cost-effective technique for treatment of multiple gingival recession. This procedure involves no releasing incision, suturing or sharp dissections. It has been shown that the greater post-operative displacement of gingival margin may cause greater root coverage. Based on this hypothesis, a split mouth randomized controlled clinical trial was planned to compare the clinical outcome of pinhole surgical technique with and without the use of orthodontic buttons and sutures in the treatment of multiple gingival recessions.

详细描述

To achieve multiple adjacent recession coverage and an optimal integration of the associated tissues is even more challenging and a complex endeavour in comparison to isolated gingival recessions. Treatment protocol and outcome with different surgical procedures depends on a variety of factors like recession, defect size, presence or absence of keratinized tissue adjacent to the defect, width and height of inter-dental soft tissue, depth of vestibule, presence of frenum, post-operative stabilization and final position of advanced gingival margin. The final position of the GM plays a critical role in achieving CRC. Based on this hypothesis, a split mouth clinical trial was planned to compare the clinical outcome of pinhole surgical technique with and without the use of orthodontic buttons and sutures in the treatment of multiple gingival recessions.

METHOD The aim of this split-mouth randomized controlled clinical trial was to clinically compare and evaluate the effectiveness and predictability of Pinhole surgical technique alone and its modification with orthodontic buttons and sutures in 80 sites for the treatment of multiple gingival recessions and to assess the influence of these surgical procedures on the gingival and periodontal health, in the maxillary arch for six months post surgically. Gingival recession depth (GRD), Gingival margin location post-surgery, Gingival recession width (GRW), Root coverage esthetic score (RES), Complete root coverage (CRC), Probing depth (PD), Clinical attachment level (CAL), Keratinized tissue width (KTW), Plaque index (PI), Gingival index (GI), Gingival bleeding index (GBI) will be measured at baseline, 6 weeks, 3 months and 6 months after treatment.

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 (Investigator)

入排标准

年龄范围
25 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Multiple (atleast two or three) Millers class I and II or combined class I and II recession defects18 affecting adjacent teeth of the maxillary arch.
  • Patients with thick gingival biotypes >0.8mm.
  • Presence of adequate keratinized tissue apical to recession > 1mm.
  • Age group 25-55 years.
  • Patients with history of compliance to oral hygiene instructions and a full mouth plaque score of <10%.
  • Patients willing to participate in the study.
  • American Society of Anaesthesiologists Physical Status I or II.
  • No contra-indications for periodontal surgery.
  • Non-Smokers.
  • Patients with esthetic concerns.

排除标准

  • Recession defects associated with caries/demineralization, restorations, and deep abrasions (step >2mm).
  • No occlusal interferences.
  • Teeth with evidence of pulpal pathology.
  • Patients who have undergone any previous periodontal surgical procedures at the involved sites.
  • Pregnant and lactating women.
  • Patients on medications known to interfere with periodontal tissue health or healing.

结局指标

主要结局

Percentage of Mean Root Coverage

时间窗: 6 months

Complete Root Coverage

时间窗: 6 months

Root Coverage Esthetic Score

时间窗: 6 months

Recession Depth Reduction

时间窗: 6 months

次要结局

  • Gingival Recession Width Reduction(6 months)
  • Probing Depth (PD)(6 months)
  • Clinical Attachment Level (CAL)(6 months)
  • Keratinized Tissue Width (KTW)(6 months)
  • Bleeding Index (BI)(6 months)
  • Gingival Index (GI)(6 month)
  • Plaque Index(6 months)

研究者

发起方
Krishnadevaraya College of Dental Sciences & Hospital
申办方类型
Other
责任方
Sponsor

研究点 (2)

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