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临床试验/NCT06723314
NCT06723314已完成不适用

Evaluation of Patient Morbidity and Root Coverage Outcomes of Vestibular Incision Sub Periosteal Tunnel Access Versus Coronally Advanced Flap in Treating Gingival Recession in Esthetic Zone, Randomized Clinical Trial

Misr International University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2018年1月15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
30
试验地点
1
主要终点
Pain Score

研究概览

简要总结

To evaluate and compare Vestibular Incision Subperiosteal Tunnel Access (VISTA) technique,with connective tissue graft; versus Coronally Advanced Flap (CAF) technique;with connective tissue graft, in treating gingival recession in esthetic zone. Patients and Methods: Thirty patients, with Miller class I or class II gingival recession, were included in the current study, with age range from 18 to 55 years. Defects were treated using either VISTA combined with connective tissue graft technique, or CAF combined with connective tissue technique. Post-operative discomfort was evaluated using the Visual Analog Scale (VAS) to assess patient morbidity. At baseline, 3, 6 and 9 months, clinical parameters were assessed; Probing Depth (PD), Clinical Attachment Level (CAL), Gingival recession Height (GH), Keratinized Tissue Height (KTH), while Complete and Mean Root Coverage (CRC, MRC) were recorded after nine months. Results: The present study revealed that VISTA showed higher significant difference in pain.VISTA also showed a more reduction in PD, CAL, GH as well as KTH than that of CAF with no significant difference between either of the groups.

详细描述

To evaluate and compare Vestibular Incision Subperiosteal Tunnel Access (VISTA) technique,with connective tissue graft; versus Coronally Advanced Flap (CAF) technique;with connective tissue graft, in treating gingival recession in esthetic zone. Patients and Methods: Thirty patients, with Miller class I or class II gingival recession, were included in the current study, with age range from 18 to 55 years. Defects were treated using either VISTA combined with connective tissue graft technique, or CAF combined with connective tissue technique. Post-operative discomfort was evaluated using the Visual Analog Scale (VAS) to assess patient morbidity. At baseline, 3, 6 and 9 months, clinical parameters were assessed; Probing Depth (PD), Clinical Attachment Level (CAL), Gingival recession Height (GH), Keratinized Tissue Height (KTH), while Complete and Mean Root Coverage (CRC, MRC) were recorded after nine months. Results: The present study revealed that VISTA showed higher significant difference in pain.VISTA also showed a more reduction in PD, CAL, GH as well as KTH than that of CAF with no significant difference between either of the groups. Conclusions: Based on the results of the current study, it can be concluded that both techniques allow improvement in root coverage with no significant differences between them, while VISTA technique showed more pain scores by the VAS than that of CAF technique.

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
Double (Investigator, Outcomes Assessor)

盲法说明

The surgeon performing the surgical technique as well as the patient cannot be blinded because the two surgical procedures are different and recognizable by both the surgeon and the patient after being well informed

入排标准

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

入选标准

  • •Age between 18- 55 years
  • •No sexual discrepancy
  • •Medically free
  • •Good oral hygeine
  • •Sound teeth with single (measuring ≥ 2 mm) or Multiple (measuring ≥ 1 mm)
  • •Class I or II gingival recession defects and adequate amount of keratinized tissue (3mm width).

排除标准

  • •Patients on anticoagulants, antiplatelets, or glucocorticoids.
  • •Pregnant females or lactating female patients
  • •Smoking patients.
  • •Patients with parafunctional habits.
  • •Tooth extraction in the surgical sites, active periodontal disease or history of previous surgery in the same area.

研究组 & 干预措施

Vestibular Subperiosteal Tunnel Access

Experimental

Vestibular Subperiosteal Tunnel Access

干预措施: Vestibular Subperiosteal Tunnel Access vista (Procedure)

Coronally Advanced Flap

Active Comparator

Coronally Advanced Flap

干预措施: Vestibular Subperiosteal Tunnel Access vista (Procedure)

结局指标

主要结局

Pain Score

时间窗: 1-10 days

Visual Analogue Scale to measure pain from (0-10) with 0 (no pain) and 10 (worst pain)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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