跳至主要内容
临床试验/CTRI/2025/04/084878
CTRI/2025/04/084878尚未招募2 期

Comparative evaluation of de-epithelialized gingival unit graft (d-GUG) using modified bridge flap technique and de-epithelialized gingival unit graft (d-GUG) alone in management of gingival recession - A randomized controlled clinical study

SELF1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年7月30日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
SELF
入组人数
30
试验地点
1
主要终点
To evaluate the root coverage by using de-epithelialized gingival unit graft with modified bridge flap technique

研究概览

简要总结

Gingival recession is a condition where the denudation of root surfaces occurs due to the relocation of the gingival margin apical to the cement-enamel junction (CEJ), leading to root hypersensitivity and aesthetic problems.

AIM OF THE STUDY The aim of present study is to evaluate and compare soft tissue parameters and root coverage using de epithelized gingival unit graft (d-GUG) along with modified bridge flap technique and de epithelized gingival unit graft (d-GUG) alone in Gingival Recession.

OBJECTIVES OF THE STUDY: To evaluate the root coverage by using de-epithelialized gingival unit graft with modified bridge flap technique. To evaluate the root coverage by using de-epithelialized gingival unit graft alone.

GROUP I (TEST): 15 sites will be treated by de epithelized gingival unit graft (d-GUG) along with modified bridge flap technique.

GROUP II (CONTROL): 15 sites will be treated by de epithelized gingival unit graft (d-GUG) alone.

Following clinical parameters will be measured using University of North Carolina (UNC) – 15 and assessed at baseline, 1 month and 3 months. Customized acrylic stents for each patient, with grooves corresponding to mid buccal surface of defects will be made to ensure accurate readings. Recession depth (RD) – the distance between cementoenamel junction (CEJ) and most apical portion of the gingival   margin. Recession width (RW) – width of recession defect at the level of CEJ. Probing depth (PD) – distance from the gingival margin to bottom of the gingival sulcus. Thickness of keratinized tissue (KTT) – determined at a distance of 1.5 mm apical to gingival margin using short anesthesia needle and rubber disc stopper.

研究设计

研究类型
Interventional
分配方式
Random Number Table
盲法
Participant, Investigator and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • Individuals from 18 to 50 years Single/two adjacent teeth with miller’s class I or class II gingival recession defects Teeth with identifiable Cemento Enamel Junction (CEJ) Nonsmoker.

排除标准

  • Prominent root surface Presence of anatomic factors such as shallow vestibule/inadequate keratinized gingiva or aberrant frenum which might impair passive coronal positioning of the flap Presence of non-carious cervical lesions or root caries Pregnant patients Patients with systemic conditions.

结局指标

主要结局

To evaluate the root coverage by using de-epithelialized gingival unit graft with modified bridge flap technique

时间窗: To evaluate the root coverage by using de-epithelialized gingival unit graft with modified bridge flap technique | To evaluate the root coverage by using de-epithelialized gingival unit graft alone | To compare the outcome of both the techniques at baseline 4 weeks and 12 weeks

To evaluate the root coverage by using de-epithelialized gingival unit graft alone

时间窗: To evaluate the root coverage by using de-epithelialized gingival unit graft with modified bridge flap technique | To evaluate the root coverage by using de-epithelialized gingival unit graft alone | To compare the outcome of both the techniques at baseline 4 weeks and 12 weeks

To compare the outcome of both the techniques

时间窗: To evaluate the root coverage by using de-epithelialized gingival unit graft with modified bridge flap technique | To evaluate the root coverage by using de-epithelialized gingival unit graft alone | To compare the outcome of both the techniques at baseline 4 weeks and 12 weeks

次要结局

未报告次要终点

研究者

发起方
SELF
申办方类型
Other [nil]

研究点 (1)

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