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临床试验/CTRI/2025/09/095292
CTRI/2025/09/095292尚未招募不适用

Evaluating Papilla Access Tunnel Technique with Platelet-Rich Fibrin and Amnion-Chorion Membrane for Management of Anterior Gingival Recessions: A Randomized Controlled Trial

Dr Shruti Singh1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2025年10月6日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
12
试验地点
1
主要终点
Probing Pocket Depth

研究概览

简要总结

Gingival recession, also known as soft tissue recession, is defined as the displacement of

the gingival margin apical to the cemento-enamel junction (CEJ) of a tooth or the platform

of a dental implant.This condition is associated with issues like dentine

hypersensitivity, non-carious cervical lesions (NCCLs), and compromised aesthetics.

Dealing with recession defects in the anterior region presents challenges due to various

anatomical factors, including the depth of the vestibule, position of the tooth, pull of

muscles and frenulum, and thickness of hard and soft tissues.

Several surgical techniques have been proposed over the years for treating mucogingival

defects in the aesthetic zone of the dentition. The Coronally Advanced Flap (CAF) along

with Subepithelial connective tissue graft (SCTG) is considered the gold standard for the

treatment of gingival recessions . Its advantages include a perfect color/contour match

with surrounding tissue and simplicity of execution.

The tunnel technique, introduced by Allen in 1994 , has evolved and the Papilla Access

tunnel technique, introduced by Edward P. Allen in 2019, is now suggested as a more

realistic option for gingival recession treatment in the anterior region. This technique

preserves papillary integrity and provides incision-free design, allowing improved surgical

access for site preparation and graft placement with reduced risk of perforation or injury to

thinner tissues

Intrasulcular approach for preparation of the tunnel site in Papilla Access tunnel technique

is accomplished easily when treating multiple tooth sites where a few of the teeth may

present with significant amount of recession by using the access provided by an elongated

sulcus associated with the recession defect.

Regarding the use of membranes. Choukroun’s platelet-rich fibrin (PRF), a secondgeneration

platelet concentrate developed in 2001 (Choukroun et al,2001), is an autologous

leukocyte and platelet-rich fibrin biomaterial. PRF offers advantages such as simplified

and efficient preparation in a single-step centrifugation process, without the need for

anticoagulants or other gelling agents.

Recently, placental-derived tissues, known for their immune privileged composition,

antibacterial properties, and facilitation of cell migration, have gained popularity in

dentistry for guided tissue regeneration . Amnion membrane, an allogenic substitute

for subepithelial connective tissue graft, is particularly used for cost-effective root coverage

.The amnion contains stem cell reserves, growth factors, and proteins that accelerate

healing and regeneration, while the chorion is rich in collagen proteins. Based on these

biological properties, amnion and chorion membranes are theorized to be effective in

managing gingival recession and are being employed in root coverage procedures.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Investigator Blinded

入排标准

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

入选标准

  • Patients presenting with Recession Type 1 RT1 Cairos classification of gingival recession involving maxilla and mandibular anterior teeth.
  • Patients who have not undergone any previous root coverage procedures Width of attached gingiva more than or equal to 2mm Patients with normal hemogram report.

排除标准

  • Patients with compromised systemic diseases Pregnancy Patients on antibiotic therapy for the past 6 months Smokers Patients with coagulation disorders Patients with malaligned anteriors.

结局指标

主要结局

Probing Pocket Depth

时间窗: At baseline | 3 months | 6 months

Clinical attachment level

时间窗: At baseline | 3 months | 6 months

Complete root coverage

时间窗: At baseline | 3 months | 6 months

Mean root coverage

时间窗: At baseline | 3 months | 6 months

Recession depth

时间窗: At baseline | 3 months | 6 months

Width of keratinized tissue

时间窗: At baseline | 3 months | 6 months

次要结局

  • Root Coverage Aesthetic Score(Patient Reported Outcome Measures)

研究者

发起方
Dr Shruti Singh
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr. Shruti Singh

Manipal College of Dental Sciences, Mangalore

研究点 (1)

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