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临床试验/NCT06646432
NCT06646432招募中不适用

Treatment of Gingival Recession by Tunnel Technique Using Connective Tissue Graft With or Without Injectable Platelet Rich Fibrin: A Randomized Controlled Clinical Trial

Suez Canal University2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
30
试验地点
2
主要终点
Recession depth

研究概览

简要总结

Gingival recession is a common periodontal problem. Consequences include teeth sensitivity, poor esthetics and impaired oral hygiene access. Mild cases are managed by optimizing oral hygiene measures, correction of any causative factor such as faulty tooth brushing, improper dental restoration or denture clasp. Prescription of desensitization products such as specific tooth gels or mouth washes can manage the sensitivity problem. Deeper recession defects need to be addressed by surgical procedures. Coronally advanced flap with connective tissue graft is the gold standard procedure. However, it has some drawbacks due to the need for papillary incisions and vertical incisions in some cases. Within the era of minimally invasive periodontology, tunnel technique with connective tissue graft showed results comparable to coronally advanced flap with connective tissue graft but with some limitations. Addition of another agent may enhance the results of tunnel technique. Injectable platelet rich fibrin is known for its content of growth factors and effects on soft tissue healing. Aim: The study aim is to compare the surgical management of gingival recession with tunnel technique using connective tissue graft and injectable platelet rich fibrin to tunnel with connective graft without injectable platelet rich fibrin.

Methodology: 30 patients with miller class I or II gingival recession will be enrolled. 15 in the test group (Tunnel+ CTG+ i-PRF) and 15 in control group (Tunnel+ CTG). Clinical evaluation at 6 months

详细描述

30 patients with miller class I/II gingival recession will be enrolled in this study.

15 patients will be treated using tunnel technique and palatal connective tissue graft inserted and sutured under the prepared tunnel after being soaked in injectable platelet rich fibrin for 15 minutes. The tunnel with the underlying graft will be advanced coronally. (Test Group) The other 15 patients will be treated the same way as in the first group but without soaking the graft in injectable platelet rich fibrin. (Control Group) Clinical parameters will be evaluated at baseline and 6 months follow-up except post-operative pain which will be assessed after 10 days. Histologic examination of small piece of the graft will be done to assess if there is true saturation of growth factors inside the graft.

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 (Outcomes Assessor)

入排标准

年龄范围
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • More than 21 years old
  • Systemically healthy
  • Presence of Miller class I/II gingival recession
  • Presence of identifiable CEJ

排除标准

  • Systemic disease that contraindicates surgical procedures.
  • Poor compliance with oral hygiene measures
  • Necrotizing gingival conditions
  • Ongoing active periodontitis

结局指标

主要结局

Recession depth

时间窗: 6 months after the surgery

it will be recorded as the distance between the CEJ and gingival margin-measurements were performed at the mid-buccal aspect of the teeth, by manual probe and were rounded up to the nearest millimeter.

Keratinized tissue height

时间窗: 6 months

It will be measured from the mucogingival junction to the gingival margin-measurements were performed at the mid-buccal aspect of the teeth, by manual probe and were rounded up to the nearest millimeter.

Gingival thickness

时间窗: 6 months

It will be measured at a mid-buccal location 1 mm apical to the probing depth level with an spreader. It will be pierced, perpendicularly to the mucosal surface, through the soft tissue with light pressure until a hard surface is felt. The silicone disk stop will then be placed in tight contact with the soft tissue surface. Penetration depth will be measured.

次要结局

  • Post operative pain(10 days)
  • Recession width(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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