跳至主要内容
临床试验/NCT06603467
NCT06603467进行中(未招募)不适用

Guided Versus Non-Guided Harvesting Technique of Soft Tissue Graft in Cairo Recession Type I Sites: a Randomized Clinical Trial

Tanta University2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年4月15日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
20
试验地点
2
主要终点
Early Wound Healing Score (EHS) EHS

研究概览

简要总结

The goal of this clinical trial is to compare the healing pattern in the palate following harvesting of deepithelialized free gingival graft by two different harvesting techniques and to compare the recession coverage at the recipient sites.

. The main questions it aims to answer are:

• Does the harvesting technique will affect the healing pattern &the recipient site coverage in the treatment of gingival recession?

Participants will:

  • Receive in the recession sites, in group 1 deepithelialized free gingival graft harvested without guide & group 2: will be covered with graft harvested with guide
  • Visit the clinic twenty-four hours after surgery and weekly visits for 1 month, early wound healing at the sites of harvesting will be assessed
  • The recession coverage will be assessed at 3& 6 months after surgery

详细描述

Background: Over the last few years, deepithelialized free gingival graft has become a gold standard treatment modality for increasing the width of keratinized gingiva, root coverage, alveolar ridge deficiencies management of peri-implant tissue abnormalities, and papillary loss. The procedure of harvesting the graft from the palate is often associated with the noteworthy challenge of procurement of the largest volume of tissue possible while minimizing associated trauma to anatomical structure, also special designs of the graft may be required. To meet these requirements and overcome the challenges, an innovative digitally designed guide for harvesting the graft is designed to allow ideally designed graft with minimal trauma to the tissue.

Aim: To compare the healing pattern in palate following harvesting of deepithelialized free gingival graft by two different harvesting techniques and to compare the recession coverage at the recipient sites.

Methodology: Twenty recession sites with RT1 Cairo classification will be recruited for this study. Sites were randomly divided into 2 treatment groups as follows: group 1 :10 sites will be covered with deepithelialized free gingival graft harvested without guide & group 2 :10 sites will be covered with CTG harvested with guide. Sites in both groups will be covered with laterally or coronally positioned flap. Twenty-four hours after surgery and weekly visits for 1 month, early wound healing at the sites of harvesting will be assessed using the Early Wound Healing Score (EHS) EHS. This score assessed clinical signs of re-epithelialization (CSR), clinical signs of hemostasis (CSH), and clinical signs of inflammation (CSI). Since complete wound epithelialization was the main outcome, the CSR score was weighted to be 60% of the total final score. Accordingly, a score of 0, 3, or 6 points was possible for the assessment of CSR, whereas scores of 0, 1, or 2 points were possible for CSH and CSI. Higher values indicated better healing. Accordingly, the score for ideal early wound healing was 10. Regarding soft tissue coverage, Gingival recession depth (GRD) & Gingival recession width (GRW) will be measured at baseline, 3 and 6 months after surgery. Also, each group will be subjected to intraoral scanning at baseline, 3 and 6 months after surgery to measure gingival thickness and level by superimposition of scanning files of different intervals to monitor the changes by software.

Statistical analysis will be done using IBM SPSS Statistics for Windows, version 23 (IBM Corp., Armonk, NY, USA). Intergroup analysis was done using Mann-Whitney test and intra-group analysis will be done using Kruskal-Wallis test for all the study parameters. Statistical significance will set at a p-value of less than 0.05.

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
None

入排标准

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

入选标准

  • Gingival recession sited classifies as Cairo type I
  • must have a general health showing no contraindications for oral surgery,
  • must be at least 20 years old.
  • patients also had to have good oral hygiene before the treatment

排除标准

  • signs or symptoms of bruxism or clenching i
  • patients suffering from uncontrolled systemic conditions
  • pregnant or lactating

结局指标

主要结局

Early Wound Healing Score (EHS) EHS

时间窗: 6 month

Early Wound Healing Score (EHS) EHS. This score assessed clinical signs of re-epithelialization (CSR), clinical signs of hemostasis (CSH), and clinical signs of inflammation (CSI). Since complete wound epithelialization was the main outcome, the CSR score was weighted to be 60% of the total final score. Accordingly, a score of 0, 3, or 6 points was possible for the assessment of CSR, whereas scores of 0, 1, or 2 points were possible for CSH and CSI. Higher values indicated better healing. Accordingly, the score for ideal early wound healing was 10

次要结局

  • Recession depth(6 months)
  • gingival thickness(6 months)
  • recession width(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

safinaz saleh mohamed saeed

lecturer in periodontology

Tanta University

研究点 (2)

Loading locations...

相似试验