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临床试验/NCT07655349
NCT07655349招募中不适用

Clinical Evaluation of Titanium Tacks Used for the Stabilization of Free Gingival Graft in Gingival Augmentation Around Natural Teeth: A Randomized Controlled Clinical Trial

Karim Abdelrahim Mohamed Abdelsamad1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2025年3月17日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
24
试验地点
1

研究概览

简要总结

The goal of this clinical trial is to learn whether titanium tacks can be used as an alternative to sutures for stabilization of free gingival grafts (FGG) around natural teeth. It will also evaluate the effect of each stabilization technique on patient comfort and clinical outcomes.

The main questions it aims to answer are:

  • Does stabilization of free gingival grafts using titanium tacks reduce post-operative pain compared with conventional suturing?
  • Does stabilization of free gingival grafts using titanium tacks affect clinical outcomes such as keratinized tissue width, gingival thickness, graft dimensions, procedure time, plaque accumulation, and interference with daily activities?

Researchers will compare free gingival graft stabilization using titanium tacks with the conventional suturing technique to determine whether titanium tacks provide comparable or improved outcomes.

Participants will:

  • Receive a free gingival graft around natural teeth requiring augmentation of keratinized gingival tissue.
  • Be assigned to have the graft stabilized either with titanium tacks or with conventional resorbable sutures.
  • Attend scheduled follow-up visits for clinical examinations and measurements.
  • Report their post-operative pain levels using a Visual Analogue Scale (VAS).
  • Complete assessments related to daily life interference during the healing period.
  • Undergo evaluation of keratinized tissue width, gingival thickness, graft dimensions, plaque index, and procedure time.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients age 18 years or older.
  • Patients with healthy systemic condition.
  • Indication for FGG treatment (i.e., difficulty or discomfort during oral hygiene; gingival margin mobility; high muscle attachment and/or frenum pull; shallow vestibule and gingival recession) around natural teeth.
  • Keratinized tissue width (KTW) < 2 mm.
  • Good oral hygiene.
  • Cooperative patients.

排除标准

  • Pregnant females.
  • Smokers: a contraindication for any plastic periodontal surgery.
  • Unmotivated and uncooperative patients with poor oral hygiene.
  • Patients with habits that may compromise the longevity and affect the result of the study as parafunctional habits.
  • Patients who have undergone periodontal surgery in the same area within 6 months.

研究者

发起方
Karim Abdelrahim Mohamed Abdelsamad
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Karim Abdelrahim Mohamed Abdelsamad

Bachelor's degree holder and Master's degree student

Cairo University

研究点 (1)

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