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临床试验/NCT05684913
NCT05684913已完成不适用

Cukurova University Faculty of Dentistry

Cukurova University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年3月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
2
主要终点
Post-operative pain

研究概览

简要总结

There is no study in the literature showing the effects of Zn on wound healing after free gingival graft (FGG) operation. The aim of this randomized clinical study was to compare the early healing results of the palatal wound after FGG harvesting by sterile hemostatic agent suturing or the use of surgical stent from thermoplastic Zn-containing granules which was prepared chairside.

详细描述

There are many studies reporting paresthesia, herpetic lesion, mucocele, excessive bleeding and severe postoperative pain after procedure.The highest pain level perceived in the palatal region after the FGG operation is experienced on the first day after the operation and decreases to the preoperative levels approximately 2 weeks after the operation. Although hemostatics, bioactive substances, antibacterial and antiseptic agents, herbal effective products, platelet concentrations, low-dose laser applications, palatal stents are used in the palatal region to accelerate the healing stages and prevent such complications, an ideal support has not been found.

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)

盲法说明

The investigator assessing the clinical outcomes is blinded to the study groups

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Periodontal and systemically healthy
  • ≥19 years old
  • Amount of attached gingival width in the maxillary or mandibular anterior region <2 mm
  • Full mouth plaque index score, bleeding index score on full-mouth probing <15%
  • Exclusion criteria;
  • Previously undergone surgery for a graft harvested from the palate
  • Presence of systemic disease
  • Taking medication known to interfere with periodontal health

排除标准

  • 未提供

结局指标

主要结局

Post-operative pain

时间窗: post operative 8 weeks

Pain was scored from 0 to 10 experienced by the patients as a result of palatal wound (0: no pain, 1: minimal pain, 10: severe pain).

次要结局

  • Bleeding(post operative 7 days)
  • Burning sensation(post operative 8 weeks)
  • Change in dietary habits(post operative 8 weeks)
  • Patient discomfort(post-operative 8 weeks)
  • Complete epithelization(post-operative 8 weeks)

研究者

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

Mustafa Ozcan

Associate Professor

Cukurova University

研究点 (2)

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