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临床试验/NCT02534415
NCT02534415已完成4 期

Effect of Topically-Applied Hyaluronic-Acid on Palatal Epithelial Wound Closure

Marmara University0 个研究点目标入组 36 人开始时间: 2013年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
36
主要终点
Pain

研究概览

简要总结

Aim of the study is to assess the therapeutic effects of topical hyaluronic-acid use on secondary wound healing of the free gingival graft donor site. The hypothesis of this study is that topical hyaluronic-acid gel has positive effects on secondary wound healing of free gingival graft donor site by reducing pain, burning sensation, and accelerating the healing.

详细描述

The objective of the randomized, single blind, controlled and parallel clinical trial was to assess therapeutic effects of topical hyaluronic-acid on secondary wound healing of free gingival graft donor site.

Primary outcome variables that pain and burning sensation changes were assessed at 3, 7, 14, 21 days after surgery by the examiner. Pain and burning sensation were assessed by patients using the VAS, score 0 indicate no pain or burning sensation, score 10 indicate severe pain or burning sensation. Secondary outcome variables included color match, consistency and epithelization of the wound area. These parameters were assessed by the same examiner at 3, 7, 14, 21 and 42 days after surgery. Color of the palatal mucosa was assessed by comparing it to that of the adjacent and opposite site using the VAS. Score 0 indicate no color match and score 10 indicate very good color match. Consistency of the palatal mucosa was assessed with a blunt instrumentation and scored as soft or firm. Epithelialization was scored clinically as none, partial or complete.

Sample size has been estimated in 12 subjects per treatment groups. Random allocation of the treatment sites to test and control groups will be performed using a computerized selection of random numbers for allocation of the study groups.

Clinical images obtained at baseline, 3, 7, 14, 21 and 42 days after surgery from each treatment site.

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 (Participant)

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

  • Good general health
  • No periodontal surgical treatment in the previous 6 months on the involved sites

排除标准

  • Patients with a pregnancy or lactation period
  • Self-reported history of antibiotic medication within three months
  • Absence of tooth in the area of donor site

研究组 & 干预措施

Periodontal dressing material

Active Comparator

Palatal wound area was covered with periodontal dressing material at baseline and 3rd day

干预措施: Periodontal dressing material (Drug)

0.2% Hyaluronic acid gel

Experimental

0.2% topical hyaluronic-acid gel was applied to palatal wound area and covered with periodontal dressing material (Peripac®) at baseline and 3rd day

干预措施: 0.2% Hyaluronic acid gel (Drug)

0.8% Hyaluronic acid gel

Experimental

0.8% topical hyaluronic-acid gel was applied palatal wound area and covered with periodontal dressing material (Peripac®) at baseline and 3rd day

干预措施: 0.8% Hyaluronic acid gel (Drug)

结局指标

主要结局

Pain

时间窗: 21 days

Using a visual analog scale (0: No pain, 10: Severe pain)

次要结局

  • Color match(42 days)
  • Consistency(42 days)
  • Epithelialisation(42 days)
  • Burning Sensation(21 days)

研究者

申办方类型
Other
责任方
Sponsor

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