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临床试验/NCT03435068
NCT03435068已完成不适用

The Evaluation of Soft Tissue Wound Healing Following Different Gingivectomy Applications: A Prospective Randomized Clinical Trial

T.C. Dumlupınar Üniversitesi0 个研究点目标入组 45 人开始时间: 2016年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
45
主要终点
Postoperative wound healing change

研究概览

简要总结

The aim of this study was to evaluate the degree of clinical discomfort and the issues experienced by patients and to use a software image program to compare wound healing during the 2-week period following gingivectomy performed with different techniques.

详细描述

Horizontal and vertical gingival overgrowth indexes were evaluated before and after surgery during each follow-up controls. The vertical distance of gingival tissue was measured from the gingival margin to the cement-enamel junction (gingival overgrowth [GO] index). Horizontal gingival values were also recorded between the tooth surfaces and the papillary tissue surface at the interdental contact point as buccolingual aspect (mesiobuccal [MB] index).

Postoperative Evaluations

The postoperative parameters, including pain, burning, edema, vascularization, erythema, epithelization, bleeding and carbonization, were recorded at 1, 3, 5, 7, and 14 days postoperatively.

Postoperative pain, burning, erythema, vascularization, and edema were assessed via the visual analogue scale (VAS). The VAS is a 100-mm horizontal-line scale that is used to quantify subjective symptoms such as pain, burning, erythema, vascularization, and edema. In the present study, researchers used a standard VAS on which patients drew a vertical sign along a 10-cm scale from 0 (no pain) to 10 (highest degree of pain). Bleeding and carbonization during the postoperative period were assessed as either present or absent. Patients evaluated their postoperative pain, burning, and bleeding values. The same researcher evaluated erythema, vascularization, edema, and epithelization values.

Evaluation of Surgical Wound Area After gingivectomy operation, the surgical site was evaluated with hydrogen peroxide to detect the presence of epithelization. A blinded researcher who used a standard digital camera to take standard magnification photographs assessed the operation area, consisting of the epithelium. The researcher examined all photographs with the assistance of an image-analyzing software program. The mesio-distal width of the maxillary right central tooth was recorded for each patient, and photographs were calibrated via the reference values. In the areas subjected to hydrogen peroxide application and experiencing tissue reaction, there was a lack of an epithelial layer in the wound area. The wound surface areas of foamy fields on the all of the groups' photographs were recorded on days 1, 3, 5, 7, and 14 following the gingivectomies.

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
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • The criteria for inclusion in the study were as follows:
  • systemically healthy individuals
  • nonsmokers
  • horizontal and vertical gingival overgrowth indexes with a "score 1" or "score 2"
  • mean bleeding on probing and mean plaque index value < 20% (indicating good oral hygiene)
  • no clinical attachment loss and
  • a minimum of four teeth at each surgical site.

排除标准

  • The exclusion criteria were as follows:
  • systemic disease that could influence the outcome of the treatment, -pregnancy and/or lactation,
  • conditions requiring antibiotic prophylaxis and anti-inflammatory medications, -acute or untreated periodontitis
  • the use of an analgesic before the surgical procedure.

结局指标

主要结局

Postoperative wound healing change

时间窗: The wound surface areas of foamy fields on the all of the groups' photographs were recorded change between 1st day and 14th day following the gingivectomies.

After gingivectomy operation, the surgical site was evaluated with hydrogen peroxide to detect the presence of epithelization

次要结局

  • Postoperative pain(Visual analogue Scale, minimum score is 0 and maximum score is 10.Change of VAS values were recorded on days between 1st and 14th days following the gingivectomies)
  • Postoperative burning(Visual analogue Scale, minimum score is 0 and maximum score is 10.Change of VAS values were recorded on days between 1st and 14th days following the gingivectomies)
  • Postoperative erythema(Visual analogue Scale, minimum score is 0 and maximum score is 10.Change of VAS values were recorded on days between 1st and 14th days following the gingivectomies)

研究者

发起方
T.C. Dumlupınar Üniversitesi
申办方类型
Other
责任方
Principal Investigator
主要研究者

Berceste Guler

Assist .Prof

T.C. Dumlupınar Üniversitesi

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