The Effects of Ozone Therapy on Wound Healing After Gingivectomy Operations: a Controlled Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- wound healing change
研究概览
简要总结
the aim of present study was to evaluate effects of ozone therapy on wound healing after gingivectomy and gingivoplasty operations as a model of secondary wound healing.. Twenty three systemically healthy individuals participated in this study. Ozone was applied immediately after surgery, at 1st day and 3rd day after gingivectomy surgery. In the photographs of the wounds, the difference in color were evaluated and measurements were performed at the baseline, 3rd, 7th, 14th days after surgery.
详细描述
Although ozone therapy has often been tried in medical science and has become more popular due to its antimicrobial, biocompatibility and healing properties, the effects of ozone therapy on surgeries that heals with secondary intention were not studied. In the lights of these informations, the aim of present study was to evaluate effects of ozone therapy on wound healing after gingivectomy and gingivoplasty operations as a model of secondary wound healing. Twenty three systemically healthy individuals participated in this study. All periodontal examinations were performed by one experienced examiner and non-surgical periodontal treatment of the patients were performed within two weeks after initial examination by the same clinician.Gingivectomy and gingivoplasty operations were performed by another examiner who was unaware of the study protocol.After gingivectomy and gingivoplasty, right quadrants of the surgical areas were assigned to receive ozone therapy in all patients. Ozone therapy was also performed by an experienced periodontist. As placebo application, left quadrants received regular air from the ozone generator.Postoperative pain was assessed at 3rd, 7th, 14th days after surgery with a visual analog scale At baseline and 3rd, 7th, 14th days after surgery, surgical area was disclosed by a plaque disclosing solution to visualize the epithelization degree of the surgical areas. Solution provided a clear vision to distinguish normal gingiva from the areas in which the gingival epithelium is absent, abraded or lacking sufficient keratinization. In order to evaluate epithelization degree of the wounds, standardized photographs were taken from each patient.In the photographs of the wounds, the difference in color were evaluated and darkly stained areas were considered as lack of enough epithelization. These measurements were performed at the baseline, 3rd, 7th, 14th days after surgery. The determinations were done by a calibrated examiner who was blind to test and control sites
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
placebo applications were performed to mask participant
investigator who applied ozone, did not evaluate the healing
Investigator who evaluate the healing, did not know the control and test sides.
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 to 35 years of age
- •systemically healthy
- •non-smokers
- •no medications taken for 6 months
- •no pregnancy and lactation
- •no contraindications for periodontal surgery
- •no gingivectomy or mucogingival surgical history in the lower incisor region.
排除标准
- •<18 and > 35 years of age
- •systemical disease
- •smoking and alcohol consumption
- •medications taken for 6 months
- •pregnancy and lactation
- •contraindications for periodontal surgery
- •gingivectomy or mucogingival surgical history in the lower incisor region.
研究组 & 干预措施
ozone group
After gingivectomy and gingivoplasty, right quadrants of the surgical areas were assigned to receive ozone therapy in all patients
干预措施: ozone device ( Ozonytron XL ) (Device)
non-ozone group
placebo application, left quadrants received regular air from the ozone generator.
结局指标
主要结局
wound healing change
时间窗: At baseline and 3rd, 7th, 14th days after surgery, wound healing evaluation were performed.
surgical area was disclosed by a plaque disclosing solution to visualize the epithelization degree of the surgical areas. Solution provided a clear vision to distinguish normal gingiva from the areas in which the gingival epithelium is absent, abraded or lacking sufficient keratinization. In order to evaluate epithelization degree of the wounds, standardized photographs were taken from each patient
次要结局
- Pain change(Postoperative pain was assessed at 3rd, 7th, 14th days after surgery)
研究者
Zekeriya Tasdemir
Principal investigator
TC Erciyes University