The Effect of Ozone Therapy on Pain Perception After Free Gingival Graft Surgery in Patients With Mucogingival Defects A Randomized Controlled Clinical Trail
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Evaluation of postoperative pain using visual analog scale.
研究概览
简要总结
Gaseous ozone (O3-triatomic oxygen) is the third-strongest oxidizing agent worldwide. It influences the cellular and the humoral immune system, by stimulating the proliferation of immunocompetent cells and the synthesis of immunoglobulin. Additionally; biologically active substances, such as interleukins, leukotrienes and prostaglandins which are beneficial in reducing inflammation and wound healing are orchestrated following ozone application. Given that after harvesting of a free gingival graft from the palatal donor site, healing occurs by secondary intention process; for patients with mucogingival conditions. The investigators will compare the natural process of healing at the donor site versus the healing process consecutive to ozone application; with the primary outcome is to evaluate the postoperative pain perception using visual analogue scale and to estimate the consumption of analgesics tablets after surgery.
详细描述
The procedures will be explained to all participants and they will be asked to sign an informed consent.
All patients will receive oral hygiene instructions and will receive phase I therapy comprising supragingival scaling and subgingival debridement.
After completion of phase I therapy the patients will be re-examined to ensure meeting all inclusion criteria. Then the participants will be allocated to 2 groups.
Group I will receive ozone therapy after harvesting free gingival graft. Group II following the harvesting of the free gingival graft, will be protected by a periodontal pack.
Surgical intervention:
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
- Double (Participant, Outcomes Assessor)
盲法说明
Double- blinded
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with mucogingival defects to be treated with free gingival grafts.
- •Age older than 18 years old.
- •No history of periodontal surgery in the area to be treated.
- •Full mouth plaque score (FMPS) and full mouth bleeding score (FMBS) less than 20%.
排除标准
- •Pregnancy and lactation.
- •History of systematic diseases or medications that interferes with periodontal wound healing.
结局指标
主要结局
Evaluation of postoperative pain using visual analog scale.
时间窗: 7 days
Postoperative pain will be evaluated by visual analog scale (VAS) (Crichton, 2001). In this method, the patients will be asked to rate their pain at examination in form of a score between 0 (no pain) and 10 (the most pain which patient has ever experienced). This assessment will be made every day for the first 7 days following the FGG operation.
Evaluation of postoperative pain
时间窗: 7 days
The participants will report the number of analgesic tablets ingested to relieve the pain.
次要结局
- Evaluation of complete epithelialization of the palatal wound.(28 days)
研究者
Omaima Mossad Mahmoud AL-Sherbini
Principle investigator
Cairo University