The Effects of Ozone Therapy as an Adjunct to Periodontal Treatment: A Randomized Split-Mouth Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 主要终点
- Periodontal disease parameters change
研究概览
简要总结
This randomized, placebo controlled, split-mouth clinical study trial evaluates the effects of Ozone therapy on clinical and biochemical parameters. Total of 20 participants completed the study . Periodontal parameters were evaluated at baseline and 3 months following periodontal therapy. All participants were treated non-surgically. Topical gaseous ozone was applied into periodontal pockets. Gingival crevicular fluid pentraxin-3 (PTX-3), interleukin-1β (IL-1β) and high sensitivity C-reactive protein (Hs-CRP) were evaluated.
详细描述
Ozone therapy (OT) is very popular in medicine. Especially it use for wound healing and antibacterial properties. This randomized, placebo controlled, randomized split-mouth clinical study evaluates the effects of ozone therapy on clinical and biochemical parameters. Total of 20 participants completed the study (10 males, 10 females). Periodontal parameters, including plaque index (PI), gingival index (GI), probing depth (PD), percentage of bleeding on probing, percentage of pockets deeper than 5 mm and clinical attachment level (CAL), and percentage of ≥3 mm clinical attachment level. Periodontal parameters were evaluated at baseline and 3 months following periodontal therapy. All participants were treated non-surgically. Topical gaseous ozone was applied into periodontal pockets twice a week for 2 weeks during active periodontal therapy. Gingival crevicular fluid pentraxin-3 (PTX-3), interleukin-1β (IL-1β) and high sensitivity C-reactive protein (Hs-CRP) were evaluated.
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, Investigator)
盲法说明
Investigators who evaluate the clinical and biochemical parameters did no know the groups.
And participants did not know ozone device work or not when holding the probe.
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 to 64 years of age
- •Generalized chronic periodontitis(Armitage, 1999)
- •Systemically healthy
- •More than 20 teeth (excluding third molars)
排除标准
- •Periodontal treatment within 6 months
- •Antibiotic use within the previous 3 months
- •Pregnancy and lactation
- •Past or current smoking and alcohol consumption
- •Contraindications for OT
- •Patients with class II and III furcation defects(Staffileno, 1969)
研究组 & 干预措施
ozone group
topical gaseous ozone was applied into periodontal pockets during active periodontal therapy
干预措施: Ozone application with the Ozonytron XL device (Device)
non-ozone group
Only active periodontal therapy was performed
结局指标
主要结局
Periodontal disease parameters change
时间窗: Examinations were performed at baseline and 3 months after periodontal therapy. Changes is determined with baseline values - 3 months after periodontal treatment.
Probing depth (mm) were evaluated by periodontal probe.
次要结局
- Gingival crevicular inflammatory parameter change(inflammatory biochemical parameters were analyzed at baseline and 3 months after periodontal therapy and changes is determined with baseline values - 3 months after periodontal therapy.)
研究者
Zekeriya Tasdemir
Principal investigator
TC Erciyes University