Effect of Ozone Oil After Non-surgical Periodontal Treatment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Probing Depth
研究概览
简要总结
The goal of this clinical trial is to evaluate the use of ozone oil as an adjunctive of non-surgical periodontal treatment (NSPT) on diabetics type 2 patients (DM2) compared to control group with chronic periodontal disease.
The principal question is to evaluate if the ozone oil could improve periodontal clinical parameters.
Thirty-two sites of 16 diabetics type 2 patients (DM2) with moderate to advanced periodontal disease containing two sites with periodontal pocket depth (PPD) of > 5 mm were selected.
The treatment was distributed in 2 groups in the split mouth design: Control- scaling and root planing + saline solution (control) and Test - scaling and root planning + ozone oil
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, Care Provider)
盲法说明
Participants - The randomization performed will use the coin heads or tails method, Investigators -Two treatments at randomly chosen sites separate in two groups: Ozone oil use as an adjunctive of scaling and root planing and saline solution 0.09%, as a control, associate as an adjunctive of scaling and root planing. Ultrasonic scaler and Gracey curets use to remove all calculus and biofilms during scaling and root planing. The oils are numbere syringes labeled 1 and 2 for blinded applications, and 1 ml of each oil were administrated in a previous selected site. After removing baseline samples of biofilm, the scaling and root planing were performed using ultrasonic devices and manual Gracey curettes.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Periodontitis
- •Systemic type 2 diabetes
排除标准
- •Hypersensitivity to ozone oil
- •Osteoporosis types I and II
- •Alcoholism
- •Immunosuppressio
- •Pregnant and lactating
- •Physical/emotional stress drugs
- •Use of antibiotics, anti-inflammatories and hormone
- •Oral candidiasis
- •Received periodontal treatment in the last six months prior to the procedure
研究组 & 干预措施
Control
Scaling and root planing + saline solution gel (control) will be adminster at probing depth > 5mm.
干预措施: Control (Drug)
Test
Scaling and root planing + Ozone Oil will be adminster at probing depth > 5mm.
干预措施: test (Drug)
结局指标
主要结局
Probing Depth
时间窗: baseline
mm
clinical attachment level
时间窗: baseline
mm
Plaque Index
时间窗: baseline
Percentage
Gingival Index
时间窗: baseline
Percentage
次要结局
- Gingival Index(3 months)
- Probing Depth(3 months)
- clinical attachment levels(3 months)
- Plaque Index(3 months)
研究者
Gabriela Alessandra da Cruz Galhardo Camargo
Clinical Professor
Universidade Federal Fluminense