The Efficacy of Different Methods of Teeth Cleaning on the Levels of Volatile Sulfur Compounds in Patients With Orthodontic Fixed Appliances
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change in volatile sulphur compounds causing halitosis at four weeks.
研究概览
简要总结
To determine the effect of different cleaning methods and devices in reducing halitosis during active orthodontic treatment.
详细描述
. Observer - blind clinical trial, randomly divided into four groups, A, B, C and D. each group will undergo clinical evaluation and oral malodor assessment and they will be assigned electric or manual toothbrushes with super floss or water floss respectively.clinical evaluation will include plaque index (PI), gingival bleeding index (GBI), bracket index.and halitosis will be measured by halimeter .
Measurements and time frame: Initial measurements (T0), after two weeks (T1), and after four weeks (T2) ( according to previous studies that uses the same period of time for measurements),17, 18 plaque index (PI), gingival bleeding index (GBI), bracket index and halimeter reading .
During the first week after the start of the study (T0)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 14 Years 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •participants with fixed orthodontic appliance.
- •participants age 14 years and above and didn't have mental of physical disabilities.
- •participants willing to comply with given oral hygiene instructions.
排除标准
- •patients with mental retardation.
- •patients with systematic diseases.
研究组 & 干预措施
ManualTB+Floss
Cleaning teeth with a manual toothbrush and a dental floss three times a day.
干预措施: Manual Toothbrush (Device)
ManualTB+Floss
Cleaning teeth with a manual toothbrush and a dental floss three times a day.
干预措施: Dental floss (Device)
ManualTB+Waterjet
Cleaning teeth with a manual toothbrush and a waterjet three times a day.
干预措施: Manual Toothbrush (Device)
ManualTB+Waterjet
Cleaning teeth with a manual toothbrush and a waterjet three times a day.
干预措施: Waterjet (Device)
Electric TB+Floss
Cleaning teeth with an electric toothbrush and dental floss three times a day .
干预措施: Dental floss (Device)
Electric TB+Floss
Cleaning teeth with an electric toothbrush and dental floss three times a day .
干预措施: Electric Toothbrush (Device)
Electric TB +Waterjet
Cleaning teeth with an electric toothbrush and a waterjet three times a day .
干预措施: Waterjet (Device)
Electric TB +Waterjet
Cleaning teeth with an electric toothbrush and a waterjet three times a day .
干预措施: Electric Toothbrush (Device)
结局指标
主要结局
Change in volatile sulphur compounds causing halitosis at four weeks.
时间窗: At baseline then and after four weeks then
Tanita Breath Checker HC-312SF Fitscan to measures volatile sulphur compounds with six levels of odor.
Change in volatile sulphur compounds causing halitosis at eight weeks.
时间窗: At four weeks from baseline and after eight weeks then
Tanita Breath Checker HC-312SF Fitscan to measures volatile sulphur compounds with six levels of odor.
次要结局
未报告次要终点
研究者
Omar Alkadhi
Assistant professor
Riyadh Colleges of Dentistry and Pharmacy