Comparison Between Interdental Brush and Water Floss on Plaque Accumulation and Gingival Inflammation in Patients Undergoing Fixed Orthodontic Treatment: A Single Blinded Split-Mouth Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Plaque Index
研究概览
简要总结
The goal of this clinical trial is to test the ability of water flosser to remove plaque and reduce gingival inflammation in patients undergoing fixed orthodontic treatment.
The main questions it aims to answer are:
Does water flosser remove plaque effectively in orthodontic patients? Does water flosser reduce gum inflammation in orthodontic patients?
Researchers compared water flosser to interdental brush to see if there is a difference in plaque and inflammation reduction.
Participants used interdental brush to clean between their teeth and around brackets in one side of their mouth, and they used water flosser to clean between the teeth and around brackets in the other side. The study lasted for 3 months.
详细描述
- Study design This is a randomized controlled single blinded clinical trial, with split mouth design.
- Sample size Forty seven subjects with fixed orthodontic appliance were recruited from patients attending dental teaching clinics at Jordan University of Science and Technology. The age range was between 18 and 35 years. They were randomly assigned to use interdental brush on one side of the mouth, and water floss on the other side in a split mouth design.
The study lasted for 3 months.
- Inclusion criteria:
1. Patients with fixed orthodontic appliance in the upper and lower arches. 2. Patients with healthy gingiva with no periodontal disease. 3. Patient's orthodontic plan doesn't require extraction of any teeth during the study period. .
4. Patients should have at least 26 teeth. 5. Patients are motivated and able to clean their teeth. 6. Patients should not have caries, overhang restorations, crowns, bridges or implants 7. Adults 18-35 years old. 2. Exclusion criteria:
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)
盲法说明
patients know what they're using, but examiner measuring plaque/gingival index is blinded
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
- •Patients with fixed orthodontic appliance upper and lower arches.
- •Patients with healthy gingiva with no periodontal disease.
- •Patient's orthodontic plan doesn't require extraction of any teeth during the study period.
- •Patients should have at least 26 teeth.
- •Patients are motivated and able to clean their teeth.
- •Patients should not have caries, overhang restorations, crowns, bridges or implants.
- •Adults 18-35 years old.
排除标准
- •Medically compromised patients.
- •Pregnant woman.
- •Using mouth wash or antibiotic in last 3 months.
研究组 & 干预措施
Interdental brush
Participants used an interdental brush twice daily for interdental cleaning on the assigned side
干预措施: Interdental brush (Device)
Water Flosser
Participants used a water flosser twice daily for interdental cleaning on the other assigned side
干预措施: Water floss (Device)
结局指标
主要结局
Plaque Index
时间窗: Baseline, 2 weeks, 4 weeks, 2 month and 3 months
Plaque accumulation assessed using the Rustogi Modified Navy Plaque Index (RMNPI) on designated tooth surfaces in the sides assigned to interdental brush and water flosser. The tooth was divided into multiple zones as the following : Whole mouth: areas A,B,C,D,E,F,G and H. Marginal (gum line): areas A,B and C. Interproximal: areas D and F 0 score was given the area where there is no plaque. 1 score was given in the area where there is plaque The minimum plaque score per surface (buccal or lingual) is zero, and the maximum plaque score per surface is 8 Intraoral photos using professional camera were taken for all teeth and all surfaces to record the plaque score.
Plaque Index
时间窗: Baseline, 2 weeks, 4 weeks, 2 month and 3 months
Plaque accumulation assessed using the Rustogi Modified Navy Plaque Index (RMNPI) on designated tooth surfaces in the sides assigned to interdental brush and water flosser. The tooth was divided into multiple zones as the following : Whole mouth: areas A,B,C,D,E,F,G and H. Marginal (gum line): areas A,B and C. Interproximal: areas D and F 0 score was given the area where there is no plaque. 1 score was given in the area where there is plaque The minimum plaque score per surface (buccal or lingual) is zero, and the maximum plaque score per surface is 8 Intraoral photos using professional camera were taken for all teeth and all surfaces to record the plaque score.
次要结局
- Visual Analog Scale (VAS)(2 Weeks, 4 weeks, 2months, and 3months)
- Visual Analog Scale (VAS)(2 Weeks, 4 weeks, 2months, and 3months)
- Gingival Index(Baseline, 2 weeks, 4 weeks, 2 months ,and 3 months)
研究者
Lana Bader
Dr, Assistant Professor
Jordan University of Science and Technology