Interdental Plaque Reduction After Use of Different Devices in Patients With Periodontitis: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- FMPS Full-mouth plaque score (FMPS)
研究概览
简要总结
To determine the efficacy of four different oral hygiene protocols involving adjunctive interdental cleaning devices in periodontal patients in terms of plaque and gingival inflammatory scores.
详细描述
Patients included in the study will undergo a thorough clinical examination aiming at collecting all the data desired: periodontal parameters of Probing Pocket Depth (PPD), presence of recession of the gingival margin (Rec) and full mouth plaque score (FMPS) will be recorded on six sites/tooth by a single calibrated examiner using a University of North Carolina (UNC) 15-mm periodontal probe by a calibrated examiner blind to group allocation.
Gingival index (GI) and angulated bleeding score (AngBS) will be recorded at four sites/tooth.
For GI the following scale will be used:
0 normal appearance of gingiva, no bleeding, no inflammation;
- slight change and moderate edema with slight change in texture, no bleeding, mild inflammation;
- redness hypertrophy, or edema and glazing, bleeding on probing, moderate inflammation;
- marked redness, hypertrophy, or edema, ulceration, spontaneous bleeding, severe inflammation.
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
Center will enroll probands, assigning a unique study subject number and allocating an opaque randomization envelope.
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
- •males or females of age range between 18 and 70 years,
- •good health status,
- •presence of at least 20 natural teeth
- •residual periodontal pockets with PPD≥4mm, in need of specific oral hygiene regimen.
排除标准
- •pregnancy or breast-feeding,
- •indication to antibiotic therapy prior to treatment,
- •chronic infections,
- •systemic diseases (including cardiovascular, pulmonary, cerebral, and metabolic diseases),
- •not willing to give a consent
结局指标
主要结局
FMPS Full-mouth plaque score (FMPS)
时间窗: Measured at: Baseline, at 1 week, at 3 weeks, and at 5 weeks
Changes in FMPS, measured orally through clinical examination. Unit of measure: N
次要结局
- Clinical attachment level (CAL)(Measured at Baseline and at 5 weeks)
- Gingival Index (GI)(Measured at: Baseline, at 1 week, at 3 weeks, and at 5 weeks)
- Pocket probing depth (PPD)(Measured at Baseline and at 5 weeks)
- Recession of the gingival margin (REC)(Measured at Baseline and at 5 weeks)
- Angulated bleeding score (AngBS)(Measured at: Baseline, at 1 week, at 3 weeks, and at 5 weeks)
研究者
Filippo Graziani, DDS MClinDent PhD
Full Professor
University of Pisa