Efficacy of Powered Versus Manual Toothbrushes on Full-Mouth Bleeding and Plaque Scores in Patients With Stage 3 or 4 Periodontitis
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Full-Mouth Bleeding Score (FMBS)
研究概览
简要总结
This study compares the effectiveness of powered and manual toothbrushes in reducing gum bleeding and dental plaque in people with stage 3 or 4 periodontitis. All participants are trained to brush for at least two minutes twice a day. The goal is to find out whether using a powered toothbrush leads to better oral hygiene results than a manual one, when brushing time is standardized. The study will measure bleeding and plaque levels at the beginning and over a 6-month period.
详细描述
This single-blind, randomized controlled trial evaluates the clinical effectiveness of powered versus manual toothbrushing in patients newly diagnosed with stage 3 or 4 periodontitis. Participants are randomly assigned to one of two groups: powered toothbrush (Oral-B iO6) or manual toothbrush (TePe Select Soft). All participants receive standardized oral hygiene instructions and are instructed to brush twice daily for a minimum of two minutes. Manual brush users are required to use a smartphone app to monitor and record brushing duration. The use of adjunctive oral hygiene aids, such as mouthwash or interdental cleaners, is restricted throughout the study period. The primary clinical outcomes are full-mouth bleeding score (FMBS) and full-mouth plaque score (FMPS), measured at baseline and at follow-ups of 7 days, 1 month, 3 months, and 6 months.
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
The clinical investigator who interacts with participants and the outcomes assessor responsible for evaluating clinical indices (FMBS and FMPS) are both blinded to group allocation. Participants are instructed not to disclose the type of toothbrush they are using. The masking helps ensure unbiased data collection and outcome assessment throughout the study.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged 18 to 75 years
- •Diagnosis of stage 3 or 4 periodontitis based on clinical and radiographic examination
- •Retaining at least 16 natural teeth
- •Ability to follow oral hygiene instructions and compliance with the study protocol
- •Willingness to refrain from using additional oral hygiene products (e.g., mouthwash, interdental cleaners) during the study
- •Ability to provide informed consent
排除标准
- •Presence of systemic conditions that may affect oral health (e.g., uncontrolled diabetes, immunocompromised states)
- •Pregnancy or breastfeeding
- •Ongoing use of antibiotics or other medications that could interfere with gum health
- •Severe dental conditions (e.g., tooth mobility > 2, advanced root resorption)
- •Prior use of a powered toothbrush within the last 6 months
- •Participation in another clinical trial that could interfere with study outcomes
- •Inability or unwillingness to comply with study requirements or provide informed consent
结局指标
主要结局
Full-Mouth Bleeding Score (FMBS)
时间窗: FMBS will be assessed at baseline and at 7 days, 1 month, 3 months, and 6 months following the intervention.
The Full-Mouth Bleeding Score (FMBS) will be used to assess the level of gingival bleeding upon gentle probing across all teeth in the mouth. This measure will evaluate the overall gum health of participants and will help compare the effectiveness of the powered versus manual toothbrushes in reducing gingival inflammation. FMBS will be recorded at baseline, 7 days, 1 month, 3 months, and 6 months to monitor changes in bleeding over time.
次要结局
- Systolic and Diastolic Blood Pressure (SBP and DBP)(SBP and DBP will be measured at baseline, 1 month, 3 months, and 6 months.)
研究者
Davide Pietropaoli
PI Davide Pietropaoli, Professor
University of L'Aquila