Sonic Toothbrush Versus an Oscillating-rotating Toothbrush on Plaque Control and Gingival Health (SONICOR)
A Randomized Crossover Clinical Trial Comparing a Sonic Toothbrush Versus an Oscillating-rotating Toothbrush on Plaque Control and Gingival Health
研究概览
详细说明
This study is a single-center, randomized, evaluator-blinded, 2×2 crossover clinical trial designed to compare the effectiveness of a sonic toothbrush and an oscillating-rotating powered toothbrush in improving oral hygiene and gingival health in adult participants.
Participants will be randomly assigned to one of two intervention sequences. Each intervention period will last three weeks and will be separated by a three-week washout period during which standardized oral hygiene measures will be used to minimize potential carryover effects. The total study duration for each participant will be nine weeks.
At baseline and follow-up visits, participants will undergo oral examinations and standardized assessments performed by a trained examiner blinded to the assigned toothbrush. Clinical and salivary measurements will be collected throughout the study according to the protocol schedule. Participants will receive standardized oral hygiene instructions and will be provided with the same fluoridated toothpaste for the entire study period. The use of additional antiseptic oral products or intensive oral hygiene devices will not be permitted during the intervention periods unless clinically indicated.
The study aims to generate updated clinical evidence regarding the comparative performance of two widely used powered-toothbrush technologies under controlled conditions. The crossover design allows each participant to serve as his or her own control, reducing inter-individual variability and increasing the precision of treatment comparisons.
The study will be conducted at the Hospital Odontològic Universitat de Barcelona (HOUB) in accordance with Good Clinical Practice principles, applicable regulatory requirements, and ethical standards for research involving human participants.
研究类型
注册 (估计的)
阶段
- 第四阶段
联系人和位置
学习联系方式
- 姓名：José López-López, Doctor
- 电话号码：0034-606457362
- 邮箱：jl.lopez@ub.edu
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion criteria Adults aged 18 years or older. Able to perform daily oral hygiene independently. Presence of at least 20 natural teeth and/or implant-supported restorations. Patients attending the Master of Oral Medicine, Oral Surgery and Oral Implantology clinics at the Hospital Odontològic Universitat de Barcelona (HOUB).
Willing and able to comply with study procedures and follow-up visits. Provision of written informed consent.
Exclusion Criteria:
Moderate or severe periodontitis requiring immediate treatment. Fixed orthodontic appliances. Use of systemic antibiotics or antiseptic mouthwashes (e.g., chlorhexidine) within 4 weeks prior to enrollment.
Pregnancy or breastfeeding. Participants unable to cooperate with study procedures due to psychomotor dysfunction or behavioral disorders.
学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：sonic toothbrush
Participants will be instructed to brush their teeth twice daily for 2 minutes using the assigned sonic toothbrush.
Standardized oral hygiene instructions will be provided at the beginning of the phase
|
Participants will use a powered sonic toothbrush for 3 weeks as part of a randomized crossover study.
Subjects will be instructed to brush twice daily (morning and evening) for 2 minutes using a standardized fluoridated toothpaste provided by the investigators.
Standardized oral hygiene instructions will be given at the beginning of each intervention period.
No antiseptic mouthwashes or additional intensive oral hygiene devices will be allowed during the study period.
|
|
有源比较器：Oscillating toothbrush
Participants will be instructed to brush their teeth twice daily for 2 minutes using the assigned oscillating-rotating electric toothbrush .
Standardized oral hygiene instructions will be provided at the beginning of the phase
|
Participants will use a powered sonic toothbrush for 3 weeks as part of a randomized crossover study.
Subjects will be instructed to brush twice daily (morning and evening) for 2 minutes using a standardized fluoridated toothpaste provided by the investigators.
Standardized oral hygiene instructions will be given at the beginning of each intervention period.
No antiseptic mouthwashes or additional intensive oral hygiene devices will be allowed during the study period.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Plaque Index (O'Leary Plaque Control Record)
大体时间：Baseline and after each 3-week intervention period (up to 9 weeks).
|
Change in the percentage of tooth surfaces with dental plaque, assessed using the O'Leary Plaque Control Record.
Plaque presence will be recorded on four surfaces of each tooth after application of a plaque-disclosing agent.
Results will be expressed as the percentage of surfaces with plaque.
|
Baseline and after each 3-week intervention period (up to 9 weeks).
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Gingival Bleeding Index
大体时间：Baseline and after each 3-week intervention period (up to 9 weeks).
|
Change in gingival inflammation assessed using the Silness and Löe Gingival Index, based on color changes, edema, and bleeding on probing.
|
Baseline and after each 3-week intervention period (up to 9 weeks).
|
|
Salivary pH
大体时间：Baseline and after each 3-week intervention period (up to 9 weeks).
|
Change in salivary pH measured using pH indicator strips applied to unstimulated saliva samples collected under standardized conditions
|
Baseline and after each 3-week intervention period (up to 9 weeks).
|
|
Unstimulated Salivary Flow Rate
大体时间：Baseline and after each 3-week intervention period (up to 9 weeks).
|
Change in unstimulated salivary flow rate (mL/min), measured by collecting saliva for 5 minutes in a sterile container.
|
Baseline and after each 3-week intervention period (up to 9 weeks).
|
|
Total Bacterial Load (16S rRNA Quantification)
大体时间：Baseline and after each 3-week intervention period (up to 9 weeks).
|
Change in total salivary bacterial load determined by quantitative PCR (qPCR) quantification of the bacterial 16S rRNA gene, expressed as copies per mL of saliva.
|
Baseline and after each 3-week intervention period (up to 9 weeks).
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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