360-degree mouth-cleaner manual toothbrush versus standard flat-trim manual toothbrush for reducing mouth bacteria
Evaluate the Effectiveness of Whole Mouth Bacterial Reduction for a Manual Toothbrush With a 360-Degree Mouth Cleaner Design Versus a Standard Flat-Trim Manual Toothbrush.
This test looks at whether a 360-degree mouth-cleaner manual toothbrush reduces whole-mouth bacteria more than a standard flat-trim manual toothbrush in adults 18–65 with at least 20 natural teeth.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Colgate Palmolive Industry-sponsored |
| Locations | 1 site (Heredia) |
| Trial ID | NCT07471477 on ClinicalTrials.gov |
What this trial studies
Adult participants in good general and oral health are assigned to use either a 360-degree mouth-cleaner manual toothbrush (test) or a standard flat-trim manual toothbrush (control), both with 0.76% sodium monofluorophosphate (1000 ppm F). Saliva samples are collected before brushing (baseline) and at 30 minutes and 2 hours after brushing to measure bacterial load by change in log CFU/mL. The primary comparison is the change in whole-mouth bacterial counts between the test and control toothbrushes at those post-brushing time points. Participants must be able to attend the site and comply with at-home procedures and sampling.
Who should consider this trial
Good fit: Adults aged 18–65 in good general and oral health with at least 20 permanent natural teeth who can attend study visits and follow at-home procedures.
Not a fit: People with moderate-to-advanced periodontal disease, clinically evident oral tumors, fixed or removable orthodontic appliances, or removable partial dentures were excluded and may not benefit from the results.
Why it matters
Potential benefit: If successful, the 360-degree toothbrush could lower mouth bacteria after brushing and may help reduce short-term plaque buildup and bacterial exposure.
How similar studies have performed: Previous toothbrush-design studies have shown modest differences in plaque and bacterial reduction, but specific clinical data on 360-degree mouth-cleaner designs are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Provide written, voluntary Informed Consent prior to any study-related procedures. * Be male or female subjects aged 18 to 65 years, inclusive. * Be available for the entire duration of the clinical research study, including all scheduled visits and compliance with at-home procedures * Be in good general health with an appropriate oral health status, based on the medical/dental history and the clinical opinion of the study investigator or dental examiner. -Have a minimum of 20 permanent, natural, uncrowned teeth (excluding third molars) Exclusion Criteria: * Current Orthodontic Treatment: Presence of any fixed or removable orthodontic appliances (e.g., braces, aligners with attachments, retainers). * Prosthetics: Presence of partial removable dentures. * Oral Pathology: Clinically evident benign or malignant neoplasms (tumors) of the oral mucosa, gingiva, palate, tongue, floor of the mouth, or jaw. * Periodontal Status: Diagnosis of moderate to advanced periodontitis, defined by periodontal charting (e.g., Clinical Attachment Loss \[CAL\] ≥ 3mm or Probing Depths \[PD\] ≥ 5mm in multiple sites). * Carious Lesions: Presence of rampant caries (widespread, rapidly progressive lesions) or ≥ 5 active carious lesions (cavitated or non-cavitated) judged by the investigator to require immediate restorative care. * Recent Antibiotic Use: Use of any systemic antibiotic medication within 30 days prior to the screening or baseline visit. * Recent Dental Prophylaxis: Received a professional dental cleaning (including hand/ultrasonic scaling and/or polishing) within 14 days prior to the baseline visit. * Interfering Medications: Current use of prescription medications that, in the investigator's opinion, could interfere with study outcomes by affecting the oral microbiome, salivary flow, or inflammation (e.g., long-term antimicrobials, xerogenic medications). * Fasting Inability: Inability or unwillingness to comply with the fasting requirement (refraining from all food and drink, other than plain water, for up to 4 hours) required for on-site visits. * Substance Abuse: Documented history or investigator-assessed ongoing substance misuse that could impact study compliance or subject safety. * Pregnancy or Lactation: Subjects who are pregnant or currently lactating (breastfeeding), based on self-report at screening. * Tobacco/Nicotine Use: Any current use of tobacco, nicotine, or e-cigarette products (including combustible cigarettes, smokeless tobacco, vaping, or nicotine replacement therapy). * Concurrent Study Participation: Participation in any other interventional or observational clinical study within the past 30 days that could confound the results of this trial.
Where this trial is running
Heredia
- M Clinical — Heredia, Costa Rica (Recruiting)
Study contacts
- Study coordinator: Mauricio Monntero-Aguilar, DDS, MSc
- Email: mmontero@mclinical.co
- Phone: (506) 7114 8540
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.