Bacterial Reduction for a Manual Toothbrush With a 360-Degree Mouth Cleaner Design Versus a Stand… (NCT07471477) | Clinical Trial Compass
RecruitingPhase 3
Bacterial Reduction for a Manual Toothbrush With a 360-Degree Mouth Cleaner Design Versus a Standard Toothbrush
Costa Rica60 participantsStarted 2026-03-01
Plain-language summary
The objective of this study is to determine and compare the effectiveness of a manual toothbrush with a 360-degree mouth cleaner design versus a standard flat-trim manual toothbrush in achieving whole mouth bacterial load reduction
Who can participate
Age range18 Years – 65 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 Prophylaxi…
What they're measuring
1
measure whole mouth bacterial load (measured as LOG CFU/mL) by collecting saliva samples
Timeframe: Pre- brushing Baseline, 30 minutes Post-Brushing, and 2 hours Post-Brushing only during the supervised, on-site brushing session for the Test Product and Control product treatment period