Bacterial Reduction for a Manual Toothbrush With a 360-Degree Mouth Cleaner Design Versus a Standard Toothbrush

Colgate-Palmolive

Status and phase: Enrolling; Phase 3

Conditions: Bacterial Load Reduction

Treatments: Drug: Colgate Adult Extra Clean soft-bristle toothbrush brush with 0.76% Na MFP, (1000 ppm F); Drug: Colgate 360 SupraClean Manual Toothbrush brush with 0.76% Na MFP, (1000 ppm F)

Study type: Interventional

Funder types: Industry

Identifiers

NCT07471477

CRO-2026-02-SAL-360MTB-CR-BGS

Details and patient eligibility

About

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

Full description

The Primary Objective of this study is to determine and compare the effectiveness of a manual toothbrush with a 360-degree mouth cleaner design (Test Product) versus a standard flat-trim manual toothbrush (Control Product) in achieving whole mouth bacterial load reduction in adult subjects, as measured by the change in LOG CFU/mL of saliva from Pre-brushing Baseline to 30 minutes and 2 hours Post-Brushing

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

---

60 participants in 2 patient groups

Test 1 toothbrush

Experimental group

Description:

Colgate 360 SupraClean Manual Toothbrush brush with 0.76% Na MFP, (1000 ppm F) toothpaste single, supervised on-site use (2- minute brushing) w/ approx. 1.2g full ribbon

Treatment:

Drug: Colgate 360 SupraClean Manual Toothbrush brush with 0.76% Na MFP, (1000 ppm F)

Control toothbrush

Active Comparator group

Description:

Colgate Adult Extra Clean soft-bristle toothbrush brush with 0.76% Na MFP, (1000 ppm F) toothpaste single, supervised on-site use (2- minute brushing) w/ approx. 1.2g full ribbon

Treatment:

Drug: Colgate Adult Extra Clean soft-bristle toothbrush brush with 0.76% Na MFP, (1000 ppm F)