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

NCT07471477 | Completed Phase 3

• 1 other identifier: CRO-2026-02-SAL-360MTB-CR-BGS
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Bacterial Load Reduction

Outcome Measures

Primary Outcomes (1)

• measure whole mouth bacterial load (measured as LOG CFU/mL) by collecting saliva samples

  Change is calculated by comparing the bacterial counts at the Pre-brushing Baseline time point against the bacterial counts at the two post- brushing time points: 30 minutes Post-Brushing and 2 hours Post-Brushing when using Test product and then Control product

  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

Study Arms (2)

Test 1 toothbrush

EXPERIMENTAL

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

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

Control toothbrush

ACTIVE COMPARATOR

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

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

Interventions

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

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

Control toothbrush

Colgate 360 SupraClean Manual 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) toothpaste single, supervised on-site use (2- minute brushing) w/ approx. 1.2g full ribbon

Test 1 toothbrush

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Colgate Palmolive: lead

Study Sites (1)

M Clinical

Heredia, 40101, Costa Rica

Location

MeSH Terms

Interventions

Supersmile

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2026
• First Posted: March 13, 2026
• Study Start: March 1, 2026
• Primary Completion: June 6, 2026
• Study Completion: June 6, 2026
• Last Updated: June 12, 2026

Record last verified: 2026-06

Locations

CO (1)