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

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.

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

Study Overview

• Status: Recruiting
• Conditions: Bacterial Load Reduction
• Intervention / Treatment: Drug: Colgate 360 SupraClean Manual 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)

Detailed 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

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Mauricio Monntero-Aguilar, DDS, MSc; Phone Number: (506) 7114 8540; Email: mmontero@mclinical.co

Study Locations

• Costa Rica
  • Heredia, Costa Rica, 40101
    • Recruiting
    • M Clinical
    • Contact: Mauricio Montero-Aguilar, DDS, MSc; Phone Number: + (506) 7114 8540; Email: mmontero@mclinical.co

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test 1 toothbrush; 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); 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
Active Comparator: Control toothbrush; 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); 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Colgate Palmolive

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: March 10, 2026
• First Submitted That Met QC Criteria: March 10, 2026
• First Posted (Actual): March 13, 2026

Study Record Updates

• Last Update Posted (Actual): March 18, 2026
• Last Update Submitted That Met QC Criteria: March 16, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Supersmile
• Other Study ID Numbers: CRO-2026-02-SAL-360MTB-CR-BGS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No