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

June 10, 2026 updated by: Colgate Palmolive

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
56

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Costa Rica
      • Heredia, Costa Rica, 40101
        • M Clinical

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
measure whole mouth bacterial load (measured as LOG CFU/mL) by collecting saliva samples
Time Frame: 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
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Colgate Palmolive

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2026

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 6, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 6, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 10, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 10, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 13, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 10, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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