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CompletedNCT06486974Updated Mar 19, 2026

Efficacy of Manual Toothbrushes in Removing Tooth Stains

A Phase 3 interventional study of NaF and Na MFP in Tooth Discoloration, sponsored by Colgate Palmolive. Completed at 1 site in Dominican Republic. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-19.

Sponsored by Colgate Palmolive · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Nov 2024, 1 year 11 months ago, and no results have been posted to the registry.
Phase
Phase 3
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

Efficacy of Manual Toothbrushes in Removing Tooth Stains: A 6-Week Clinical Research Study.

Read the detailed description

The aim of this study is to evaluate the effectiveness of manual toothbrushes in reducing tooth staining after 6 weeks of unsupervised, daily use by participants.

02

Conditions studied

  • Tooth Discoloration

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Keywords

  • Lobene Tooth Stain Index
03

In context

Tooth Discoloration

102 studies on the registry are indexed under Tooth Discoloration; 19 are open to participants now.

This study's enrollment of 80 is above the median of 48 across 95 interventional studies indexed under Tooth Discoloration.

Browse Tooth Discoloration studies →

Lead sponsor

Colgate Palmolive is the lead sponsor of 114 studies on the registry; 12 are open to participants now.

Of its 33 completed or terminated interventional studies of FDA-regulated products, 2 (6%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Signed Informed Consent Form;
  • Male and female subjects, aged 18-70, inclusive;
  • Good general health and good oral health based on the opinion of the study investigator;
  • Presence of permanent natural anterior teeth (no veneers/crowns/restorations that may interfere with this study scoring procedures);
  • A minimum composite mean of 1.5 ≥ determined by the Lobene Tooth Stain Index;
  • Available for the duration of the study;
  • Clinical evidence of a tendency to form extrinsic stains on anterior teeth.

Exclusion criteria

Exclusion Criteria:

  • Presence of orthodontic appliances/retainers involving scorable teeth;
  • Presence of partial removable/fixed dentures and/or restorations involving scorable teeth;
  • Tumor(s) of the soft or hard tissues of the oral cavity;
  • Obvious signs of periodontal disease rampant caries, or any condition that the dental examiner considers exclusionary from the study;
  • Five or more carious lesions requiring immediate care;
  • Use of antibiotics, stain-inducing medications, and/or on any prescription that might interfere with the study outcome;
  • Concurrent participation in another clinical study;
  • Self-reported pregnancy and/or lactating women;
  • Have used professional whitening product within one (1) year or had a dental prophylaxis (professional dental cleaning) within thirty (30) days - prior to the start of the study;
  • History of allergies to oral care/personal care consumer products or their ingredients;
  • History of alcohol and/or drug abuse.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
80 participants (actual)

Study arms

  • Experimental
    Group 1

    Colgate MaxFresh Toothpaste - 0.243% NaF (1100 ppm F) Total Polish 23 CHS TB Colgate Active Prevention Manual Toothbrush

    Drug: NaF

  • Active comparator
    Group 2

    Colgate Great Regular Flavor Toothpaste - 0.76% Na MFP (1000 ppm F) Colgate Adult Extra Clean soft-bristle toothbrush

    Drug: Na MFP

Interventions

  • DrugNaF

    Group 1 will be instructed to brush their teeth twice daily/2 minutes each time for the duration of this study

  • DrugNa MFP

    Group 2 will be instructed to brush their teeth twice daily/2 minutes each time for the duration of this study

06

What researchers measure

Primary outcomes

  1. Lobene Tooth Stain Index

    Each tooth will be scored separately using a 4 point area Stain Area (extent): (0) No stain detected 1. Stain covering up to one third (1/3) of the region 2. Stain covering \> 1/3 to 2/3 of the region 3. Stain covering \> 2/3 of the region Stain Intensity: (0) No stain 1. Light Stain - yellow to light brown or gray 2. Moderate stain - medium brown 3. Heavy stain - dark brown to black and intensity scale ranging from: Using the Lobene Tooth Stain Index, each tooth will be scored separately using a 4 point area and intensity scale ranging from:

    Time frame: Baseline, and 6-weeks

07

Study locations

1 site
  • Spa Dental
    Santo Domingo, Dominican Republic
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 19, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06486974
Lead sponsor
Colgate Palmolive
Responsible party
Sponsor
First posted
Jul 5, 2024
Start date
Sep 23, 2024
Primary completion
Nov 8, 2024
Completion
Nov 8, 2024
Last update
Mar 19, 2026

Study contacts

Franklin Garcia-Godoy, DDS, MS, PhD
principal investigator · Global Research Consultants

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.

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