CClinicalTrials.gg
CompletedNCT06427499Updated Mar 19, 2026

The Clinical of Stannous Fluoride Toothpaste and a Newly Designed Toothbrush Compared to Colgate Cavity Protection Toothpaste and a Regular Toothbrush in Reducing Plaque and Gingivitis.

A Phase 3 interventional study of Stannous fluoride toothpaste and Colgate Cavity Protection Toothpaste in Plaque and Gingivitis, sponsored by Colgate Palmolive. Completed at 1 site in Thailand. 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 Aug 2024, 2 years 2 months ago, and no results have been posted to the registry.
Phase
Phase 3
Study type
Interventional
Enrollment
95
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

Qualified subjects will be enrolled and randomly assigned to either of the two study groups based on their initial Plaque and Gingivitis scores. During the first visit, subjects will undergo three key procedures: 1) evaluation for baseline plaque and gingivitis, 2) brushing with the assigned regimen products for two minutes, and 3) assessment for post-brushing plaque only. Subjects will be provided with clear instructions for regimen product usage and will be expected to adhere to these instructions. Follow-up evaluations for plaque and gingivitis will be conducted at one week, six weeks, and three months after initiation of regimen product use. Throughout the study period, continuous monitoring for adverse events will be carried out for all subjects.

02

Conditions studied

  • Plaque
  • Gingivitis
03

In context

Plaque, Amyloid

89 studies on the registry are indexed under Plaque, Amyloid; 37 are open to participants now.

This study's enrollment of 95 is below the median of 110 across 63 interventional studies indexed under Plaque, Amyloid.

Browse Plaque, Amyloid 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

  • Subjects, ages 18-70, inclusive.
  • Availability for the three-month duration of the clinical research study.
  • Good general health.
  • Minimum of 20 uncrowned permanent natural teeth (excluding third molars). 5. Initial gingivitis index of at least 1.0 as determined by the use of the Loe and Silness Gingival Index.
  • Initial plaque index of at least 1.5 as determined by the use of the Quigley and Hein Plaque Index (Turesky Modification).
  • Signed Informed Consent Form

Exclusion criteria

Exclusion Criteria:

  • Presence of orthodontic bands.
  • Presence of partial removable dentures.
  • Tumor(s) of the soft or hard tissues of the oral cavity.
  • Advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone).
  • Five or more carious lesions requiring immediate restorative treatment.
  • Antibiotic use any time during the one-month period prior to entry into the study.
  • Participation in any other clinical study or test panel within the one month prior to entry into the study.
  • Dental prophylaxis during the past two weeks prior to baseline examinations.
  • History of allergies to oral care/personal care consumer products or their ingredients.
  • On any prescription medicines that might interfere with the study outcome.
  • An existing medical condition that prohibits eating or drinking for periods up to 4 hours.
  • History of alcohol or drug abuse.
  • Pregnant or lactating subjects
05

Study design

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

Study arms

  • Experimental
    Stannous Fluoride Toothpaste

    brush for 2 min, 2x/day, morning and night

    Drug: Stannous fluoride toothpaste

  • Active comparator
    Sodium monofluorophosphate toothpaste

    brush for 2 min, 2x/day, morning and night

    Drug: Colgate Cavity Protection Toothpaste

Interventions

  • DrugStannous fluoride toothpaste

    brush 2 min morning \& night daily

  • DrugColgate Cavity Protection Toothpaste

    brush 2 min morning \& night daily

06

What researchers measure

Primary outcomes

  1. Loe and Silness Gingival Index.

    A Loe-Silness Gingival Index score from 0 to 3 will be assigned by the examining dentist to all scoreable surfaces of the maxillary and mandibular teeth using a dental light and dental mirror. A whole mouth mean score for each subject will be determined by adding the values given by the examining dentist to each scoreable surface and dividing that number by the total number of surfaces scored.

    Time frame: baseline, one week, six weeks and three months

  2. Quigley and Hein Plaque Index

    A Quigley-Hein Plaque Index score of 0 to 5 will be assigned to all scoreable disclosed surfaces of the maxillary and mandibular teeth using a dental light and dental mirror. A whole mouth score for each subject will be determined by adding the values given by the dental examiner to each scoreable surface and dividing that number by the total number of surfaces scored.

    Time frame: baseline, one week, six weeks and three months

07

Study locations

1 site
  • Mahidol University
    Ratchathewi, Bangkok 10400, Thailand
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
NCT06427499
Lead sponsor
Colgate Palmolive
Responsible party
Sponsor
First posted
May 24, 2024
Start date
Apr 22, 2024
Primary completion
Aug 5, 2024
Completion
Aug 5, 2024
Last update
Mar 19, 2026

Study contacts

Terdphong Triratana
principal investigator · M U International Oral Science Research, Ltd

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 Mar 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion