NCT07605338

Brief Summary

Triple Blinded Randomized Clinical trial study to assess the efficacy of two brushing regimens: 1) a toothpaste containing stannous fluoride and a standard manual toothbrush as compared to 2) a regular fluoride toothpaste and standard manual toothbrush in the reduction of established dental plaque and gingivitis.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
85

participants targeted

Target at below P25 for phase_3

Timeline
6mo left

Started May 2026

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress7%
May 2026Nov 2026

Study Start

First participant enrolled

May 11, 2026

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

May 18, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 22, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Last Updated

May 22, 2026

Status Verified

May 1, 2026

Enrollment Period

6 months

First QC Date

May 18, 2026

Last Update Submit

May 18, 2026

Conditions

Plaque, DentalGingivitis

Outcome Measures

Primary Outcomes (2)

  • Loe-Silness Gingival Index

    score from 0 to 3 will be assigned by the examining dentist Each tooth is scored on six surfaces: mesio-facial; 2) mid-facial; 3) disto-facial; 4) mesiolingual; 5) mid-lingual; and 6) disto-lingual

    baseline, 12 weeks, 24 weeks

  • Quigley-Hein Plaque Index

    score of 0 to 5 will be assigned to all scoreable disclosed surfaces of the maxillary and mandibular teeth. Each tooth is scored for supragingival plaque on six surfaces: mesio-facial; 2) mid-facial; 3) disto-facial; 4) mesio-lingual; 5) mid-lingual; and 6) disto-lingual

    baseline, 12 weeks, 24 weeks

Study Arms (2)

Test 1 toothpaste

EXPERIMENTAL

Colgate SNaP Total 10/10, 1.5 Taurate

Drug: Colgate SNaP Total 10/10, 1.5 TaurateOther: Flat Trimmed Extra Clean TB

Control toothpaste

ACTIVE COMPARATOR

Colgate Great Regular Flavor Toothpaste

Drug: Colgate Great Regular Flavor ToothpasteOther: Flat Trimmed Extra Clean TB

Interventions

Colgate SNaP Total 10/10, 1.5 TaurateDRUG

0.454% SnF 1100 ppm F , 1.5 Taurate

Test 1 toothpaste
Colgate Great Regular Flavor ToothpasteDRUG

0.76% Na MFP, (1000 ppm F)

Control toothpaste
Flat Trimmed Extra Clean TBOTHER

manual toothbrush

Control toothpasteTest 1 toothpaste

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Signed Informed Consent Form.
  • Male and female subjects aged 18-70 years, inclusive.
  • Availability for the twenty four-week(6 month) duration of the clinical research study.
  • Good general health based on the opinion of the study investigator
  • Minimum of 20 permanent natural teeth (excluding third molars).
  • 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)

You may not qualify if:

  • Presence of orthodontic appliances.
  • Presence of partial removable dentures.
  • Tumor(s) of the soft or hard tissues of the oral cavity.
  • 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 and/or drinking for periods up to 4 hours.
  • History of alcohol and/or drug abuse.
  • Self-reported pregnancy and/or lactating subjects

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mesa Dental Centre

Costa Mesa, California, 92627, United States

Location

MeSH Terms

Conditions

Dental PlaqueGingivitis

Condition Hierarchy (Ancestors)

Dental DepositsTooth DiseasesStomatognathic DiseasesInfectionsGingival DiseasesPeriodontal DiseasesMouth Diseases

Study Design

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

Study Record Dates

First Submitted

May 18, 2026

First Posted

May 22, 2026

Study Start

May 11, 2026

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2026

Last Updated

May 22, 2026

Record last verified: 2026-05

Locations

US(1)