NCT05916521

Brief Summary

The objective of the study is to evaluate the gingivitis control benefit of an established stannous fluoride containing toothpaste relative to a negative control dentifrice.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

November 15, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 11, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 11, 2022

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

June 14, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 23, 2023

Completed
Last Updated

June 23, 2023

Status Verified

June 1, 2023

Enrollment Period

3 months

First QC Date

June 14, 2023

Last Update Submit

June 14, 2023

Conditions

Gingivitis

Outcome Measures

Primary Outcomes (3)

  • Löe-Silness Gingivitis Evaluation

    Löe-Silness Gingivitis Evaluation is a validated assessment of gingival health looking at inflammation and bleeding based on a 4 point range 0 (normal gingiva) to 3 (severe inflammation).

    Baseline

  • Löe-Silness Gingivitis Evaluation

    Löe-Silness Gingivitis Evaluation is a validated assessment of gingival health looking at inflammation and bleeding based on a 4 point range 0 (normal gingiva) to 3 (severe inflammation).

    Week 4

  • Löe-Silness Gingivitis Evaluation

    Löe-Silness Gingivitis Evaluation is a validated assessment of gingival health looking at inflammation and bleeding based on a 4 point range 0 (normal gingiva) to 3 (severe inflammation).

    Week 12

Study Arms (3)

Positive Control

ACTIVE COMPARATOR

2 brushings per day (AM and PM)

Drug: 0.454% stannous fluoride

Negative Control

SHAM COMPARATOR

2 brushings per day (AM and PM)

Drug: 0.76% sodium monofluorophosphate

Experimental Control

EXPERIMENTAL

Brush with Positive control in the morning and negative control in the evening

Drug: 0.454% stannous fluoride AM and 0.76% sodium monofluorophosphate PM

Interventions

0.454% stannous fluorideDRUG

Brush two times daily

Positive Control
0.76% sodium monofluorophosphateDRUG

Brush two times daily

Negative Control
0.454% stannous fluoride AM and 0.76% sodium monofluorophosphate PMDRUG

Brush two times daily

Experimental Control

Eligibility Criteria

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

You may qualify if:

  • Be at least 18 years of age;
  • Provide written informed consent prior to participation and be given a signed copy of the informed consent form;
  • Be in general good health as determined by the Investigator based on a review of the health history/update for participation in the trial;
  • Have at least 20 gradable teeth;
  • Have established gingivitis with 10-70% bleeding sites;
  • Agree to return for scheduled visits and follow the study procedures;
  • Agree to refrain from use of any non-study oral hygiene products for the duration of the study;
  • Agree to delay any elective dentistry, including dental prophylaxis, until the completion of the study.

You may not qualify if:

  • Having taken medications (antibiotic, anti-inflammatory, or anti-coagulant) which could alter gingival bleeding within 4 weeks of the Baseline Visit;
  • Having any oral conditions that could interfere with study compliance and/or examination procedures, such as widespread caries, soft or hard tissue tumor of the oral cavity, or advanced periodontal disease;
  • Having known hypersensitivity to the test products;
  • Having removable oral appliances;
  • Having fixed facial or lingual orthodontic appliances;
  • Self-reported pregnancy or lactation;
  • Having any diseases or condition that might interfere with the safe participation in the study;
  • Having an inability to undergo study procedures.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Silverstone Research Group

Las Vegas, Nevada, 89146, United States

Location

Related Publications (1)

  • He T, Zou Y, Grender J, Amini P, Kaminski M, Biesbrock AR. Randomized Controlled Trials Assessing Exposure Frequency Effects of Stannous Fluoride on Gingivitis. JDR Clin Trans Res. 2025 Apr;10(2):124-134. doi: 10.1177/23800844241263031. Epub 2024 Aug 8.

    PMID: 39118360DERIVED

MeSH Terms

Conditions

Gingivitis

Interventions

Tin Fluoridesfluorophosphate

Condition Hierarchy (Ancestors)

InfectionsGingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

FluoridesHydrofluoric AcidFluorine CompoundsInorganic ChemicalsTin CompoundsCariostatic AgentsBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and Agriculture

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 14, 2023

First Posted

June 23, 2023

Study Start

November 15, 2021

Primary Completion

February 11, 2022

Study Completion

February 11, 2022

Last Updated

June 23, 2023

Record last verified: 2023-06

Locations

US(1)