NCT06140784

Brief Summary

The primary objective of this study is to evaluate the effect four different dentifrices have on gingivitis after 12 weeks of product use. The secondary objectives are to assess the effect four dentifrices, have on plaque and oral microbiome composition.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
116

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2023

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

September 2, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 14, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 20, 2023

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2023

Completed
Last Updated

March 1, 2024

Status Verified

February 1, 2024

Enrollment Period

3 months

First QC Date

November 14, 2023

Last Update Submit

February 29, 2024

Conditions

Gingivitis

Outcome Measures

Primary Outcomes (1)

  • 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).

    3 Months

Secondary Outcomes (5)

  • Löe-Silness Gingivitis Evaluation

    Baseline

  • Löe-Silness Gingivitis Evaluation

    1 Month

  • Mean Turesky Modified Quigley-Hein Index

    Baseline

  • Mean Turesky Modified Quigley-Hein Index

    1 Month

  • Mean Turesky Modified Quigley-Hein Index

    3 Months

Study Arms (4)

0.76% Sodium Monofluorophosphate Dentifrice

SHAM COMPARATOR
Drug: 0.76% Sodium Monofluorophosphate Dentifrice

Marketed 0.454% Stannous Fluoride plus Arginine Dentifrice

ACTIVE COMPARATOR
Drug: 0.454% Stannous Fluoride Dentifrice

Marketed 0.454% Stannous Fluoride Dentifrice

ACTIVE COMPARATOR
Drug: 0.454% Stannous Fluoride Dentifrice

0.454% Stannous Fluoride Dentifrice

ACTIVE COMPARATOR
Drug: 0.454% Stannous Fluoride Dentifrice

Interventions

0.76% Sodium Monofluorophosphate DentifriceDRUG

Whole mouth brushing with a toothpaste, twice daily for the duration of the study.

0.76% Sodium Monofluorophosphate Dentifrice
0.454% Stannous Fluoride DentifriceDRUG

Whole mouth brushing with a toothpaste, twice daily for the duration of the study.

Marketed 0.454% Stannous Fluoride plus Arginine Dentifrice

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 16 gradable teeth;
  • Have mild to moderate gingivitis with at least 20 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;
  • Agree to refrain from any oral hygiene the morning of your visit
  • Agree to refrain from eating, drinking (except water), using tobacco, floss, use toothpicks, breath mints, or chew gum after performing your evening brushing.

You may not qualify if:

  • Having taken antibiotic, anti-inflammatory, or anti-coagulant medications within 4 weeks of the Baseline Visit;
  • Have 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 had a dental prophylaxis within 2 weeks of plaque sampling visits;
  • Removable oral appliances;
  • Fixed facial or lingual orthodontic appliances;
  • Self-reported pregnancy or lactation;
  • Any diseases or condition that might interfere with the safe participation in the study; and
  • Inability to undergo study procedures.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UHRG

Whittier, California, 90602, United States

Location

MeSH Terms

Conditions

Gingivitis

Condition Hierarchy (Ancestors)

InfectionsGingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Design

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

Study Record Dates

First Submitted

November 14, 2023

First Posted

November 20, 2023

Study Start

September 2, 2023

Primary Completion

December 10, 2023

Study Completion

December 10, 2023

Last Updated

March 1, 2024

Record last verified: 2024-02

Locations

US(1)