NCT07211061

Brief Summary

Subjects who have shown evidence of gingivitis and plaque will be enrolled in this study. Each subject will be randomly assigned to one of two treatment products. The regimen group will be asked to brush 2x a day in using a power brush (2 minutes of brushing), followed by using 20 ml of mouth rinse for 30 seconds for 6 weeks. The negative control group will be asked to brush 2x a day using a manual toothbrush in their customary manner for 6 weeks. Oral Soft Tissue (OST) assessments, gingivitis and plaque measurements will be taken at 4 time-points: Baseline (BL); Week 1; Week 3; and Week 6.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
69

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Sep 2011

Shorter than P25 for phase_4

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 21, 2011

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 10, 2011

Completed
13.9 years until next milestone

First Submitted

Initial submission to the registry

September 29, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 7, 2025

Completed
Last Updated

October 7, 2025

Status Verified

September 1, 2025

Enrollment Period

2 months

First QC Date

September 29, 2025

Last Update Submit

September 29, 2025

Conditions

Gingivitis

Outcome Measures

Primary Outcomes (1)

  • Bleeding (GBI)

    Gingival Bleeding Index- evaluation of bleeding from gingival tissue, score from 0-2

    Week 1, Week 3, and Week 6

Secondary Outcomes (1)

  • Inflammation (MGI)

    Week 1, Week 3, and Week 6

Study Arms (2)

Oral Hygiene Regimen

EXPERIMENTAL

toothpaste, electric toothbrush, and mouth rinse

Drug: Stannous Fluoride DentifriceDevice: electric toothbrushDrug: Cetylpyridinium Chloride (CPC)

Negative Control

ACTIVE COMPARATOR

toothpaste and manual toothbrush

Drug: Sodium Fluoride DentifriceDevice: manual toothbrush

Interventions

Stannous Fluoride DentifriceDRUG

brush 2x a day in using a power brush (2 minutes of brushing)

Oral Hygiene Regimen
Sodium Fluoride DentifriceDRUG

brush in their customary manner

Negative Control
electric toothbrushDEVICE

brush using a electric brush (2 minutes of brushing)

Oral Hygiene Regimen
Cetylpyridinium Chloride (CPC)DRUG

use 20 ml of mouth rinse for 30 seconds

Oral Hygiene Regimen
manual toothbrushDEVICE

brush in their customary manner

Negative Control

Eligibility Criteria

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

You may qualify if:

  • Provide written informed consent to participate in the study;
  • Be 18 years of age or older;
  • Agree not to participate in any other oral/dental product studies during the course of this study;
  • Agree to delay any elective dentistry (including dental prophylaxis) until the study has been completed;
  • Agree to refrain from any form of non-specified oral hygiene during the treatment periods, including but not limited to the use of products such as floss or whitening products;
  • Have a Baseline MGI score of at least 1.75 but not greater than 2.3;
  • Have at least 20 bleeding sites (sites with a score of 1 or 2 on the GBI index);
  • Agree to return for all scheduled visits and follow study procedures;
  • Be in good general health, as determined by the Investigator/designee based on a review of the health history/update for participation in the study.

You may not qualify if:

  • Have had a dental prophylaxis within 2 weeks of Baseline visit;
  • Have taken antibiotics or used anti-gingivitis / anti-bacterial oral care products such as chlorhexidine or Listerine within 2 weeks of plaque sampling visits;
  • Have rampant caries, open or untreated caries, severe gingivitis, or advanced periodontitis requiring prompt treatment; or,
  • Need an antibiotic prophylaxis prior to dental visits,
  • Present with any disease or condition(s) that could be expected to interfere with examination procedures or the subject's safe completion of the study,
  • Are pregnant (Self-reported) or lactating.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bio-Sci Research (Out of Business)

Las Vegas, Nevada, 89121, United States

Location

MeSH Terms

Conditions

Gingivitis

Interventions

Cetylpyridinium

Condition Hierarchy (Ancestors)

InfectionsGingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Pyridinium CompoundsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 4
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

September 29, 2025

First Posted

October 7, 2025

Study Start

September 21, 2011

Primary Completion

November 10, 2011

Study Completion

November 10, 2011

Last Updated

October 7, 2025

Record last verified: 2025-09

Locations

US(1)