Clinical Research Study to Assess the Efficacy of Two Brushing Regimens in the Reduction of Established Dental Plaque and Gingivitis.

Clinical Research Study to Assess the Efficacy of Two Brushing Regimens: 1) a Toothpaste Containing Stannous Fluoride With a Mouthwash Containing Cetylpyridinium Chloride and a Manual Toothbrush as Compared to 2) a Regular Fluoride Toothpaste and Standard Manual Toothbrush in the Reduction of Established Dental Plaque and Gingivitis.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06244303

Enrollment

Registered

2024-02-06

Start date

2024-01-22

Completion date

2024-04-16

Last updated

2026-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gingivitis, Plaque

Keywords

Loe and Silness Gingival Index, Quigley and Hein Plaque Index

Brief summary

Qualified subjects will be enrolled and randomized to one of the two study groups based on their initial Plaque and Gingivitis scores. Subjects will be instructed to use the products according to the instructions provided. Subjects will return to the dental office for evaluation after 1-, 3-, 6-, and 12-weeks of unsupervised product use at home. All subjects will be followed for adverse events throughout the study

Interventions

DRUGmanual Tooth Brush + Colgate Total TP (0.454% SnF, 1100 ppm F)

Toothpaste, toothbrush \& mouthwash regime

DRUGmanual toothbrush + Colgate dental cream

toothpaste + toothbrush

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Yes

Inclusion criteria

* Signed Informed Consent Form. * Male and female subjects aged 18-70 years, inclusive. * Availability for the twelve-week 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)

Exclusion criteria

* Presence of orthodontic appliances. * Presence of partial removable dentures. * Tumor(s) of the soft or hard tissues of the oral cavity. * Moderate and/or advanced periodontal disease, rampant caries, or any condition that the dental examiner considers exclusionary from the study. * 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

Design outcomes

Primary

Measure	Time frame	Description
Quigley and Hein Plaque Index	Baseline, 1-, 3-, 6-, and 12-week	reductions in dental plaque
Loe and Silness Gingival Index	Baseline, 1-, 3-, 6-, and 12-week	reductions in gingivitis

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORFarid Ayad, B.D.S., D.D.S., MSC

FAR Oral and Systemic Health Consulting, Inc

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 20, 2026