Clinical Investigation to Assess the Efficacy of Manual Toothbrushes in the Reduction of Plaque and Gingivitis.

Colgate-Palmolive

Status and phase

Active, not recruiting

Phase 2

Conditions

Gingivitis

Plaque, Dental

Treatments

Drug: Control regimen

Drug: Test regimen

Study type

Interventional

Funder types

Industry

Identifiers

NCT06565897

CRO-2024-04-MTB-FL-DR

Details and patient eligibility

About

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, and 6, weeks of unsupervised product use at home. All subjects will be followed for adverse events throughout the study

Enrollment

84 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Signed Informed Consent Form.
Male and female subjects aged 18-70 years, inclusive.
Availability for the six-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 mean plaque index of at least 0.6 as determined by Navy Plaque index.

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.