Efficacy of a Eugenol-based Product to Improve the Quality of Toothbrushing and Relieving Gum Discomfort Areas

Colgate-Palmolive

Status and phase

Completed

Phase 3

Conditions

Plaque, Dental

Treatments

Drug: fluoride toothpaste containing 1450 ppm of MFP in a PCC base and eugenol gum product

Drug: fluoride toothpaste containing 1450 ppm of MFP in a PCC base

Study type

Interventional

Funder types

Industry

Identifiers

NCT06366568

CRO-2022-10-PG-MER-MW-JG

Details and patient eligibility

About

The objective of this study is to evaluate the efficacy of a eugenol-based product in improving the quality of toothbrushing and relieving areas of gingival discomfort. This is a randomized, controlled, parallel, examiner-blind clinical trial.

Enrollment

86 patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

You must provide consent to participate by signing this informed consent form.
Available for the two(2) week study duration.
You must be at least eighteen(18) years old and not older than seventy(70) years of age.
You must not smoke.
You must be in good general health for participation in the study, based on the opinion of the study investigator.
You must have at least 20 natural permanent teeth.
Your teeth must meet the scoring entry criteria for dental plaque and gingivitis(gum inflammation) at the discretion of the study examiner.
You must meet the scoring criteria for gum discomfort, determined using your responses to the survey questionnaire.
You must have no known history of allergy to personal care/consumer products or their ingredients, relevant to any ingredients in the test products as determined by the study examiner.

Exclusion criteria

Medical condition which requires premedication prior to dental visits/procedures.
Presence of fix/ removable prosthodontics dentures that may interfere with this study clinical examinations.
Advanced periodontal disease (gum disease) and/or treatment for periodontal disease (including surgery) within the past twelve months.
Five (5) or more decayed, untreated dental sites (cavities) and/or any dental condition requiring urgent dental care.

Abnormalities/diseases of the soft or hard oral tissues.

Orthodontic appliances/bands/lingual bars that interfere with any clinical assessment (plaque scoring)
Current smokers and/or tobacco users and/or a history of alcohol or drug abuse.
Use of drugs that can affect salivary flow.
Use of antibiotics one (1) month prior to study entry and/or during participation in this study.
Use of any over the counter medications other than analgesics that could interfere with the study at PI discretion.
Self-reported pregnancy and/or breastfeeding.
Current Participation in another clinical study or during the month prior to this clinical study entry.
Known allergies and/or reactions to common dentifrice ingredients.
Medical condition which prohibits not eating/drinking or chewing gum for four (4) hours prior to your scheduled visits.
Immunocompromised conditions (AIDS, immunosuppressive drug therapy).
Infectious disease and/or other blood borne diseases (Hepatitis series, HIV, tuberculosis).