A Clinical Study Conducted in the Bangkok, Thailand Area, to Investigate the Clinical Efficacy of a New Toothpaste

Colgate-Palmolive

Status and phase

Completed

Phase 3

Conditions

Oral Malodor

Treatments

Drug: 0.76% sodium monofluorophosphate

Drug: 0.454% stannous fluoride

Study type

Interventional

Funder types

Industry

Identifiers

NCT07223073

CRO-2017-10-OM-SNHW-THA-YPZ

Details and patient eligibility

About

To investigate the clinical efficacy of a new toothpaste containing 0.454% stannous fluoride as compared to a regular fluoride toothpaste containing 0.76% sodium monofluorophosphate on oral malodor reduction via organoleptic scores 12 hours post-brushing overnight after 3 weeks of twice a day (morning and evening) product use.

Enrollment

80 patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Male and female adults between the ages of 18-70 (inclusive)
Subjects must be in general good health
Subjects must be in good oral health based on self-assessment
Subjects must be available for the duration of the study for all time point assessments
Subjects were required to possess a minimum of 20 natural uncrowned teeth (excluding third molars)
Subjects were required to sign an Informed Consent form
No known history or allergies to personal care/consumer products or their ingredients.

Exclusion criteria

Participated in any other oral clinical studies during the duration of this study
Had full or partial (upper or lower) dentures
Women who are pregnant or lactating (breast feeding)
Use of tobacco products, (5) History of allergies to common mouthwash ingredients
Use of phenolic flavored products, such as mint flavored candies and chewing gum the morning of the study of during the sampling periods
Immune compromised individuals (HIV, AIDS, immune suppressive drug therapy
Individuals who, due to medical conditions cannot go without eating or drinking for the post use treatment evaluation time points (6-hours plus overnight).