Clinical Study on Malodor

Colgate-Palmolive

Status and phase: Completed; Phase 3

Conditions: Oral Malodor

Treatments: Drug: Control product; Drug: test product

Study type: Interventional

Funder types: Industry

Identifiers

NCT06300905

CRO-2023-05-OMO-SNA-YPZ

Details and patient eligibility

About

This 3-week clinical study was designed to investigate the clinical efficacy on oral malodor of a 0.454% stannous fluoride toothpaste with nitrate and pyrophosphate (referred to as SNAP) compared to Colgate Cavity Protection Toothpaste containing 0.76% sodium monofluorophosphate 12 hours post-brushing after 3 weeks of product use.

Enrollment: 100 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Must be male or female 18 to 70 years of age
• Must be in good general health
• Must be in good oral health based on self-assessment
• Must be available during the weeks of this study for all appointment time points
• Should have a minimum of 20 natural uncrowned teeth (excluding third molars)
• Should have a baseline mean oral malodor score greater than or equal to 6.0 and less than or equal to 8.0
• Must give written informed consent
• No known history of allergy to personal care/consumer products or their ingredients

Exclusion criteria

• Participation in any other oral clinical studies for the duration of this study
• Full or partial (upper or lower) dentures
• Pregnant or lactating (breast feeding)
• Use of tobacco products
• History of allergy to common toothpaste ingredients
• Use of phenolic flavored products, such as mint flavored candies and chewing gum, the morning of the study and during the sampling periods
• Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)
• Individuals who, due to medical conditions, cannot go without eating or drinking for the post use treatment evaluation time points (6 hrs. + overnight)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

Group I

Experimental group

Description:

Brushing twice daily in the morning and evening with 2 minutes each time

Treatment:

Drug: test product

Drug: Control product

Group II

Active Comparator group

Description:

Brushing twice daily in the morning and evening with 2 minutes each time

Treatment:

Drug: test product

Drug: Control product