Clinical Study on Malodor

Oral Malodor Clinical Trial

Official title:

Clinical Investigation on Oral Malodor for a New Formula of Stannous Toothpaste as Compared to Colgate Cavity Protection Toothpaste Using Organoleptic Method

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06300905
• Other study ID #: CRO-2023-05-OMO-SNA-YPZ
• Status: Completed
• Phase: Phase 3
• Start date: June 1, 2023
• Est. completion date: July 2, 2023

Study information

• Verified date: March 2024
• Source: Colgate Palmolive
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 2, 2023
• Est. primary completion date: July 2, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Oral Malodor

Intervention

Drug:
• test product
toothpaste containing 0.45% stannous fluoride
• Control product
toothpaste containing 0.76% sodium monofluorophosphate

Locations

Country	Name	City	State
China	West China Dental Institute of Chengdu	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
Colgate Palmolive

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Organoleptic Oral Malodor Evaluations	The measured levels of oral malodor will be expressed in organoleptic scales (1-9)	Oral malodor evaluations at baseline & 3 weeks