Clinical Study on Malodor

Phase 3

Completed

• Conditions: Oral Malodor
• Interventions: Drug: test product; Drug: Control product

• Registration Number: NCT06300905
• Lead Sponsor: Colgate Palmolive

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-01
• Primary Completion: 2023-07-02
• Study Completion: 2023-07-02
• Status Verified: 2024-03
• Study First Submitted: 2024-03-03
• Study First Submitted QC: 2024-03-03
• Last Update Submitted: 2024-03-03
• Study First Posted: 2024-03-08
• Last Update Posted: 2024-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group I	test product	Brushing twice daily in the morning and evening with 2 minutes each time
Group I	Control product	Brushing twice daily in the morning and evening with 2 minutes each time
Group II	test product	Brushing twice daily in the morning and evening with 2 minutes each time
Group II	Control product	Brushing twice daily in the morning and evening with 2 minutes each time

Primary Outcome Measures

Name	Time	Method
Organoleptic Oral Malodor Evaluations	Oral malodor evaluations at baseline & 3 weeks	The measured levels of oral malodor will be expressed in organoleptic scales (1-9)

Trial Locations

Locations (1)

West China Dental Institute of Chengdu; 🇨🇳 Chengdu, Sichuan, China