Clinical Study on Malodor

NCT06300905 | Completed Phase 3

• 1 other identifier: CRO-2023-05-OMO-SNA-YPZ
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Oral Malodor

Keywords

Organoleptic method; oral malodor

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Group I

EXPERIMENTAL

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

Drug: test product; Drug: Control product

Group II

ACTIVE COMPARATOR

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

Drug: test product; Drug: Control product

Interventions

test product DRUG

toothpaste containing 0.45% stannous fluoride

Group I; Group II

Control product DRUG

toothpaste containing 0.76% sodium monofluorophosphate

Group I; Group II

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Colgate Palmolive: lead

Study Sites (1)

West China Dental Institute of Chengdu

Chengdu, Sichuan, 610041, China

Location

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Deyu Hu, DDS,MS

  West China Dental Institute of Chengdu

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2024
• First Posted: March 8, 2024
• Study Start: June 1, 2023
• Primary Completion: July 2, 2023
• Study Completion: July 2, 2023
• Last Updated: March 8, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)