Clinical Study on Malodor

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06300905

Enrollment

100

Registered

2024-03-08

Start date

2023-06-01

Completion date

2023-07-02

Last updated

2024-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oral Malodor

Keywords

Organoleptic method, oral malodor

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.

Interventions

DRUGtest product

toothpaste containing 0.45% stannous fluoride

DRUGControl product

toothpaste containing 0.76% sodium monofluorophosphate

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Yes

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)

Design outcomes

Primary

Measure	Time frame	Description
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)

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026