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Completed

NCT Number: NCT06300905

Clinical Study on Malodor

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.

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Key information

Conditions

Oral Malodor

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

West China Dental Institute of Chengdu

Chengdu, Sichuan, 610041, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

test product

Drug

toothpaste containing 0.45% stannous fluoride

Control product

Drug

toothpaste containing 0.76% sodium monofluorophosphate

Primary outcomes

  1. Organoleptic Oral Malodor Evaluations

    Time frame: Oral malodor evaluations at baseline & 3 weeks

    The measured levels of oral malodor will be expressed in organoleptic scales (1-9)

Sponsors and collaborators

Lead sponsor

Colgate Palmolive

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Mar 8, 2024
Registry last updated
Mar 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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