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NCT Number: NCT07398378

Clinical Investigation of Oral Malodor for Max Fresh Toothpaste Containing Zinc Citrate Versus a Commercially Available Regular Fluoride Toothpaste

The objective of this three-week clinical research study is to evaluate oral malodor for a toothpaste containing zinc citrate as compared to a commercially available regular fluoride toothpaste using the organoleptic method.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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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

  • Adults aged 18-70 years, inclusive.
  • Availability for the full three-week duration of the study.
  • Good general health.
  • Initial mean oral malodor (organoleptic) score ≥ 6.0 and ≤ 8.4.
  • Signed informed consent form.

Exclusion criteria

  • Presence of orthodontic bands.
  • Tumors of the soft or hard tissues of the oral cavity.
  • Advanced periodontal disease (e.g., purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone).
  • Five (5) or more carious lesions requiring immediate restorative treatment.
  • Use of antibiotics within one (1) month prior to study entry.
  • Participation in any other clinical study or test panel within one (1) month prior to study entry.
  • Dental prophylaxis within two (2) weeks prior to the initial examination.
  • History of allergies to oral care/personal care products or their ingredients.
  • Use of prescription medications that might interfere with study outcomes.
  • Medical condition that prevents fasting (no food or drink) for up to four (4) hours.
  • History of drug and/or alcohol abuse.
  • Pregnant or lactating (self-reported).

Treatment and study plan

Max Fresh Toothpaste

Drug

0.5% zinc citrate

Colgate Cavity Protection Toothpaste

Drug

sodium fluoride

Primary outcomes

  1. Organoleptic Oral Malodor Evaluations

    Time frame: baseline, 3 weeks

    Baseline evaluations will be conducted in the morning. On the morning of the evaluation, subjects must refrain for at least six (6) hours from all oral hygiene (brushing, rinsing, and flossing) and from eating and drinking prior to the scheduled visit.

    At baseline, the mean of the scores from the four judges will constitute each subject's baseline oral malodor score. Subjects with a baseline mean score ≥ 6.0 and ≤ 8.4 will be enrolled

Sponsors and collaborators

Lead sponsor

Colgate Palmolive

Industry

Registry information

Official study title

Clinical Investigation of Oral Malodor for Max Fresh Toothpaste Containing Zinc Citrate Versus a Commercially Available Regular Fluoride Toothpaste Using the Organoleptic Method: a Three-week Study in China

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 9, 2026
Registry last updated
Jun 17, 2026

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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