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

NCT07398378 — Phase 3, Completed, 80 participants, Colgate Palmolive

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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

RegistryNCT07398378
StatusCompleted
PhasePhase 3
Study typeInterventional; randomized, parallel, masking: quadruple, treatment
Enrollment80 (Actual)
SponsorColgate Palmolive (Industry)
ConditionsOral Malodor
InterventionsMax Fresh Toothpaste, Colgate Cavity Protection Toothpaste (Drug)
Datesstart 2026-06-12, primary completion 2026-07-05, completion 2026-07-05, first posted 2026-02-09, last updated 2026-10-20
Locations1 site in China

Related Papers Related Patents Related Grants Related Experts
All trials for Oral Malodor All trials of Max Fresh Toothpaste All trials of Colgate Cavity Protection Toothpaste

-Summary

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.

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+Arms and interventions

ArmTypeInterventionsDescription
Test 1ExperimentalDrug: Max Fresh ToothpasteSubjects will brush their teeth for two (2) minutes each time, twice daily (morning and evening), using the assigned study toothpaste according to the manufacturer's instructions for three (3) weeks.
Control toothpasteActive comparatorDrug: Colgate Cavity Protection ToothpasteSubjects will brush their teeth for two (2) minutes each time, twice daily (morning and evening), using the assigned study toothpaste according to the manufacturer's instructions for three (3) weeks.
  • Max Fresh Toothpaste (Drug): 0.5% zinc citrate
  • Colgate Cavity Protection Toothpaste (Drug): sodium fluoride

+Outcome measures

Primary outcomes

  • Organoleptic Oral Malodor Evaluations [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

+Eligibility

Sex: All, ages: 18 Years to 70 Years, accepts healthy volunteers

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).

+Locations (1)

FacilityCityCountryStatus
West China Dental Institute of ChengduChengdu, SichuanChina