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
| Registry | NCT07398378 |
|---|---|
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional; randomized, parallel, masking: quadruple, treatment |
| Enrollment | 80 (Actual) |
| Sponsor | Colgate Palmolive (Industry) |
| Conditions | Oral Malodor |
| Interventions | Max Fresh Toothpaste, Colgate Cavity Protection Toothpaste (Drug) |
| Dates | start 2026-06-12, primary completion 2026-07-05, completion 2026-07-05, first posted 2026-02-09, last updated 2026-10-20 |
| Locations | 1 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
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Test 1 | Experimental | Drug: Max Fresh Toothpaste | Subjects 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 toothpaste | Active comparator | Drug: Colgate Cavity Protection Toothpaste | Subjects 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. |
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).
| Facility | City | Country | Status |
|---|---|---|---|
| West China Dental Institute of Chengdu | Chengdu, Sichuan | China |