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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Oral Malodor
• Intervention / Treatment: Drug: Max Fresh Toothpaste; Drug: Colgate Cavity Protection Toothpaste

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Deyu Hu, DDS, MS; Phone Number: 86-1390-803-4990; Email: hudeyu@wcdicd.cn
• Study Contact Backup: Name: Zhi Zhou, DDS, PhD; Phone Number: 86-1306-238-1906; Email: 500119@hospital.cqmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test 1; 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.	Drug: Max Fresh Toothpaste; 0.5% zinc citrate
Active Comparator: Control 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.	Drug: Colgate Cavity Protection Toothpaste; sodium fluoride

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Organoleptic Oral Malodor Evaluations	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	baseline, 3 weeks

Collaborators and Investigators

• Sponsor: Colgate Palmolive

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: February 2, 2026
• First Submitted That Met QC Criteria: February 2, 2026
• First Posted (Actual): February 9, 2026

Study Record Updates

• Last Update Posted (Actual): April 17, 2026
• Last Update Submitted That Met QC Criteria: April 14, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: CRO-2026-02-OMO-MFX-YPZ

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes