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

NCT07398378 | Not Yet Recruiting Phase 3 FDA Drug

• 1 other identifier: CRO-2026-02-OMO-MFX-YPZ
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Oral Malodor

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Test 1

EXPERIMENTAL

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

Control toothpaste

ACTIVE COMPARATOR

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

Interventions

Max Fresh Toothpaste DRUG

0.5% zinc citrate

Test 1

Colgate Cavity Protection Toothpaste DRUG

sodium fluoride

Control toothpaste

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Colgate Palmolive: lead

Central Study Contacts

Deyu Hu, DDS, MS

CONTACT

86-1390-803-4990; hudeyu@wcdicd.cn

Zhi Zhou, DDS, PhD

CONTACT

86-1306-238-1906; 500119@hospital.cqmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2026
• First Posted: February 9, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share