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

Colgate-Palmolive

Status and phase: Not yet enrolling; Phase 3

Conditions: Oral Malodor

Treatments: Drug: Colgate Cavity Protection Toothpaste; Drug: Max Fresh Toothpaste

Study type: Interventional

Funder types: Industry

Identifiers

NCT07398378

CRO-2026-02-OMO-MFX-YPZ

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups

Test 1

Experimental group

Description:

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.

Treatment:

Drug: Max Fresh Toothpaste

Control toothpaste

Active Comparator group

Description:

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.

Treatment:

Drug: Colgate Cavity Protection Toothpaste