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Not yet recruiting Phase 3 NCT07398378

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

Phase 3 – large-scale trial before approval
Conditions: Oral Malodor

Sponsor: Colgate Palmolive

trial.available_in: БГ
Overview
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.
Who can participate
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).
Interventions
Max Fresh Toothpaste
DRUG
Colgate Cavity Protection Toothpaste
DRUG
Locations

Location information is not available.

Technical details
Status
Not yet recruiting
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
70 Years
Healthy volunteers
No
Start date
01.04.2026
Completion date
01.06.2026
Registry ID
NCT07398378
Source
clinicaltrials.gov
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