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Completed
NCT07398378
Clinical Investigation of Oral Malodor for Max Fresh Toothpaste Containing Zinc Citrate Versus a Commercially Available Regular Fluoride Toothpaste
Conditions: Oral Malodor
Sex: All
Ages: 18 Years – 70 Years
Healthy volunteers: Yes
Phase: PHASE3
Enrollment: 80
Sponsor: Colgate Palmolive
Location: West China Dental Institute of Chengdu Chengdu Sichuan
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.
Eligibility Criteria
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).
Source: ClinicalTrials.gov (NCT07398378). StuddyBuddy aggregates publicly available trial information.