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
Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
Accepted
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).
Primary outcome measure(s)
Organoleptic Oral Malodor Evaluations — baseline, 3 weeks 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
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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