Oral Malodor
Conditions
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.
Interventions
DRUGMax Fresh Toothpaste
0.5% zinc citrate
sodium fluoride
Sponsors
Colgate Palmolive
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| organoleptic method | baseline, 3 weeks | assessed using the 1-9 organoleptic scale |
Contacts
CONTACTDeyu Hu, DDS, MS
CONTACTZhi Zhou, DDS, PhD
Outcome results
None listed