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 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 |
Contacts
CONTACTDeyu Hu, DDS, MS
CONTACTZhi Zhou, DDS, PhD
Outcome results
None listed