Plaque, Dental
Conditions
Keywords
saliva
Brief summary
Proof of concept clinical study to measure plaque metabolism and the prebiotic efficacy of arginine-containing toothpaste.
Interventions
1000ppm fluoride
DRUGTOM's Superior Sensitivity Relief Toothpaste
fluoride free
Sponsors
Colgate Palmolive
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Signed Informed Consent Form. * Male and female subjects aged 18-70 years, inclusive. * Availability for the nine-week duration of the clinical research study. * Good general health based on the opinion of the study investigator * Good general health
Exclusion criteria
* Moderate and/or advanced periodontal disease, rampant caries, or any condition that the dental examiner considers exclusionary from the study. * Five or more carious lesions requiring immediate care. * Concurrent participation in any other oral care clinical study or test panel. * Self-reported pregnant or lactating women. * Dental prophylaxis received in the past four weeks prior to baseline examinations * History of tobacco use-smoking, vaping and chewing tobacco * Presence of orthodontic bands, presence of partial removable dentures * Tumor(s) of the soft or hard tissues of the oral cavity * Use of antibiotics or stain inducing medications any time during the two month prior to entry into the study * Use of oral care products containing antimicrobials (Zn, Sn, CPC, triclosan, alcohol containing mouthwash, etc
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plaque collection | baseline, week 3, week 4, week 6, week 7, week 8, week 9 | Fasting plaque will be collected before and after a sucrose rinse for lactic acid analysis and ammonia production.The plaque pH of collected samples will also be measured to provide trend data. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Saliva collection | week 5 and week 9 | Differences in the arginine concentration in saliva pre- and post-brushing with treatment. Differences in microbiome composition and activity |
Countries
United States
Outcome results
None listed