Evaluation of Oral Hygiene Products in an In Situ Caries Model
| Status: | Completed |
|---|---|
| Conditions: | Other Indications, Dental |
| Therapuetic Areas: | Dental / Maxillofacial Surgery, Other |
| Healthy: | No |
| Age Range: | 18 - 85 |
| Updated: | 4/21/2016 |
| Start Date: | April 2015 |
| End Date: | August 2015 |
Clinical Evaluation of Oral Hygiene Products in an In Situ Caries Model
The study will evaluate and compare the potential anti-caries efficacy of a test regimen:
placebo (fluoride free) toothpaste (twice daily use) plus fluoride mouthwash (once daily
use), in comparison with brushing with a placebo toothpaste alone (twice daily use), to
remineralize previously demineralized enamel specimens, as measured by Surface MicroHardness
Recovery (%SMHR).
This will be a single center, randomized, laboratory analyst blinded, placebo, four
treatment, cross-over study in healthy participants. Participants will be assessed at
baseline and at the beginning and end of each treatment visit to monitor clinical efficacy
and safety.
placebo (fluoride free) toothpaste (twice daily use) plus fluoride mouthwash (once daily
use), in comparison with brushing with a placebo toothpaste alone (twice daily use), to
remineralize previously demineralized enamel specimens, as measured by Surface MicroHardness
Recovery (%SMHR).
This will be a single center, randomized, laboratory analyst blinded, placebo, four
treatment, cross-over study in healthy participants. Participants will be assessed at
baseline and at the beginning and end of each treatment visit to monitor clinical efficacy
and safety.
Inclusion Criteria:
1. Aged between 18 and 85 years inclusive
2. Understands and is willing, able and likely to comply with all study procedures and
restrictions
3. Good general and mental health with, in the opinion of the investigator or medically
qualified designee:
- No clinically significant and relevant abnormalities in medical history or upon
oral examination.
- Absence of any condition that could affect the participant's safety or
well-being or their ability to understand and follow study procedures and
requirements
4. Currently living in the Indianapolis, Indiana area and has not had a professional
fluoride treatment within 14 days of the first treatment visit
5. Currently wearing a removable mandibular partial denture with sufficient room in one
posterior buccal flange areas to accommodate two enamel specimens
6. Willing to have their denture modified to accommodate enamel test specimens and
willing and capable of wearing their removable mandibular partial dentures 24 hours
per day during the experimental periods
7. Have a salivary flow rate in the range of normal values (un-stimulated whole saliva
flow rate ≥ 0.2 milliliter (mL)/minute; gum base stimulated whole saliva flow rate ≥
0.8 mL/minute).
Exclusion Criteria:
1. Pregnant or breast feeding women
2. Known or suspected intolerance or hypersensitivity to the study materials (or closely
related compounds) or any of their stated ingredients
3. Currently taking antibiotics or have taken antibiotics in the two weeks prior to the
screening visit.
4. Taking or have taken a bisphosphonate drug for treatment of osteoporosis.
5. Participation in another GSKCH investigational dental product study within seven days
of first study treatment.
6. Previous participation in this study.
7. Recent history (within the last year) of alcohol or other substance abuse.
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