Evaluation of Oral Hygiene Products in an In Situ Caries Model
Completed · Not applicable · Has a placebo group
Conditions studied: Dental Caries
In brief
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.
Key facts
- Study ID
- NCT02399163
- Run by
- GlaxoSmithKline
- People needed
- 80
- Starts
- 2015-04-01
- Expected to finish
- 2015-08-01
- Last updated by the study team
- 2016-05-12
Who can join
Age: 18 and older, up to 85. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Aged between 18 and 85 years inclusive
- Understands and is willing, able and likely to comply with all study procedures and restrictions
- 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
- Currently living in the Indianapolis, Indiana area and has not had a professional fluoride treatment within 14 days of the first treatment visit
- Currently wearing a removable mandibular partial denture with sufficient room in one posterior buccal flange areas to accommodate two enamel specimens
- 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
- 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).
You may not qualify if…
- Pregnant or breast feeding women
- Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients
- Currently taking antibiotics or have taken antibiotics in the two weeks prior to the screening visit.
- Taking or have taken a bisphosphonate drug for treatment of osteoporosis.
- Participation in another GSKCH investigational dental product study within seven days of first study treatment.
- Previous participation in this study.
- Recent history (within the last year) of alcohol or other substance abuse.
Where it is running
- GSK Investigational Site — Indianapolis, Indiana, United States
Full record on ClinicalTrials.gov
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