N/A
Completed N=62
Evaluation of Oral Hygiene Products in an In Situ Caries Model
Source: ClinicalTrials.gov NCT02399163 ↗Enrolled (actual)
62
Serious AEs
1.3%
Results posted
May 2016
Primary outcomePrimary: Percentage Surface Microhardness Recovery (%SMHR) of Placebo Dentifrice/Fluoride Rinse Compared to Placebo Dentifrice/No Rinse — 24.48; 8.09 % SMHR — p=<0.0001
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage Surface Microhardness Recovery (%SMHR) of Placebo Dentifrice/Fluoride Rinse Compared to Placebo Dentifrice/No Rinse |
24.48; 8.09 | <0.0001 sig |
| SECONDARY Percentage Surface Microhardness Recovery (SMHR) of Placebo Dentifrice/Fluoride Rinse, Placebo Dentifrice/No Rinse, Fluoride Dentifrice/No Rinse and Fluoride Dentifrice/Fluoride Rinse |
24.48; 8.09; 28.36; 30.01 | — |
| SECONDARY Enamel Fluoride Uptake |
7.22; 1.60; 8.01; 9.97 | — |
| SECONDARY Change in Saliva Fluoride Concentration From Baseline (Pre-treatment) to Day 14 |
0.06; -0.01; 0.00; 0.06 | — |
| SECONDARY Change in Saliva Fluoride Concentration From Baseline (Post-treatment) to Day 14 |
13.08; 0.05; 8.62; 13.81 | — |
Eligibility Criteria
Inclusion Criteria
- 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).
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT02399163). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.