Last updated: 11/07/2018 12:33:58
Evaluation of Oral Hygiene Products in an In Situ Caries Model
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: Clinical Evaluation of Oral Hygiene Products in an In Situ Caries Model
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Single (Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Percentage Surface Microhardness Recovery (%SMHR) of Placebo dentifrice/Fluoride Rinse compared to Placebo Dentifrice/No Rinse
Timeframe: Baseline to 14 days
Secondary outcomes:
Percentage Surface Microhardness Recovery (SMHR) of Placebo dentifrice/Fluoride Rinse, Placebo dentifrice/No Rinse, Fluoride dentifrice/No rinse and Fluoride dentifrice/Fluoride rinse
Timeframe: Baseline to 14 days
Enamel Fluoride Uptake
Timeframe: Baseline to 14 days
Change in Saliva fluoride concentration from baseline (pre-treatment) to Day 14
Timeframe: Baseline to Day14
Change in Saliva fluoride concentration from baseline (post-treatment) to Day 14
Timeframe: Baseline up to Day 14
Interventions:
Drug: Fluoride free toothpaste
Drug: Fluoride toothpaste
Drug: Fluoride mouthwash
Enrollment:
80
Observational study model:
Not applicable
Primary completion date:
2015-05-08
Time perspective:
Not applicable
Clinical publications:
https://doi.org/10.1016/j.jdent.2017.12.015
Medical condition
dental caries
Product
sodium fluoride
Collaborators
Not applicable
Study date(s)
April 2015 to August 2015
Type
Interventional
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
18 - 85 years
Accepts healthy volunteers
Yes
- 1. Aged between 18 and 85 years inclusive
- 2. Understands and is willing, able and likely to comply with all study procedures and restrictions
- 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
Inclusion and exclusion criteria
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.
Trial location(s)
Location
GSK Investigational Site
Indianapolis, Indiana, United States, 46202
Status
Study Complete
Study documents
Statistical analysis plan
Available language(s): English
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
Protocol
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2015-05-08
Actual study completion date
2015-05-08
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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