Clinical trial NCT02399163: Evaluation of Oral Hygiene Products in an In Situ Caries Model
Official title: Clinical Evaluation of Oral Hygiene Products in an In Situ Caries Model
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Caries
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2015-03-26
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Percentage Surface Microhardness Recovery (%SMHR) of Placebo Dentifrice/Fluoride Rinse Compared to Placebo Dentifrice/No Rinse
timeFrame: Baseline to 14 days
Secondary outcomes:
measure: 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
measure: Enamel Fluoride Uptake
timeFrame: Baseline to 14 days
measure: Change in Saliva Fluoride Concentration From Baseline (Pre-treatment) to Day 14
timeFrame: Baseline to Day14
measure: Change in Saliva Fluoride Concentration From Baseline (Post-treatment) to Day 14
timeFrame: Baseline up to Day 14
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: GSK Investigational Site
state: Indiana
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: