Evaluation of Oral Hygiene Products in an In Situ Caries Model

Dental Caries Clinical Trial

Official title:

Clinical Evaluation of Oral Hygiene Products in an In Situ Caries Model

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02399163
• Other study ID #: 203160
• Status: Completed
• Phase: N/A
• First received: March 23, 2015
• Last updated: August 24, 2015
• Start date: April 2015
• Est. completion date: August 2015

Study information

• Verified date: August 2015
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: August 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dental Caries

Intervention

Drug:
• Fluoride free toothpaste
Brushing with fluoride free toothpaste
• Fluoride toothpaste
Brushing with fluoride containing toothpaste
• Fluoride mouthwash
Fluoride mouth wash to be followed after brushing with fluoride free toothpaste in "Placebo dentifrice/Fluoride rinse" arm and in "Fluoride dentifrice/Fluoride rinse" arm

Locations

Country	Name	City	State
United States	GSK Investigational Site	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Enamel Remineralization	The Surface MicroHardness (SMH) laboratory test will be performed ex-vivo on the enamel specimens and will be used to assess changes in the mineral status of partially demineralized enamel specimens. SMH will be measured at baseline prior to demineralisation, post in vitro demineralisation and after 14 days of intral-oral exposure.	Baseline to 14 days	No
Secondary	Enamel Fluoride Uptake	The microdrill enamel biopsy technique will be used to analyze the fluoride content (uptake) of partially demineralized enamel post 14 days of treatment.	Baseline to 14 days	No
Secondary	Saliva fluoride concentration	Fluoride concentration in saliva will be measured after collecting saliva samples at the following time points: - at day 1 baseline prior to supervised treatment. - at day 1 post supervised treatment at site. - at day 14 post treatment use at home. The amount of fluoride in the samples will be calculated based on the amount of fluoride divided by the volume by the volume of the sample and expressed as µg/mL of sample.	Baseline to 14 days	No