Evaluation of Oral Hygiene Products in an In Situ Caries Model

NCT ID: NCT02399163

Last Updated: 2016-05-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2015-08-31

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.

Conditions

Dental Caries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Placebo dentifrice/Fluoride rinse

Twice daily brushing with a non-fluoride (placebo) toothpaste followed by once daily rinsing (post night time brushing) with a fluoride mouthwash containing 220 ppm of fluoride as sodium fluoride

Group Type: EXPERIMENTAL

Fluoride free toothpaste

Intervention Type: DRUG

Brushing with fluoride free toothpaste

Fluoride mouthwash

Intervention Type: DRUG

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

Placebo dentifrice/No rinse

Twice daily brushing with a non-fluoride (placebo) toothpaste

Group Type: PLACEBO_COMPARATOR

Fluoride free toothpaste

Intervention Type: DRUG

Brushing with fluoride free toothpaste

Fluoride dentifrice/No rinse

Twice daily brushing with a fluoride toothpaste containing 1150 ppm of fluoride as sodium fluoride

Group Type: ACTIVE_COMPARATOR

Fluoride toothpaste

Intervention Type: DRUG

Brushing with fluoride containing toothpaste

Fluoride dentifrice/Fluoride rinse

Twice daily brushing with a fluoride toothpaste containing 1150 ppm of fluoride as sodium fluoride, followed by once daily rinsing (post night time brushing) with a fluoride mouthwash containing 220 ppm of fluoride as sodium fluoride.

Group Type: EXPERIMENTAL

Fluoride toothpaste

Intervention Type: DRUG

Brushing with fluoride containing toothpaste

Fluoride mouthwash

Intervention Type: DRUG

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

Interventions

Fluoride free toothpaste

Brushing with fluoride free toothpaste

Intervention Type: DRUG

Fluoride toothpaste

Brushing with fluoride containing toothpaste

Intervention Type: DRUG

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Indianapolis, Indiana, United States

Countries

United States

Other Identifiers

203160

Identifier Type: -

Identifier Source: org_study_id