Evaluation of Oral Hygiene Products in an In Situ Caries Model

Not Applicable

Completed

• Conditions: Dental Caries
• Interventions: Drug: Fluoride free toothpaste; Drug: Fluoride toothpaste; Drug: Fluoride mouthwash

• Registration Number: NCT02399163
• Lead Sponsor: GlaxoSmithKline

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-03-23
• Study First Submitted QC: 2015-03-23
• Study First Posted: 2015-03-26
• Study Start: 2015-04
• Primary Completion: 2015-07
• Study Completion: 2015-08
• Status Verified: 2016-04
• Results First Submitted: 2016-04-04
• Results First Submitted QC: 2016-04-07
• Last Update Submitted: 2016-04-07
• Results First Posted: 2016-05-12
• Last Update Posted: 2016-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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).

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo dentifrice/Fluoride rinse	Fluoride free toothpaste	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
Fluoride dentifrice/No rinse	Fluoride toothpaste	Twice daily brushing with a fluoride toothpaste containing 1150 ppm of fluoride as sodium fluoride
Placebo dentifrice/Fluoride rinse	Fluoride mouthwash	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
Placebo dentifrice/No rinse	Fluoride free toothpaste	Twice daily brushing with a non-fluoride (placebo) toothpaste
Fluoride dentifrice/Fluoride rinse	Fluoride mouthwash	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.
Fluoride dentifrice/Fluoride rinse	Fluoride toothpaste	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.

Primary Outcome Measures

Name	Time	Method
Percentage Surface Microhardness Recovery (%SMHR) of Placebo Dentifrice/Fluoride Rinse Compared to Placebo Dentifrice/No Rinse	Baseline to 14 days	SMHR test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMHR was performed ex-vivo and determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents re-hardening of enamel surface. % SMH recovery was calculated from indentation length (micrometer \[μm\]) of sound enamel specimen at baseline(B), indentation length (μm) after in vitro demineralization(D1), indentation length (μm) after intra-oral exposure (R): \[D1-R/D1-B\]\*100.

Secondary Outcome Measures

Name	Time	Method
Percentage Surface Microhardness Recovery (SMHR) of Placebo Dentifrice/Fluoride Rinse, Placebo Dentifrice/No Rinse, Fluoride Dentifrice/No Rinse and Fluoride Dentifrice/Fluoride Rinse	Baseline to 14 days	SMHR test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMHR was performed ex-vivo and determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents rehardening of enamel surface. % SMH recovery was calculated from indentation length (micrometer \[μm\]) of sound enamel specimen at baseline(B), indentation length (μm) after in vitro demineralization(D1), indentation length (μm) after intra-oral exposure (R): \[D1-R/D1-B\]\*100.
Enamel Fluoride Uptake	Baseline to 14 days	The microdrill enamel biopsy technique was used to analyze the fluoride uptake by enamel. Each enamel specimen was mounted on the long axis of a drill attached to a microdrill and drilled to a depth of approximately 100 micrometer (μm) through the entire lesion (four cores per specimen). The enamel powder pooled from four drilling samples was then immediately analyzed for fluoride content using fluoride specific electrode and pH/ion meter. The amount of fluoride-uptake by enamel was calculated based on the amount of fluoride divided by the area of the enamel cores and expressed as microgram per square centimeter (μg/cm\^2).
Change in Saliva Fluoride Concentration From Baseline (Pre-treatment) to Day 14	Baseline to Day14	Fluoride concentration in saliva was 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. The amount of fluoride in the samples was calculated based on the amount of fluoride divided by the volume of the sample and expressed as μg/mL of sample.
Change in Saliva Fluoride Concentration From Baseline (Post-treatment) to Day 14	Baseline up to Day 14	Fluoride concentration in saliva was measured after collecting saliva samples at the following time points: - at Day 1 post supervised treatment at site. - at Day 14 post treatment. The amount of fluoride in the samples was calculated based on the amount of fluoride divided by the volume of the sample and expressed as μg/mL of sample.

Trial Locations

Locations (1)

GSK Investigational Site; 🇺🇸 Indianapolis, Indiana, United States