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Experimental Dentifrice Remineralization/Fluoride Uptake in an in Situ Model

Primary Purpose

Dental Erosion

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

NaF/ KNO3/isopentane Dentifrice

NaF/KNO3 Dentifrice

NaF Dentifrice

Placebo Dentifrice

About this trial

This is an interventional treatment trial for Dental Erosion focused on measuring enamel fluoride uptake, erosion, enamel remineralization

Eligibility Criteria

18 Years - 78 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Age: Aged between 18 and 78
Fluoride: Currently living in the Indianapolis area which has a fluoridated water supply (1 ppm F) and not taking fluoride supplements for medical reasons
Dentures: Currently wearing a removable mandibular partial denture with sufficient room in the posterior buccal flange area to accommodate two enamel specimens (required dimensions 12 x 7 mm). Willing and capable of wearing their removable partial dentures 24 hours per day during the experimental periods
Dental health:Have no current active caries or periodontal disease that may compromise the study or the health of the participants and all restorations in a good state of repair
Salivary flow:Have a salivary flow rate in the range of normal values (unstimulated whole saliva flow rate ≥ 0.2 mL/min; gum base stimulated whole saliva flow rate ≥ 0.8 mL/min
Compliance: Understands and is willing, able and likely to comply with all study procedures and restrictions
Consent:Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form
General Health: Good general health with (in the opinion of the investigator) no clinically significant and/or relevant abnormalities of medical history or oral examination that could interfere with participant safety during the study period

Exclusion Criteria:

Antibiotics:Currently taking antibiotics or have taken antibiotics in the two weeks prior to the screening visit
Allergy/Intolerance:Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients
Pregnancy:Women who are known to be pregnant or who are intending to become pregnant over the duration of the study.
Breast-feeding:Women who are breast-feeding.
Clinical Study/Experimental Medication: Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit
Personnel:An employee of the sponsor or the study site who is directly involved in the study

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Sodium fluoride/potassium nitrate/Isopentane dentifrice

NaF/KNO3 Dentifrice

NaF Dentifrice

Placebo Dentifrice

Arm Description

Participants to brush their teeth for one timed minute twice daily with a gel to foam dentifrice containing active ingredients: 1450 ppm F as sodium fluoride (NaF) and 5% potassium nitrate (KNO3) and isopentane as an excipient ingredient.

Participants to brush their teeth for one timed minute twice daily with a gel to foam dentifrice, containing as active ingredients: 1450 ppm NaF and 5% KNO3 but no isopentane.

Participants to brush their teeth for one timed minute twice daily with a dentifrice containing 1450 ppm F as NaF.

Participants to brush their teeth for one timed minute twice daily with a fluoride free dentifrice (0 ppm F).

Outcomes

Primary Outcome Measures

Percentage Surface Micro-hardness Recovery (SMHR) of Enamel Specimens

SMH test was used to assess mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMH was 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. Percent SMHR was calculated from indentation values of enamel specimens at baseline (B), after intra-oral exposure (R) and after in-vitro demineralization (D) using formula: [(D-R)/ (D-B)]*100.

Secondary Outcome Measures

Adjusted Mean Change From Baseline in Enamel Fluoride Uptake

Enamel fluoride uptake was determined using the microdrill enamel biopsy technique. The amount of fluoride uptake by enamel was calculated based on the amount of fluoride (F) divided by the area of the enamel cores and expressed as ug*F/cm^3. The difference between treatments was calculated with respect to fluoride uptake by enamel.

Full Information

NCT ID

NCT00752089

First Posted

September 11, 2008

Last Updated

October 17, 2016

Sponsor

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT00752089

Brief Title

Experimental Dentifrice Remineralization/Fluoride Uptake in an in Situ Model

Official Title

Exploratory Evaluation of an Experimental Fluoride Dentifrice Formulation Using an in Situ Remineralization/Fluoride Uptake Model

Study Type

Interventional

2. Study Status

Record Verification Date

May 2016

Overall Recruitment Status

Completed

Study Start Date

September 2007 (undefined)

Primary Completion Date

January 2008 (Actual)

Study Completion Date

January 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GlaxoSmithKline

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to determine whether an experimental fluoridated dentifrice is effective in the treatment of dental caries

Detailed Description

Topical fluorides have been proven to be clinically effective in the prevention of dental caries. It is generally agreed that anti-caries effect of fluoride (F) is mainly by decreasing the rate of enamel demineralization and enhancing the rate of enamel remineralization. An in-situ Surface Micro-hardness (SMH) test is widely used to evaluate enamel demineralization and remineralization during the caries process. Determination of fluoride uptake in-situ also provides better estimation of true fluoride bioavailability of fluoride dentifrice products. In this study, an in-situ remineralization fluoride uptake model will be used to compare the efficacy of experimental dentifrice with a marketed dentifrice and placebo dentifrice. Participants wore partial dentures containing two partially demineralized enamel specimens for two weeks- 24 hours per day, except when brushing (twice daily) with test dentifrice. Following each treatment period, the enamel specimens were analyzed for SMH recovery and fluoride uptake through microdrill enamel biopsy technique.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dental Erosion

Keywords

enamel fluoride uptake, erosion, enamel remineralization

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

Participant

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Sodium fluoride/potassium nitrate/Isopentane dentifrice

Arm Type

Experimental

Arm Description

Arm Title

NaF/KNO3 Dentifrice

Arm Type

Experimental

Arm Description

Participants to brush their teeth for one timed minute twice daily with a gel to foam dentifrice, containing as active ingredients: 1450 ppm NaF and 5% KNO3 but no isopentane.

Arm Title

NaF Dentifrice

Arm Type

Active Comparator

Arm Description

Participants to brush their teeth for one timed minute twice daily with a dentifrice containing 1450 ppm F as NaF.

Arm Title

Placebo Dentifrice

Arm Type

Placebo Comparator

Arm Description

Participants to brush their teeth for one timed minute twice daily with a fluoride free dentifrice (0 ppm F).

Intervention Type

Drug

Intervention Name(s)

NaF/ KNO3/isopentane Dentifrice

Intervention Description

Experimental toothpaste

Intervention Type

Drug

Intervention Name(s)

NaF/KNO3 Dentifrice

Intervention Description

Experimental toothpaste

Intervention Type

Drug

Intervention Name(s)

NaF Dentifrice

Intervention Description

Active comparator

Intervention Type

Other

Intervention Name(s)

Placebo Dentifrice

Intervention Description

Placebo comparator

Primary Outcome Measure Information:

Title

Percentage Surface Micro-hardness Recovery (SMHR) of Enamel Specimens

Description

Time Frame

Baseline to 14 days

Secondary Outcome Measure Information:

Title

Adjusted Mean Change From Baseline in Enamel Fluoride Uptake

Description

Time Frame

Baseline to 14 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

78 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age: Aged between 18 and 78 Fluoride: Currently living in the Indianapolis area which has a fluoridated water supply (1 ppm F) and not taking fluoride supplements for medical reasons Dentures: Currently wearing a removable mandibular partial denture with sufficient room in the posterior buccal flange area to accommodate two enamel specimens (required dimensions 12 x 7 mm). Willing and capable of wearing their removable partial dentures 24 hours per day during the experimental periods Dental health:Have no current active caries or periodontal disease that may compromise the study or the health of the participants and all restorations in a good state of repair Salivary flow:Have a salivary flow rate in the range of normal values (unstimulated whole saliva flow rate ≥ 0.2 mL/min; gum base stimulated whole saliva flow rate ≥ 0.8 mL/min Compliance: Understands and is willing, able and likely to comply with all study procedures and restrictions Consent:Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form General Health: Good general health with (in the opinion of the investigator) no clinically significant and/or relevant abnormalities of medical history or oral examination that could interfere with participant safety during the study period Exclusion Criteria: Antibiotics:Currently taking antibiotics or have taken antibiotics in the two weeks prior to the screening visit Allergy/Intolerance:Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients Pregnancy:Women who are known to be pregnant or who are intending to become pregnant over the duration of the study. Breast-feeding:Women who are breast-feeding. Clinical Study/Experimental Medication: Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit Personnel:An employee of the sponsor or the study site who is directly involved in the study

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

GSK Clinical Trials

Organizational Affiliation

GlaxoSmithKline

Official's Role

Study Director

12. IPD Sharing Statement

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Experimental Dentifrice Remineralization/Fluoride Uptake in an in Situ Model

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