A Clinical Study to Evaluate Experimental Children's Toothpastes in an In-Situ Caries Model

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Primary Purpose

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Fluoride

Placebo

About this trial

This is an interventional treatment trial for Dental Caries

Eligibility Criteria

11 Years - 14 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Healthy males and females aged 11 to 14 inclusive who have an unstimulated salivary flow rate of at least 0.2 mL/minute and a stimulated salivary flow rate of at least 0.8 mL/minute (Screening Visit 1).

Exclusion Criteria:

-

Sites / Locations

Indiana University School of Dentistry

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Arm Label

Fluoride free toothpaste

1426ppm Fluoride Toothpaste

1000 ppm Fluoride Toothpaste

500 ppm Toothpaste

Arm Description

toothpaste with no fluoride

Experimental toothpaste containing 1426 ppm Fluoride

Experimental toothpaste containing 1000 ppm Fluoride

Experimental toothpaste containing 500 ppm Fluoride

Outcomes

Primary Outcome Measures

Percentage Surface Microhardness Recovery of Test Dentifrices Relative to Placebo Dentifrice

Surface microhardness recovery (SMHR) test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMHR 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 rehardening of enamel surface. Percent SMHR was calculated from indentation values of enamel specimens at baseline (B), after in-situ hardening (R) and after first demineralization challenge (D1) using formula: [(D1-R)/ (D1-B)]*100.

Secondary Outcome Measures

%SMHR of Enamel Specimens Exposed to Test Treatments

Surface microhardness recovery (SMHR) test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMHR 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 rehardening of enamel surface. Percent SMHR was calculated from indentation values of enamel specimens at baseline (B), after in-situ hardening (R) and after first demineralization challenge (D1) using formula: [(D1-R)/ (D1-B)]*100.

Percent Net Acid Resistance (%NAR) of Enamel Specimens

Changes in mineral content of enamel specimens exposed to dietary erosive challenge were determined by measuring the length of the indentations. Decrease in the indentation length compared to the baseline indicates hardening of enamel surface. Enamel specimens were exposed to second erosion challenge to determine NAR which compared the indentations values of sound enamel specimens at baseline (B), first demineralization challenge (D1) and second demineralization challenge (D2). Percent NAR was calculated by formula: [(D1-D2)/ (D1-B)]*100.

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 amount of F divided by volume of the enamel cores and expressed as micrograms (μg)* F/centimeters(cm)^2. Difference between treatments was calculated with respect to F uptake by enamel.

Full Information

NCT ID

NCT01607411

First Posted

February 16, 2012

Last Updated

August 7, 2014

Sponsor

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT01607411

Brief Title

A Clinical Study to Evaluate Experimental Children's Toothpastes in an In-Situ Caries Model

Official Title

A Clinical Study to Evaluate Experimental Children's Toothpastes in an In-Situ Caries Model

Study Type

Interventional

2. Study Status

Record Verification Date

July 2014

Overall Recruitment Status

Completed

Study Start Date

February 2012 (undefined)

Primary Completion Date

May 2012 (Actual)

Study Completion Date

May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GlaxoSmithKline

4. Oversight

Data Monitoring Committee

No

5. Study Description

Brief Summary

An in situ model will be used to evaluate and compare enamel remineralization of human enamel specimens after single use of experimental children's toothpastes.

6. Conditions and Keywords

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

Dental Caries

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Crossover Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

55 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Fluoride free toothpaste

Arm Type

Placebo Comparator

Arm Description

toothpaste with no fluoride

Arm Title

1426ppm Fluoride Toothpaste

Arm Type

Experimental

Arm Description

Experimental toothpaste containing 1426 ppm Fluoride

Arm Title

1000 ppm Fluoride Toothpaste

Arm Type

Experimental

Arm Description

Experimental toothpaste containing 1000 ppm Fluoride

Arm Title

500 ppm Toothpaste

Arm Type

Experimental

Arm Description

Experimental toothpaste containing 500 ppm Fluoride

Intervention Type

Drug

Intervention Name(s)

Fluoride

Intervention Description

Fluoride Toothpaste

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Fluoride free toothpaste

Primary Outcome Measure Information:

Title

Percentage Surface Microhardness Recovery of Test Dentifrices Relative to Placebo Dentifrice

Description

Surface microhardness recovery (SMHR) test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMHR 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 rehardening of enamel surface. Percent SMHR was calculated from indentation values of enamel specimens at baseline (B), after in-situ hardening (R) and after first demineralization challenge (D1) using formula: [(D1-R)/ (D1-B)]*100.

Time Frame

Baseline to 4 hours

Secondary Outcome Measure Information:

Title

%SMHR of Enamel Specimens Exposed to Test Treatments

Description

Surface microhardness recovery (SMHR) test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMHR 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 rehardening of enamel surface. Percent SMHR was calculated from indentation values of enamel specimens at baseline (B), after in-situ hardening (R) and after first demineralization challenge (D1) using formula: [(D1-R)/ (D1-B)]*100.

Time Frame

Baseline to 4 hours

Title

Percent Net Acid Resistance (%NAR) of Enamel Specimens

Description

Changes in mineral content of enamel specimens exposed to dietary erosive challenge were determined by measuring the length of the indentations. Decrease in the indentation length compared to the baseline indicates hardening of enamel surface. Enamel specimens were exposed to second erosion challenge to determine NAR which compared the indentations values of sound enamel specimens at baseline (B), first demineralization challenge (D1) and second demineralization challenge (D2). Percent NAR was calculated by formula: [(D1-D2)/ (D1-B)]*100.

Time Frame

Baseline to 4 hours

Title

Enamel Fluoride Uptake

Description

Enamel fluoride uptake was determined using the microdrill enamel biopsy technique. The amount of fluoride uptake by enamel was calculated based on amount of F divided by volume of the enamel cores and expressed as micrograms (μg)* F/centimeters(cm)^2. Difference between treatments was calculated with respect to F uptake by enamel.

Time Frame

Baseline to 4 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

11 Years

Maximum Age & Unit of Time

14 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Healthy males and females aged 11 to 14 inclusive who have an unstimulated salivary flow rate of at least 0.2 mL/minute and a stimulated salivary flow rate of at least 0.8 mL/minute (Screening Visit 1). Exclusion Criteria: -

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

GSK Clinical Trials

Organizational Affiliation

GlaxoSmithKline

Official's Role

Study Director

Facility Information:

Facility Name

Indiana University School of Dentistry

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46202

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

24283282

Citation

Newby EE, Martinez-Mier EA, Hara A, Lippert F, Kelly SA, Fleming N, Butler A, Bosma ML, Zero DT. A randomised clinical study to evaluate experimental children's toothpastes in an in-situ palatal caries model in children aged 11-14 years. Int Dent J. 2013 Dec;63 Suppl 2(Suppl 2):31-8. doi: 10.1111/idj.12073.

Results Reference

result

Dental Caries

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial