Back to resultsEvaluation of Efficacy of Experimental Gel to Foam Dentifrices in Dental Erosion
Primary Purpose
Dental Erosion, Acid Wear
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sodium Fluoride
Potassium nitrate
Sponsored by
About this trial
This is an interventional treatment trial for Dental Erosion
Eligibility Criteria
Inclusion Criteria:
- General and Oral Health: Good general health with (in the opinion of the investigator) no clinically OST and OHT examinations.
Oral Requirements:
- An intact maxillary dental arch suitable for the retention of the palatal appliance and an intact mandibular dental arch. Subjects may have fixed bridges replacing missing teeth.
- A gum base stimulated whole saliva flow rate ≥ 0.8 g/min and an unstimulated whole saliva flow rate ≥ 0.2 g/min.
- Contraception: Women of childbearing potential who are, in the opinion of the investigator, practicing a reliable method of contraception.
Exclusion Criteria:
Oral Health:
- Current active caries or periodontal disease that may compromise the study or the health of the subjects.
- Lesions of the oral cavity that could interfere with the study evaluations, including severe gingivitis, grossly carious lesions, periodontitis and other severe periodontal disease.
- Allergy/Intolerance: Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
Clinical Study/Experimental Medication:
- Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit
- Previous participation in this study
- Substance abuse: Recent history (within the last year) of alcohol or other substance abuse.
- Pregnancy: Women who are pregnant or who are intending to become pregnant over the duration of the study
- Breast-feeding: Women who are breast-feeding
Sites / Locations
- Indiana University School of Dentistry
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Active Comparator
Placebo Comparator
Arm Label
NaF/KNO3 toothpaste, Low RDA
NaF/KNO3 toothpaste, Medium RDA
NaF/KNO3 toothpaste
No fluoride/KNO3 toothpaste
Arm Description
Participants to brush with 1.5 g of low RDA gel to foam toothpaste containing 1450 ppm F - EU level as NaF. All study treatments contain 5% weight by weight (w/w) KNO3.
Participants to brush with 1.5 g of medium RDA gel to foam toothpaste containing 1450 ppm F - EU level as NaF. All study treatments contain 5% w/w KNO3.
Participants to brush with 1.5 g of NaF/KNO3 toothpaste containing 1450 ppm F - EU level as NaF. All study treatments contain 5% w/w KNO3.
Participants to brush with a fluoride free toothpaste (0 ppmF). All study treatments contain 5% w/w KNO3.
Outcomes
Primary Outcome Measures
Relative Erosion Resistance (RER) of Enamel Specimens Post 4 Hours of Treatment Exposure
Enamel specimens were exposed to dietary erosive challenge and set of five indentations within each specimen was measured. Decrease in the indentation length compared to the baseline indicates hardening of enamel surface. Enamel specimens were exposed to second erosion challenge to determine RER which compared the indentations values of enamel specimens at baseline (B), first erosive (E1) and second erosive challenge (E2). Percent RER was calculated by formula: [(E1-E2)/ (E1-B)]*100. Smaller the negative RER, better is treatment regimen in imparting resistance to enamel.
Surface Microhardness (SMH) Recovery of Enamel Specimens Post 4 Hours of Treatment Exposure
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 rehardening of enamel surface. Percent SMH recovery was calculated from indentation values of enamel specimens at baseline (B), after in-situ hardening (R) and after first erosive challenge (E1) using formula: [(E1- R)/ (E1-B)]*100. A higher percentage values indicate a better outcome.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01657903
Brief Title
Evaluation of Efficacy of Experimental Gel to Foam Dentifrices in Dental Erosion
Official Title
A Placebo Controlled Study to Evaluate the Effectiveness of Experimental Foaming Gel Toothpastes Using an In-situ Erosion Remineralization Model
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
February 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
The purpose of this study is to compare and evaluate the ability of two European Union (EU) regulated gel to foam toothpaste formulations versus a non-fluoride toothpaste using a modified in-situ model of dental erosion and remineralization. A positive control i.e fluoride containing toothpaste marketed in EU will also be compared to non-fluoride toothpaste.
Detailed Description
The aim of this study is to assess the remineralization effects of two EU gel to foam toothpaste formulations with 1450 parts per million (ppm) of fluoride as sodium fluoride (NaF) and 5% potassium nitrate (KNO3) versus a non-fluoride (0 ppm F)/KNO3 toothpaste as a negative control. The two experimental gel to foam toothpaste formulations differ in their relative dentine abrasivity (RDA) values which is an in-vitro measure of a toothpaste abrasivity to the dentinal tissues. A marketed toothpaste containing NaF and KNO3 will serve as a positive control.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Erosion, Acid Wear
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
56 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NaF/KNO3 toothpaste, Low RDA
Arm Type
Experimental
Arm Description
Participants to brush with 1.5 g of low RDA gel to foam toothpaste containing 1450 ppm F - EU level as NaF. All study treatments contain 5% weight by weight (w/w) KNO3.
Arm Title
NaF/KNO3 toothpaste, Medium RDA
Arm Type
Experimental
Arm Description
Participants to brush with 1.5 g of medium RDA gel to foam toothpaste containing 1450 ppm F - EU level as NaF. All study treatments contain 5% w/w KNO3.
Arm Title
NaF/KNO3 toothpaste
Arm Type
Active Comparator
Arm Description
Participants to brush with 1.5 g of NaF/KNO3 toothpaste containing 1450 ppm F - EU level as NaF. All study treatments contain 5% w/w KNO3.
Arm Title
No fluoride/KNO3 toothpaste
Arm Type
Placebo Comparator
Arm Description
Participants to brush with a fluoride free toothpaste (0 ppmF). All study treatments contain 5% w/w KNO3.
Intervention Type
Drug
Intervention Name(s)
Sodium Fluoride
Intervention Description
Toothpaste containing 1450 ppm F - EU level as NaF.
Intervention Type
Drug
Intervention Name(s)
Potassium nitrate
Intervention Description
All study treatments contain 5% w/w KNO3.
Primary Outcome Measure Information:
Title
Relative Erosion Resistance (RER) of Enamel Specimens Post 4 Hours of Treatment Exposure
Description
Enamel specimens were exposed to dietary erosive challenge and set of five indentations within each specimen was measured. Decrease in the indentation length compared to the baseline indicates hardening of enamel surface. Enamel specimens were exposed to second erosion challenge to determine RER which compared the indentations values of enamel specimens at baseline (B), first erosive (E1) and second erosive challenge (E2). Percent RER was calculated by formula: [(E1-E2)/ (E1-B)]*100. Smaller the negative RER, better is treatment regimen in imparting resistance to enamel.
Time Frame
Baseline, 4 hours post treatment in each treatment period
Title
Surface Microhardness (SMH) Recovery of Enamel Specimens Post 4 Hours of Treatment Exposure
Description
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 rehardening of enamel surface. Percent SMH recovery was calculated from indentation values of enamel specimens at baseline (B), after in-situ hardening (R) and after first erosive challenge (E1) using formula: [(E1- R)/ (E1-B)]*100. A higher percentage values indicate a better outcome.
Time Frame
Baseline, 4 hours post treatment in each treatment period
Other Pre-specified Outcome Measures:
Title
RER of Enamel Specimens Post 2 Hours of Treatment Exposure
Description
Enamel specimens were exposed to dietary erosive challenge and set of five indentations within each specimen was measured. Decrease in the indentation length compared to the baseline indicates hardening of enamel surface. Enamel specimens were exposed to second erosion challenge to determine RER which compared the indentations values of enamel specimens at baseline (B), first erosive (E1) and second erosive challenge (E2). Percent RER was calculated by formula: [(E1-E2)/ (E1-B)]*100. Smaller the negative RER, better is treatment regimen in imparting resistance to enamel.
Time Frame
Baseline, 2 hours post treatment in each treatment period
Title
SMH Recovery of Enamel Specimens Post 2 Hours of Treatment Exposure
Description
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 rehardening of enamel surface. Percent SMH recovery was calculated from indentation values of enamel specimens at baseline (B), after in-situ hardening (R) and after first erosive challenge (E1) using formula: [(E1- R)/ (E1-B)]*100. A higher percentage values indicate a better outcome.
Time Frame
Baseline, 2 hours post treatment in each treatment period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
General and Oral Health: Good general health with (in the opinion of the investigator) no clinically OST and OHT examinations.
Oral Requirements:
An intact maxillary dental arch suitable for the retention of the palatal appliance and an intact mandibular dental arch. Subjects may have fixed bridges replacing missing teeth.
A gum base stimulated whole saliva flow rate ≥ 0.8 g/min and an unstimulated whole saliva flow rate ≥ 0.2 g/min.
Contraception: Women of childbearing potential who are, in the opinion of the investigator, practicing a reliable method of contraception.
Exclusion Criteria:
Oral Health:
Current active caries or periodontal disease that may compromise the study or the health of the subjects.
Lesions of the oral cavity that could interfere with the study evaluations, including severe gingivitis, grossly carious lesions, periodontitis and other severe periodontal disease.
Allergy/Intolerance: Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
Clinical Study/Experimental Medication:
Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit
Previous participation in this study
Substance abuse: Recent history (within the last year) of alcohol or other substance abuse.
Pregnancy: Women who are pregnant or who are intending to become pregnant over the duration of the study
Breast-feeding: Women who are breast-feeding
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
Learn more about this trial
Evaluation of Efficacy of Experimental Gel to Foam Dentifrices in Dental Erosion
We'll reach out to this number within 24 hrs