Back to resultsEvaluation of Plaque Fluid Fluoride Retention From Fluoride Toothpastes
Primary Purpose
Dental Caries
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Sodium Fluoride (NaF)
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Dental Caries focused on measuring toothpaste, plaque fluid, fluoride
Eligibility Criteria
Inclusion Criteria:
- Age:Age 18 through 65 years.
- 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, specifically including diabetes or hypoglycemia.
- 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.
- Oral: a) Currently living in the Indianapolis, Indiana area and not taking fluoride supplements. b) Have a normal stimulated (= 0.8 ml/min) and unstimulated (= 0.2 ml/min) salivary flow rate. c) Have a full complement of natural teeth with the exception of third molars and teeth extracted for orthodontic reasons. Participants natural teeth must have at least one surface free of restoration in each interproximal embrasure. d) Produce at least 6mg of plaque at Screening Visit 2.
Exclusion Criteria:
- Pregnancy:Women who are known to be pregnant or who are intending to become pregnant over the duration of the study. No pregnancy test will be required.
- Breast-feeding:Women who are breast-feeding.
- Medical History:Current or relevant history of any serious, severe or unstable physical or psychiatric illness that would make the subject unlikely to fully complete the study or any that increases the risk to the subject.
- 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 1 at the start of the study with the exception of those participating in GSKCH study Z3170476.
- Medication: a) Currently taking antibiotics or have taken antibiotics in the two weeks prior to any treatment visit or during the study. b) Has a medical condition that would require prophylactic antibiotics prior to a dental cleaning.
- Dental: a) Current active caries or moderate to severe periodontal disease that may compromise the health of the participants or the study. b) Current use of chlorhexidine mouthrinse.
- Personnel: An employee of the sponsor or the study site who is directly involved in the conduct of the study.
Sites / Locations
- Indiana University School of Dentistry
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
NaF toothpaste (1450 parts per million [ppm] fluoride [F])
NaF toothpaste (1400ppmF)
Sodium monofluorophosphate (NaMFP)/ NaF toothpaste (1450ppmF))
Placebo toothpaste (0ppmF)
Arm Description
Participants brushed for one timed minute with 1.6g of NaF/silica and 0.4 percent carbopol toothpaste containing 1450ppmF as NaF. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
Participants brushed for one timed minute with 1.6g of NaF toothpaste containing 1400ppmF as NaF. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
Participants brushed for one timed minute with 1.6g of NaMFP/NaF toothpaste containing 1450ppmF from NaMFP and NaF. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
Participants brushed for one timed minute with 1.6g of fluoride free toothpaste. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
Outcomes
Primary Outcome Measures
Natural Log Transformed Area Under the Fluoride Concentration in Plaque Fluid by Time Curve (AUC) Between 0-4 Hours
To evaluate fluoride content, plaque samples were collected from the interproximal surfaces of the posterior teeth of participants using a standardized approach. Plaque fluid fluoride were calculated using a micro analytical method and in comparison to a standard fluoride curve constructed on the same day of the analysis. AUC was determined from 0-4hours using trapezoidal rule and natural log transformation was applied due to failure of assumption of normal distribution of data.
Secondary Outcome Measures
Natural Log Transformed AUC for Fluoride Concentration in Plaque Fluid Between 0-4 Hours
To evaluate fluoride content, plaque samples were collected from the interproximal surfaces of the posterior teeth of participants using a standardized approach. Plaque fluid fluoride were calculated using a micro analytical method and in comparison to a standard fluoride curve constructed on the same day of the analysis. AUC was determined from 0-4 hours using trapezoidal rule and natural log transformation was applied.due to failure of assumption of normal distribution of data.
Change From Baseline in Fluoride Concentration at 15 Minutes After Brushing With Study Treatments
Change from baseline at any time point for a treatment period was calculated as the median post brushing fluoride value at a time point minus the median baseline (pre-brushing) fluoride value for a treatment period.
Change From Baseline in Fluoride Concentration at 30 Minutes Post Brushing With Study Treatments
Change from baseline at any time point for a treatment period was calculated as the median post brushing fluoride value at a time point minus the median baseline (pre-brushing) fluoride value for a treatment period.
Change From Baseline in Fluoride Concentration at 1 Hour Post Brushing With Study Treatments
Change from baseline at any time point for a treatment period was calculated as the median post brushing fluoride value at a time point minus the median baseline (pre-brushing) fluoride value for a treatment period.
Change From Baseline in Fluoride Concentration at 2 Hours Post Brushing With Study Treatments
Change from baseline at any time point for a treatment period was calculated as the median post brushing fluoride value at a time point minus the median baseline (pre-brushing) fluoride value for a treatment period.
Change From Baseline in Fluoride Concentration at 4 Hours Post Brushing With Study Treatments
Change from baseline at any time point for a treatment period was calculated as the median post brushing fluoride value at a time point minus the median baseline (pre-brushing) fluoride value for a treatment period.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00708305
Brief Title
Evaluation of Plaque Fluid Fluoride Retention From Fluoride Toothpastes
Official Title
Evaluation of Plaque Fluid Fluoride Retention From Fluoride Toothpastes
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
October 2008 (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 investigate the efficacy of different sodium fluoride (NaF) containing toothpastes in prevention of dental caries. Change from baseline fluoride data at various time points up to four hours after a single brushing with NaF containing toothpastes will be evaluated.
Detailed Description
Topical fluorides in a wide variety of delivery systems have been proven to be clinically effective in the prevention of dental caries. It is generally agreed that fluoride has its anti-caries effect mainly by decreasing the rate of enamel demineralization and enhancing the rate of enamel remineralization. There is a general consensus that level of fluoride in plaque fluid, may be directly related to the anti caries effects of fluoride. Also, fluoride levels in the oral fluids decrease rapidly after topical fluoride application, mainly due to the diluting and washing effect of saliva followed by periodic swallowing. To evaluate fluoride content, plaque samples will be collected from the interproximal surfaces of the posterior teeth of participants using a standardized approach. Plaque fluid fluoride will be calculated using a micro analytical method and in comparison to a standard fluoride curve constructed on the same day of the analysis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries
Keywords
toothpaste, plaque fluid, fluoride
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
65 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NaF toothpaste (1450 parts per million [ppm] fluoride [F])
Arm Type
Experimental
Arm Description
Participants brushed for one timed minute with 1.6g of NaF/silica and 0.4 percent carbopol toothpaste containing 1450ppmF as NaF. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
Arm Title
NaF toothpaste (1400ppmF)
Arm Type
Active Comparator
Arm Description
Participants brushed for one timed minute with 1.6g of NaF toothpaste containing 1400ppmF as NaF. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
Arm Title
Sodium monofluorophosphate (NaMFP)/ NaF toothpaste (1450ppmF))
Arm Type
Active Comparator
Arm Description
Participants brushed for one timed minute with 1.6g of NaMFP/NaF toothpaste containing 1450ppmF from NaMFP and NaF. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
Arm Title
Placebo toothpaste (0ppmF)
Arm Type
Placebo Comparator
Arm Description
Participants brushed for one timed minute with 1.6g of fluoride free toothpaste. Participants then swished the slurry around their mouth for 10 seconds, expectorated, then rinsed with water for 10 seconds.
Intervention Type
Drug
Intervention Name(s)
Sodium Fluoride (NaF)
Other Intervention Name(s)
fluoride
Intervention Description
Different fluoride toothpastes containing between 1400ppmF - 1450ppmF of fluoride as NaF
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Fluoride free toothpaste (0ppmF)
Primary Outcome Measure Information:
Title
Natural Log Transformed Area Under the Fluoride Concentration in Plaque Fluid by Time Curve (AUC) Between 0-4 Hours
Description
To evaluate fluoride content, plaque samples were collected from the interproximal surfaces of the posterior teeth of participants using a standardized approach. Plaque fluid fluoride were calculated using a micro analytical method and in comparison to a standard fluoride curve constructed on the same day of the analysis. AUC was determined from 0-4hours using trapezoidal rule and natural log transformation was applied due to failure of assumption of normal distribution of data.
Time Frame
Plaque samples collected at 15 minutes, 30 minutes, 1 hour, 2 hours and 4 hours post single application of treatment
Secondary Outcome Measure Information:
Title
Natural Log Transformed AUC for Fluoride Concentration in Plaque Fluid Between 0-4 Hours
Description
To evaluate fluoride content, plaque samples were collected from the interproximal surfaces of the posterior teeth of participants using a standardized approach. Plaque fluid fluoride were calculated using a micro analytical method and in comparison to a standard fluoride curve constructed on the same day of the analysis. AUC was determined from 0-4 hours using trapezoidal rule and natural log transformation was applied.due to failure of assumption of normal distribution of data.
Time Frame
Plaque samples collected at 15 minutes, 30 minutes, 1 hour, 2 hours and 4 hours post single application of treatment
Title
Change From Baseline in Fluoride Concentration at 15 Minutes After Brushing With Study Treatments
Description
Change from baseline at any time point for a treatment period was calculated as the median post brushing fluoride value at a time point minus the median baseline (pre-brushing) fluoride value for a treatment period.
Time Frame
Plaque samples were collected at baseline, 15 minutes post single application of study treatment
Title
Change From Baseline in Fluoride Concentration at 30 Minutes Post Brushing With Study Treatments
Description
Change from baseline at any time point for a treatment period was calculated as the median post brushing fluoride value at a time point minus the median baseline (pre-brushing) fluoride value for a treatment period.
Time Frame
Plaque samples were collected at baseline, 30 minutes post single application of study treatment
Title
Change From Baseline in Fluoride Concentration at 1 Hour Post Brushing With Study Treatments
Description
Change from baseline at any time point for a treatment period was calculated as the median post brushing fluoride value at a time point minus the median baseline (pre-brushing) fluoride value for a treatment period.
Time Frame
Plaque samples were collected at baseline, 1 hour post single application of study treatment
Title
Change From Baseline in Fluoride Concentration at 2 Hours Post Brushing With Study Treatments
Description
Change from baseline at any time point for a treatment period was calculated as the median post brushing fluoride value at a time point minus the median baseline (pre-brushing) fluoride value for a treatment period.
Time Frame
Plaque samples were collected at baseline, 2 hour post single application of study treatment
Title
Change From Baseline in Fluoride Concentration at 4 Hours Post Brushing With Study Treatments
Description
Change from baseline at any time point for a treatment period was calculated as the median post brushing fluoride value at a time point minus the median baseline (pre-brushing) fluoride value for a treatment period.
Time Frame
Plaque samples were collected at baseline, 4 hours post single application of study treatment
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:
Age:Age 18 through 65 years.
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, specifically including diabetes or hypoglycemia.
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.
Oral: a) Currently living in the Indianapolis, Indiana area and not taking fluoride supplements. b) Have a normal stimulated (= 0.8 ml/min) and unstimulated (= 0.2 ml/min) salivary flow rate. c) Have a full complement of natural teeth with the exception of third molars and teeth extracted for orthodontic reasons. Participants natural teeth must have at least one surface free of restoration in each interproximal embrasure. d) Produce at least 6mg of plaque at Screening Visit 2.
Exclusion Criteria:
Pregnancy:Women who are known to be pregnant or who are intending to become pregnant over the duration of the study. No pregnancy test will be required.
Breast-feeding:Women who are breast-feeding.
Medical History:Current or relevant history of any serious, severe or unstable physical or psychiatric illness that would make the subject unlikely to fully complete the study or any that increases the risk to the subject.
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 1 at the start of the study with the exception of those participating in GSKCH study Z3170476.
Medication: a) Currently taking antibiotics or have taken antibiotics in the two weeks prior to any treatment visit or during the study. b) Has a medical condition that would require prophylactic antibiotics prior to a dental cleaning.
Dental: a) Current active caries or moderate to severe periodontal disease that may compromise the health of the participants or the study. b) Current use of chlorhexidine mouthrinse.
Personnel: An employee of the sponsor or the study site who is directly involved in the conduct of the study.
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 Plaque Fluid Fluoride Retention From Fluoride Toothpastes
We'll reach out to this number within 24 hrs