Evaluation of Plaque Fluid Fluoride Retention From Fluoride Toothpastes

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluation of Plaque Fluid Fluoride Retention From Fluoride Toothpastes

Conditions
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Dental Caries

Intervention / Treatment
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* Drug: Sodium Fluoride (NaF)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NaF toothpaste (1450 parts per million [ppm] fluoride [F])<br>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. | Drug: Sodium Fluoride (NaF)<br>* Different fluoride toothpastes containing between 1400ppmF - 1450ppmF of fluoride as NaF<br>* Other names: fluoride;|
| Active Comparator: NaF toothpaste (1400ppmF)<br>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. | Drug: Sodium Fluoride (NaF)<br>* Different fluoride toothpastes containing between 1400ppmF - 1450ppmF of fluoride as NaF<br>* Other names: fluoride;|
| Active Comparator: Sodium monofluorophosphate (NaMFP)/ NaF toothpaste (1450ppmF))<br>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. | Drug: Sodium Fluoride (NaF)<br>* Different fluoride toothpastes containing between 1400ppmF - 1450ppmF of fluoride as NaF<br>* Other names: fluoride;|
| Placebo Comparator: Placebo toothpaste (0ppmF)<br>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. | Drug: Placebo<br>* Fluoride free toothpaste (0ppmF)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Plaque samples collected at 15 minutes, 30 minutes, 1 hour, 2 hours and 4 hours post single application of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Plaque samples collected at 15 minutes, 30 minutes, 1 hour, 2 hours and 4 hours post single application of treatment | 
| 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. | Plaque samples were collected at baseline, 15 minutes post single application of study treatment | 
| 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. | Plaque samples were collected at baseline, 30 minutes post single application of study treatment | 
| 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. | Plaque samples were collected at baseline, 1 hour post single application of study treatment | 
| 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. | Plaque samples were collected at baseline, 2 hour post single application of study treatment | 
| 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. | Plaque samples were collected at baseline, 4 hours post single application of study treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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toothpaste, plaque fluid, fluoride