Evaluation of Plaque Fluid Fluoride Retention From Fluoride Toothpastes

NCT00708305 | Completed Phase 3 Results

• 1 other identifier: T3508570
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Caries

Keywords

toothpaste; plaque fluid; fluoride

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Natural Log Transformed AUC for Fluoride Concentration in Plaque Fluid Between 0-4 Hours

  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

  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

  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

  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

  Plaque samples were collected at baseline, 2 hour post single application of study treatment

Study Arms (4)

NaF toothpaste (1450 parts per million [ppm] fluoride [F])

EXPERIMENTAL

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)

NaF toothpaste (1400ppmF)

ACTIVE COMPARATOR

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)

Sodium monofluorophosphate (NaMFP)/ NaF toothpaste (1450ppmF))

ACTIVE COMPARATOR

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)

Placebo toothpaste (0ppmF)

PLACEBO COMPARATOR

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

Interventions

Sodium Fluoride (NaF) DRUG

Different fluoride toothpastes containing between 1400ppmF - 1450ppmF of fluoride as NaF

Also known as: fluoride

NaF toothpaste (1400ppmF); NaF toothpaste (1450 parts per million [ppm] fluoride [F]); Sodium monofluorophosphate (NaMFP)/ NaF toothpaste (1450ppmF))

Placebo DRUG

Fluoride free toothpaste (0ppmF)

Placebo toothpaste (0ppmF)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

Indiana University School of Dentistry

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Dental Caries

Interventions

Sodium Fluoride; Fluorides

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Hydrofluoric Acid; Fluorine Compounds; Inorganic Chemicals; Sodium Compounds; Cariostatic Agents; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Anions; Ions; Electrolytes

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2008
• First Posted: July 2, 2008
• Study Start: June 1, 2008
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: January 1, 2015
• Results First Posted: June 10, 2013

Record last verified: 2014-12

Locations

US (1)