In Situ Caries Efficacy of Fluoride Toothpastes

NCT00708097 | Completed Phase 3 Results

• 1 other identifier: T3508565
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

This study is to evaluate the effect of fluoride dentifrices on enamel with artificial caries lesions in an in situ model

Conditions

Caries

Keywords

fluoride; in situ; remineralization; enamel; caries

Outcome Measures

Primary Outcomes (1)

• Percentage Surface Microhardness Recovery (%SMHR) of Sound Enamel Specimens Exposed to NaF Toothpaste (1450ppmF) and NaF Toothpaste (1400ppmF)

  SMH test was used to assess mineral status of partially demineralized enamel specimens using 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/demineralization while decrease in the indentation represents rehardening/ remineralization of enamel surface. Percent SMHR was calculated from indentation values of enamel specimens at baseline(B); after intra-oral exposure(R) on Day 14; and after in-vitro demineralization(D) on Day 14 using formula \[(D-R)/(D-B)\]\*100.

  Baseline to 14 days

Secondary Outcomes (4)

• Percentage SMHR of Sound Enamel Specimens Exposed to NaF Toothpaste (1450ppmF), NaF Toothpaste (1400ppmF), NaMFP/NaF Toothpaste (1450ppmF), NaF Toothpaste (675ppmF) and Placebo Toothpaste (0ppmF)

  Baseline to 14 days

• Percentage SMHR of Demineralized Enamel Specimens Exposed to NaF Toothpaste (1450ppmF), NaF Toothpaste (1400ppmF), NaF Toothpaste (675ppmF), NaMFP/NaF Toothpaste(1450ppmF) and Placebo Toothpaste (0ppmF)

  Baseline to 14 days

• Enamel Fluoride Uptake (Sound Enamel Specimens)

  Baseline to 14 days

• Enamel Fluoride Uptake (Demineralized Specimens)

  Baseline to 14 days

Study Arms (5)

NaF toothpaste(1450 ppmF)

EXPERIMENTAL

Study toothpaste containing 1450 ppm F as NaF and 0.4% carbopol as excipient.

Drug: NaF

NaF toothpaste (1400 ppmF)

ACTIVE COMPARATOR

Study toothpaste containing 1400 ppm F as NaF

Drug: NaF

NaMFP/NaF toothpaste (1450 ppmF)

ACTIVE COMPARATOR

Reference toothpaste containing 1000 ppm F as NaMFP and 450 ppm F as NaF

Drug: NaF; Drug: NaMFP

NaF toothpaste (675 ppmF)

ACTIVE COMPARATOR

Study toothpaste containing 675 ppm F as NaF

Drug: NaF

Placebo toothpaste (0 ppmF)

PLACEBO COMPARATOR

Fluoride free placebo toothpaste (0 ppm F)

Drug: Placebo

Interventions

NaF DRUG

Fluoride

Also known as: Fluoride

NaF toothpaste (1400 ppmF); NaF toothpaste (675 ppmF); NaF toothpaste(1450 ppmF); NaMFP/NaF toothpaste (1450 ppmF)

Placebo DRUG

Placebo

Placebo toothpaste (0 ppmF)

NaMFP DRUG

Fluoride

NaMFP/NaF toothpaste (1450 ppmF)

Eligibility Criteria

• Age: 18 Years - 78 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Age:Aged between 18 and 80 years.
• Compliance:Understands and is willing, able and likely to comply with all study procedures and restrictions.
• General Health:Good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history or physical examination.
• Fluoride:Currently living in the Indianapolis, Indiana area and not taking fluoride supplements for medical reasons
• Dentures: a)Currently wearing a removable mandibular partial denture with sufficient room in both posterior buccal flange areas to accommodate two enamel specimens on each side, four specimens in total - required dimensions 12 x 7 millimeter (mm) per side. b) Willing to have their denture modified to accommodate enamel test specimens and willing and capable of wearing their removable mandibular partial dentures 24 hours per day during the experimental periods
• Dental health: Have no current active caries or periodontal disease that may compromise the study or the health of the subjects and all restorations in a good state of repair
• Salivary flow:Have a salivary flow rate in the range of normal values (unstimulated whole saliva flow rate = 0.2 milliliter (mL)/minute; gum base stimulated whole saliva flow rate = 0.8 mL/minute)

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.
• Breast-feeding:Women who are breast-feeding.
• Allergy/Intolerance: Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
• Antibiotics: Currently taking antibiotics or have taken antibiotics in the two weeks prior to the screening visit
• Clinical Study/Experimental Medication: a) Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit.b) Participation in another GSKCH investigational dental product study within 7 days of first study treatment c)Previous participation in this study.
• Substance abuse: Recent history (within the last year) of alcohol or other substance abuse.
• Personnel:a) A member of the site study staff living in same household.b)An employee of the sponsor. c) Any employee of any toothpaste manufacturer or their spouse or family member

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

Indiana University School of Dentistry

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Interventions

Fluorides

Intervention Hierarchy (Ancestors)

Anions; Ions; Electrolytes; Inorganic Chemicals; Hydrofluoric Acid; Fluorine Compounds

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: SINGLE
• Who Masked: 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: April 1, 2008
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: January 1, 2015
• Results First Posted: June 24, 2013

Record last verified: 2014-12

Locations

US (1)