In Situ Caries of Fluoride Toothpastes

NCT00708123 | Completed Phase 3 Results

• 1 other identifier: T3157503
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Healthy Subjects; Partial Denture Wearers; Caries

Keywords

remineralization; enamel; fluoride; caries; in situ

Outcome Measures

Primary Outcomes (1)

• Mean Percentage Surface Microhardness Recovery (%SMHR) of Enamel Specimens Exposed to NaF/Carbopol Toothpaste (1400 ppmF), NaF Toothpaste (1350ppmF) Compared to NaMFP/NaF Toothpaste (1450ppmF)

  %SMHR test was used to assess mineralization status of enamel specimens using a Wilson 2100 Hardness tester. %SMHR 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. %SMHR was calculated from indentation values of enamel specimens at baseline (B), after intra-oral exposure (R) and after in-vitro demineralization (D) using formula: \[(D-R)/ (D-B)\]\*100.

  Baseline to 14 days

Secondary Outcomes (2)

• Mean %SMHR of Enamel Specimens Exposed to NaF/Carbopol Toothpaste (1400 ppmF), NaF Toothpaste (1350ppmF), NaMFP/NaF Toothpaste (1450ppmF), NaF Toothpaste (250ppmF) and Placebo Toothpaste (0ppmF)

  Baseline to 14 days

• Adjusted Mean Change From Baseline in Enamel Fluoride Uptake

  Baseline to 14 days

Study Arms (5)

Sodium Fluoride (NaF) toothpaste[1350 parts per million(ppm)F]

ACTIVE COMPARATOR

Participants to brush their natural teeth twice daily with a full ribbon of NaF toothpaste (1350 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth.

Drug: Sodium fluoride toothpaste

NaF/Carbopol toothpaste (1400 ppm F)

EXPERIMENTAL

Participants to brush their natural teeth twice daily with a full ribbon of NaF and 0.5% carbopol toothpaste (1450 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth.

Drug: Sodium fluoride toothpaste

NaMFP/NaF toothpaste (1450 ppm F)

ACTIVE COMPARATOR

Participants to brush their natural teeth twice daily with a full ribbon of NaMFPand NaF toothpaste (1450 ppm F - 1000 ppm F as NaMFP and 450 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth.

Drug: Sodium fluoride toothpaste

NaF toothpaste (250 ppm F)

ACTIVE COMPARATOR

Participants to brush their natural teeth twice daily with a full ribbon of NaF toothpaste (250 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth.

Drug: Sodium fluoride toothpaste

Placebo toothpaste (0 ppm F)

PLACEBO COMPARATOR

Participants to brush their natural teeth twice daily with a full ribbon of fluoride free toothpaste (0 ppm F) for one timed minute, after removing their partial denture from their mouth.

Drug: Placebo toothpaste

Interventions

Sodium fluoride toothpaste DRUG

Various fluoride toothpastes containing 1350 ppm F, 1450 ppm F, 1400 ppm F and 250 ppm F

Also known as: Fluoride

NaF toothpaste (250 ppm F); NaF/Carbopol toothpaste (1400 ppm F); NaMFP/NaF toothpaste (1450 ppm F); Sodium Fluoride (NaF) toothpaste[1350 parts per million(ppm)F]

Placebo toothpaste DRUG

Fluoride free toothpaste (0 ppm F)

Placebo toothpaste (0 ppm F)

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 78 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/or relevant abnormalities of medical history or oral examination that could interfere with subject safety during the study period.
• Diagnosis: Oral - i. Currently living in the Indianapolis area which is a fluoridated community (1 ppm F). ii. Currently wearing a removable mandibular partial denture with sufficient room in the posterior buccal flange area to accommodate two enamel specimens (required dimensions 12 x 7 millimeters (mm). iii. Willing and capable of wearing their removable partial dentures 24 hours per day during each two week treatment period. iv.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 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. No pregnancy test will be required.
• 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.
• Clinical Study/Experimental Medication:Participation in another clinical study or receipt of an investigational drug within 30 days of the first treatment visit, with the exception of study T3157495 where the wash in period prior to treatment is sufficient.
• Antibiotics:Currently taking antibiotics or have taken antibiotics in the 2 weeks prior to the screening visit.
• Fluoride:Taking fluoride supplements for medical reasons.
• Dental Health: Current active caries or periodontal disease that may compromise the study or health of the subjects.
• Personnel: a) A member of the site study staff, b) An employee of the sponsor, c) Any employee of any toothpaste manufacturer or their spouse or family member.

Sponsors & Collaborators

• GlaxoSmithKline: lead

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: 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: November 1, 2007
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2008
• Last Updated: April 22, 2013
• Results First Posted: November 19, 2012

Record last verified: 2013-03