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Experimental Dentifrice Remineralization/Fluoride Uptake in an in Situ Model

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00752089
First received: September 11, 2008
Last updated: October 17, 2016
Last verified: May 2016
  Purpose
The purpose of this study is to determine whether an experimental fluoridated dentifrice is effective in the treatment of dental caries

Condition Intervention Phase
Dental Erosion
Drug: NaF/ KNO3/isopentane Dentifrice
Drug: NaF/KNO3 Dentifrice
Drug: NaF Dentifrice
Other: Placebo Dentifrice
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Exploratory Evaluation of an Experimental Fluoride Dentifrice Formulation Using an in Situ Remineralization/Fluoride Uptake Model

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Percentage Surface Micro-hardness Recovery (SMHR) of Enamel Specimens [ Time Frame: Baseline to 14 days ]
    SMH test was used to assess mineralization status of enamel specimens using a 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 while decrease in the indentation length represents re-hardening of enamel surface. Percent 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.


Secondary Outcome Measures:
  • Adjusted Mean Change From Baseline in Enamel Fluoride Uptake [ Time Frame: Baseline to 14 days ]
    Enamel fluoride uptake was determined using the microdrill enamel biopsy technique. The amount of fluoride uptake by enamel was calculated based on the amount of fluoride (F) divided by the area of the enamel cores and expressed as ug*F/cm^3. The difference between treatments was calculated with respect to fluoride uptake by enamel.


Enrollment: 20
Study Start Date: September 2007
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sodium fluoride/potassium nitrate/Isopentane dentifrice
Participants to brush their teeth for one timed minute twice daily with a gel to foam dentifrice containing active ingredients: 1450 ppm F as sodium fluoride (NaF) and 5% potassium nitrate (KNO3) and isopentane as an excipient ingredient.
Drug: NaF/ KNO3/isopentane Dentifrice
Experimental toothpaste
Experimental: NaF/KNO3 Dentifrice
Participants to brush their teeth for one timed minute twice daily with a gel to foam dentifrice, containing as active ingredients: 1450 ppm NaF and 5% KNO3 but no isopentane.
Drug: NaF/KNO3 Dentifrice
Experimental toothpaste
Active Comparator: NaF Dentifrice
Participants to brush their teeth for one timed minute twice daily with a dentifrice containing 1450 ppm F as NaF.
Drug: NaF Dentifrice
Active comparator
Placebo Comparator: Placebo Dentifrice
Participants to brush their teeth for one timed minute twice daily with a fluoride free dentifrice (0 ppm F).
Other: Placebo Dentifrice
Placebo comparator

Detailed Description:
Topical fluorides have been proven to be clinically effective in the prevention of dental caries. It is generally agreed that anti-caries effect of fluoride (F) is mainly by decreasing the rate of enamel demineralization and enhancing the rate of enamel remineralization. An in-situ Surface Micro-hardness (SMH) test is widely used to evaluate enamel demineralization and remineralization during the caries process. Determination of fluoride uptake in-situ also provides better estimation of true fluoride bioavailability of fluoride dentifrice products. In this study, an in-situ remineralization fluoride uptake model will be used to compare the efficacy of experimental dentifrice with a marketed dentifrice and placebo dentifrice. Participants wore partial dentures containing two partially demineralized enamel specimens for two weeks- 24 hours per day, except when brushing (twice daily) with test dentifrice. Following each treatment period, the enamel specimens were analyzed for SMH recovery and fluoride uptake through microdrill enamel biopsy technique.
  Eligibility

Ages Eligible for Study:   18 Years to 78 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Age: Aged between 18 and 78
  2. Fluoride: Currently living in the Indianapolis area which has a fluoridated water supply (1 ppm F) and not taking fluoride supplements for medical reasons
  3. Dentures: 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 mm). Willing and capable of wearing their removable partial dentures 24 hours per day during the experimental periods
  4. Dental health:Have no current active caries or periodontal disease that may compromise the study or the health of the participants and all restorations in a good state of repair
  5. Salivary flow:Have a salivary flow rate in the range of normal values (unstimulated whole saliva flow rate ≥ 0.2 mL/min; gum base stimulated whole saliva flow rate ≥ 0.8 mL/min
  6. Compliance: Understands and is willing, able and likely to comply with all study procedures and restrictions
  7. 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
  8. 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 participant safety during the study period

Exclusion Criteria:

  1. Antibiotics:Currently taking antibiotics or have taken antibiotics in the two weeks prior to the screening visit
  2. Allergy/Intolerance:Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients
  3. Pregnancy:Women who are known to be pregnant or who are intending to become pregnant over the duration of the study.
  4. Breast-feeding:Women who are breast-feeding.
  5. Clinical Study/Experimental Medication: Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit
  6. Personnel:An employee of the sponsor or the study site who is directly involved in the study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00752089

Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00752089     History of Changes
Other Study ID Numbers: Z3120510
Study First Received: September 11, 2008
Results First Received: September 7, 2011
Last Updated: October 17, 2016

Keywords provided by GlaxoSmithKline:
enamel fluoride uptake
erosion
enamel remineralization

Additional relevant MeSH terms:
Tooth Erosion
Tooth Wear
Tooth Diseases
Stomatognathic Diseases
Sodium Fluoride
Fluorides
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on March 30, 2017