Evaluation of Efficacy of Experimental Gel to Foam Dentifrices in Dental Erosion

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01657903
First received: August 2, 2012
Last updated: July 11, 2013
Last verified: August 2012
  Purpose

The purpose of this study is to compare and evaluate the ability of two European Union (EU) regulated gel to foam toothpaste formulations versus a non-fluoride toothpaste using a modified in-situ model of dental erosion and remineralization. A positive control i.e fluoride containing toothpaste marketed in EU will also be compared to non-fluoride toothpaste.


Condition Intervention
Dental Erosion
Acid Wear
Drug: Sodium Fluoride
Drug: Potassium nitrate

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: A Placebo Controlled Study to Evaluate the Effectiveness of Experimental Foaming Gel Toothpastes Using an In-situ Erosion Remineralization Model

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Relative erosion resistance (RER) of enamel specimens post 4 hours of treatment exposure [ Time Frame: Baseline, 4 hours post treatment in each treatment period ] [ Designated as safety issue: No ]
    Enamel specimens were exposed to dietary erosive challenge and set of five indentations within each specimen was measured. Decrease in the indentation length compared to the baseline indicates hardening of enamel surface. Enamel specimens were exposed to second erosion challenge to determine RER which compared the indentations values of enamel specimens at baseline (B), first erosive (E1) and second erosive challenge (E2). Percent RER was calculated by formula: [(E1-E2)/ (E1-B)]*100. Smaller the negative RER, better is treatment regimen in imparting resistance to enamel.

  • Surface microhardness (SMH) recovery of enamel specimens post 4 hours of treatment exposure [ Time Frame: Baseline, 4 hours post treatment in each treatment period ] [ Designated as safety issue: No ]
    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 rehardening of enamel surface. Percent SMH recovery was calculated from indentation values of enamel specimens at baseline (B), after in-situ hardening (R) and after first erosive challenge (E1) using formula: [(E1- R)/ (E1-B)]*100.


Enrollment: 56
Study Start Date: November 2011
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NaF/KNO3 toothpaste, Low RDA
Participants to brush with 1.5 g of low RDA gel to foam toothpaste containing 1450 ppm F - EU level as NaF. All study treatments contain 5% weight by weight (w/w) KNO3.
Drug: Sodium Fluoride
Toothpaste containing 1450 ppm F - EU level as NaF.
Drug: Potassium nitrate
All study treatments contain 5% w/w KNO3.
Experimental: NaF/KNO3 toothpaste, Medium RDA
Participants to brush with 1.5 g of medium RDA gel to foam toothpaste containing 1450 ppm F - EU level as NaF. All study treatments contain 5% w/w KNO3.
Drug: Sodium Fluoride
Toothpaste containing 1450 ppm F - EU level as NaF.
Drug: Potassium nitrate
All study treatments contain 5% w/w KNO3.
Active Comparator: NaF/KNO3 toothpaste
Participants to brush with 1.5 g of NaF/KNO3 toothpaste containing 1450 ppm F - EU level as NaF. All study treatments contain 5% w/w KNO3.
Drug: Sodium Fluoride
Toothpaste containing 1450 ppm F - EU level as NaF.
Drug: Potassium nitrate
All study treatments contain 5% w/w KNO3.
Placebo Comparator: No fluoride/KNO3 toothpaste
Participants to brush with a fluoride free toothpaste (0 ppmF). All study treatments contain 5% w/w KNO3.
Drug: Potassium nitrate
All study treatments contain 5% w/w KNO3.

Detailed Description:

The aim of this study is to assess the remineralization effects of two EU gel to foam toothpaste formulations with 1450 parts per million (ppm) of fluoride as sodium fluoride (NaF) and 5% potassium nitrate (KNO3) versus a non-fluoride (0 ppm F)/KNO3 toothpaste as a negative control. The two experimental gel to foam toothpaste formulations differ in their relative dentine abrasivity (RDA) values which is an in-vitro measure of a toothpaste abrasivity to the dentinal tissues. A marketed toothpaste containing NaF and KNO3 will serve as a positive control.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • General and Oral Health: Good general health with (in the opinion of the investigator) no clinically OST and OHT examinations.
  • Oral Requirements:

    • An intact maxillary dental arch suitable for the retention of the palatal appliance and an intact mandibular dental arch. Subjects may have fixed bridges replacing missing teeth.
    • A gum base stimulated whole saliva flow rate ≥ 0.8 g/min and an unstimulated whole saliva flow rate ≥ 0.2 g/min.
  • Contraception: Women of childbearing potential who are, in the opinion of the investigator, practicing a reliable method of contraception.

Exclusion Criteria:

  • Oral Health:

    • Current active caries or periodontal disease that may compromise the study or the health of the subjects.
    • Lesions of the oral cavity that could interfere with the study evaluations, including severe gingivitis, grossly carious lesions, periodontitis and other severe periodontal disease.
  • 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
    • Previous participation in this study
  • Substance abuse: Recent history (within the last year) of alcohol or other substance abuse.
  • Pregnancy: Women who are pregnant or who are intending to become pregnant over the duration of the study
  • Breast-feeding: Women who are breast-feeding
  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: NCT01657903

Locations
United States, Indiana
Indiana University School of Dentistry
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01657903     History of Changes
Other Study ID Numbers: Z6961385
Study First Received: August 2, 2012
Last Updated: July 11, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Tooth Erosion
Stomatognathic Diseases
Tooth Diseases
Tooth Wear
Fluorides
Listerine
Sodium Fluoride
Anti-Infective Agents
Anti-Infective Agents, Local
Cariostatic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014