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Completed

NCT Number: NCT01657903

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

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.

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Key information

Conditions

Dental Erosion Acid Wear Stomatognathic Diseases Tooth Demineralization Tooth Diseases Tooth Erosion Tooth Wear

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Indiana University School of Dentistry

Indianapolis, Indiana, 46202, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sodium Fluoride

Drug

Toothpaste containing 1450 ppm F - EU level as NaF.

Potassium Nitrate

Drug

All study treatments contain 5% w/w KNO3.

Primary outcomes

  1. Relative Erosion Resistance (RER) of Enamel Specimens Post 4 Hours of Treatment Exposure

    Time frame: Baseline, 4 hours post treatment in each treatment period

    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.

  2. Surface Microhardness (SMH) Recovery of Enamel Specimens Post 4 Hours of Treatment Exposure

    Time frame: Baseline, 4 hours post treatment in each treatment period

    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. A higher percentage values indicate a better outcome.

Other outcomes

  1. RER of Enamel Specimens Post 2 Hours of Treatment Exposure

    Time frame: Baseline, 2 hours post treatment in each treatment period

    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.

  2. SMH Recovery of Enamel Specimens Post 2 Hours of Treatment Exposure

    Time frame: Baseline, 2 hours post treatment in each treatment period

    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. A higher percentage values indicate a better outcome.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

A Placebo Controlled Study to Evaluate the Effectiveness of Experimental Foaming Gel Toothpastes Using an In-situ Erosion Remineralization Model

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Aug 6, 2012
Registry last updated
Jan 26, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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