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

Dental Erosion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01657903
• Other study ID #: Z6961385
• Status: Completed
• Phase: N/A
• First received: August 2, 2012
• Last updated: January 22, 2015
• Start date: November 2011
• Est. completion date: February 2012

Study information

• Verified date: July 2014
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acid Wear
• Dental Erosion
• Tooth Erosion

Intervention

Drug:
• Sodium Fluoride
Toothpaste containing 1450 ppm F - EU level as NaF.
• Potassium nitrate
All study treatments contain 5% w/w KNO3.

Locations

Country	Name	City	State
United States	Indiana University School of Dentistry	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	RER of Enamel Specimens Post 2 Hours of Treatment Exposure	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.	Baseline, 2 hours post treatment in each treatment period	No
Other	SMH Recovery of Enamel Specimens Post 2 Hours of Treatment Exposure	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.	Baseline, 2 hours post treatment in each treatment period	No
Primary	Relative Erosion Resistance (RER) of Enamel Specimens Post 4 Hours of Treatment Exposure	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.	Baseline, 4 hours post treatment in each treatment period	No
Primary	Surface Microhardness (SMH) Recovery of Enamel Specimens Post 4 Hours of Treatment Exposure	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.	Baseline, 4 hours post treatment in each treatment period	No