Experimental Gel to Foam Dentifrice Formulations in Situ Remineralisation Study - Full Text View

Purpose

Two new GSK gel to foam dentifrices (low and medium RDA) each containing 1450 parts per million (ppm) of Fluoride (F) as Sodium Fluoride (NaF) are intended for use in this clinical as study treatments. A placebo dentifrice (0 ppm F) and a GSK marketed product, Sensodyne Pronamel toothpaste 1450 ppm F as NaF are also intended for use in this trial.

Condition	Intervention
Acid Erosion	Drug: Sodium Fluoride Drug: Placebo Drug: potasium 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:

Drug Information available for: Sodium fluoride Fluorine Fluoride

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Adjusted mean percentage relative erosion resistance (RER) of enamel specimens exposed to extra-oral erosion challenges while being treated with NaF toothpastes compared to Placebo toothpaste [ 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.
Adjusted mean percentage surface microhardness (SMH) recovery of enamel specimens exposed to extra-oral erosion challenges while being treated with NaF toothpastes compared to Placebo toothpaste [ 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: Low Level Relative Dentine Abrasivity gel to foam toothpaste with low level relative dentine Abrasivity (RDA) (approx. RDA of 35) and high level of of Sodium Fluoride	Drug: Sodium Fluoride active Drug: potasium nitrate active
Active Comparator: Sodium Fluoride Toothpaste toothpaste with high level of NaF	Drug: Sodium Fluoride active
Placebo Comparator: Placebo Toothpaste fluoride free formulation	Drug: Placebo no active
Experimental: Medium Level Relative Dentine Abrasivity gel to foam toothpaste with medium level relative dentine Abrasivity (RDA) (approx. RDA of 100) and high level of of Sodium Fluoride	Drug: potasium nitrate active

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
1. 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.
2. A gum base stimulated whole saliva flow rate ≥ 0.8 g/min and an unstimulated whole saliva flow rate ≥ 0.2 g/min.
  
  6. Contraception: Women of childbearing potential who are, in the opinion of the investigator, practicing a reliable method of contraception.
  
  Exclusion Criteria:
Oral Health
1. Current active caries or periodontal disease that may compromise the study or the health of the subjects.
2. Lesions of the oral cavity that could interfere with the study evaluations, including severe gingivitis, grossly carious lesions, periodontitis and other severe periodontal disease.
  
  4. Allergy/Intolerance: Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.

Contacts and Locations

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:	August 16, 2012
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Fluorides
Sodium Fluoride
Cariostatic Agents

Protective Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013