Clinical trial NCT01657903: Evaluation of Efficacy of Experimental Gel to Foam Dentifrices in Dental Erosion
Official title: A Placebo Controlled Study to Evaluate the Effectiveness of Experimental Foaming Gel Toothpastes Using an In-situ Erosion Remineralization Model
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Erosion
Acid Wear
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2012-08-06
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: Relative Erosion Resistance (RER) of Enamel Specimens Post 4 Hours of Treatment Exposure
timeFrame: Baseline, 4 hours post treatment in each treatment period
measure: Surface Microhardness (SMH) Recovery of Enamel Specimens Post 4 Hours of Treatment Exposure
timeFrame: Baseline, 4 hours post treatment in each treatment period
Secondary outcomes:
Other outcomes:
measure: RER of Enamel Specimens Post 2 Hours of Treatment Exposure
timeFrame: Baseline, 2 hours post treatment in each treatment period
measure: SMH Recovery of Enamel Specimens Post 2 Hours of Treatment Exposure
timeFrame: Baseline, 2 hours post treatment in each treatment period
Locations:
city: Indianapolis
country: United States
facility: Indiana University School of Dentistry
state: Indiana
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: