Last updated: 11/04/2018 13:50:30

Evaluation of efficacy of experimental gel to foam dentifrices in dental erosion

GSK study ID
Z6961385
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A Placebo Controlled Study to Evaluate the Effectiveness of Experimental Foaming Gel Toothpastes Using an In-situ Erosion Remineralization Model
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Single (Investigator)
Allocation:
Randomized
Primary outcomes:

Relative erosion resistance (RER) of enamel specimens post 4 hours of treatment exposure

Timeframe: Baseline, 4 hours post treatment in each treatment period

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:
Not applicable
Interventions:
Drug: Sodium Fluoride
Drug: Potassium nitrate
Enrollment:
56
Observational study model:
Not applicable
Primary completion date:
2012-29-02
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Dental erosion
Product
Not applicable
Collaborators
Not applicable
Study date(s)
November 2011 to February 2012
Type
Interventional
Phase
Not applicable

Participation criteria

Sex
Female & Male
Age
18 - 65 years
Accepts healthy volunteers
Yes
  • General and Oral Health: Good general health with (in the opinion of the investigator) no clinically OST and OHT examinations.
  • Oral Requirements:
  • Oral Health:
  • – Current active caries or periodontal disease that may compromise the study or the health of the subjects.

Trial location(s)

Location
Status
Contact us
Contact us
Location
Indiana University School of Dentistry
Indianapolis, IN, United States, 46202
Status
Study Complete

Study documents

Scientific result summary
Available language(s): English

If you wish to request for full study report, please contact - [email protected]

Results overview

Results posted on ClinicalTrials.gov

Recruitment status
Completed
Actual primary completion date
2012-29-02
Actual study completion date
2012-29-02

Plain language summaries

Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

Additional information about the trial

Additional information
Not applicable
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