Last updated: 11/07/2018 12:44:55

Dentine Tubule Occlusion Assessment in a Modified in situ Model

GSK study ID
205699
See study documents
Clinicaltrials.gov ID
NCT02768194
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Assessment of Dentine Tubule Occlusion in a Modified in situ Model
Trial description: This will be a single centre, single blind, randomized, three treatment, three period crossover design, modified, in situ, study in healthy participants. In this in situ model the tubule occlusion properties of dentifrices will be evaluated by comparing an experimental dentifrice formulation to a regular fluoride dentifrice and a negative control (mineral water) over a ten day period.
Primary purpose:
Basic Science
Trial design:
Crossover Assignment
Masking:
Single (Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:

Change from baseline in mean occlusion scores after 8 days treatment application

Timeframe: Baseline and Day 8

Secondary outcomes:

Change from baseline in mean occlusion scores after 1, 4, & 10 days treatment application

Timeframe: Baseline, Day 1, 4, and 10

Interventions:
  • Device: Stannous fluoride
  • Other: Sodium monofluorophosphate
  • Other: Mineral water
    • Enrollment:
    26
    Primary completion date:
    2016-21-09
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    https://doi.org/10.1016/j.jdent.2018.07.001
    Medical condition
    Dentin Sensitivity
    Product
    SKF46655, SKF46656
    Collaborators
    Not applicable
    Study date(s)
    July 2016 to September 2016
    Type
    Interventional
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 80 years
    Accepts healthy volunteers
    Yes
    • Demonstrates understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
    • Aged between 18 and 80 years
    • Women who are known to be pregnant or who are intending to become pregnant over the duration of the study.
    • Women who are breast-feeding
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Demonstrates understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
    • Aged between 18 and 80 years
    • Understands and is willing, able and likely to comply with all study procedures and restrictions.
    • Good general and mental health with, in the opinion of the investigator or medically qualified designee: No clinically significant and relevant abnormalities in medical history or upon oral examination, absence of any condition that would impact on the participant’s safety or well being or affect the individual’s ability to understand and follow procedures and requirements.
    • Be able to accommodate the lower bi-lateral buccal intra-oral appliances each fitted with four dentine samples
    Exclusion criteria:
    • Women who are known to be pregnant or who are intending to become pregnant over the duration of the study.
    • Women who are breast-feeding
    • Current or recurrent disease/dental pathology that in the opinion of the investigator could affect the study outcomes. Current susceptibility to acid regurgitation, any orthodontic appliances, restorations, bridgework or dentures that in the opinion of the investigator would interfere with the study outcomes, recurrent or regular aphthous ulcers, severe gingivitis, carious lesions and periodontal disease,signs of severe dental erosion, any condition or medication which in the opinion of the investigator is currently causing xerostomia, and individuals who require antibiotic prophylaxis for dental procedures
    • Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients
    • Participation in another study (clinical or cosmetic studies) or receipt of an investigational drug within 15 days of the screening visit, previous participation in this study.
    • Recent history (within the last year) of alcohol or other substance abuse
    • An employee of the sponsor or the study site or members of their immediate family. The site for this protocol is the Clinical Trials Unit in the Bristol Dental School and Hospital. Employees of the Bristol Dental School and Hospital not associated with the Clinical Trials Unit are eligible to participate
    • Any participant who, in the judgement of the investigator, should not participate in the study

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Bristol, United Kingdom, BS1 2LY
    Status
    Study Complete
    Contact us

    Study documents

    Statistical analysis plan
    Available language(s): English
    Download document(s)
    Clinical study report
    Available language(s): English
    Download document(s)
    Protocol
    Available language(s): English
    Download document(s)

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

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2016-21-09
    Actual study completion date
    2016-21-09

    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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