Last updated: 11/07/2018 12:44:55
Dentine Tubule Occlusion Assessment in a Modified in situ Model
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
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
Observational study model:
Not applicable
Primary completion date:
2016-21-09
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)
Study documents
Statistical analysis plan
Available language(s): English
Clinical study report
Available language(s): English
Protocol
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
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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