Back to resultsDentine Tubule Occlusion Assessment in a Modified in Situ Model
Primary Purpose
Dentin Sensitivity
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Stannous fluoride
Sodium monofluorophosphate
Mineral water
Sponsored by
About this trial
This is an interventional basic science trial for Dentin Sensitivity
Eligibility 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
Sites / Locations
- GSK Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Other
Arm Label
Test Product (0.454% stannous fluoride)
Reference Product (0.76% sodium monofluorophosphate)
Negative Control (Mineral water)
Arm Description
Participants will use dentifrice containing 0.454% stannous fluoride. Appliances brushed ex situ in 1:3 slurry of freshly prepared dentifrice twice daily will be then returned to the participant's mouth. Each appliance will be brushed for 1 minute (2 minutes total for both of the participant's appliances) using an electric toothbrush in a 1:3 slurry of assigned dentifrice. Appliances will be returned to the participant's mouth and the participant will rinse with 10 mls of mineral water for 5 seconds.
Participants will use dentifrice containing 0.76% sodium monofluorophosphate. Appliances brushed ex situ in 1:3 slurry of freshly prepared dentifrice twice daily will be then returned to the participant's mouth. Each appliance will be brushed for 1 minute (2 minutes total for both of the participant's appliances) using an electric toothbrush in a 1:3 slurry of assigned dentifrice. Appliances will be returned to the participant's mouth and the participant will rinse with 10 mls of mineral water for 5 seconds.
Participants will use commercially available mineral water. Appliances brushed ex situ in mineral water twice daily will be then returned to the participant's mouth. Each appliance will be brushed for 1 minute (2 minutes total for both of the participant's appliances) using an electric toothbrush in mineral water. Appliances will be returned to the participant's mouth and the participant will rinse with 10 mls of mineral water for 5 seconds.
Outcomes
Primary Outcome Measures
Change From Baseline in Mean Occlusion Scores After 8 Days Treatment Application
Change from baseline (pre-dose) in the mean occlusion classification score was calculated. The degree of occlusion was measured using the following classification grades; 0 Not Evaluable, 1 Occluded, 2 Mostly Occluded, 3 Equally Occluded/Unoccluded, 4 Mostly Unoccluded and 5 Unoccluded
Secondary Outcome Measures
Change From Baseline in Mean Occlusion Scores After 1, 4, & 10 Days Treatment Application
Change from baseline (pre-dose) in the mean occlusion classification score was calculated. The degree of occlusion was measured using the following classification grades; 0 Not Evaluable, 1 Occluded, 2 Mostly Occluded, 3 Equally Occluded/Unoccluded, 4 Mostly Unoccluded and 5 Unoccluded
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02768194
Brief Title
Dentine Tubule Occlusion Assessment in a Modified in Situ Model
Official Title
Assessment of Dentine Tubule Occlusion in a Modified in Situ Model
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
July 6, 2016 (Actual)
Primary Completion Date
September 1, 2016 (Actual)
Study Completion Date
September 21, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
5. Study Description
Brief Summary
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.
Detailed Description
This modified in situ model study will evaluate the mode-of-action of an experimental dentifrice containing stannous fluoride to occlude tubules compared to a regular fluoride dentifrice and a negative control (mineral water). The study treatments will be administered for a total of 10 days, with participants wearing two appliances in their mouth that will hold samples of dentine. The dentine samples will be examined after 1, 4, 8 and 10 days of treatment using scanning electron microscopy (SEM) and the resulting images graded for the amount of occlusion. In addition, the robustness of any occlusion generated by the treatments will be tested by exposing the dentine samples to an acid challenge (orange juice) after 9 and 10 days treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dentin Sensitivity
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Test Product (0.454% stannous fluoride)
Arm Type
Experimental
Arm Description
Participants will use dentifrice containing 0.454% stannous fluoride. Appliances brushed ex situ in 1:3 slurry of freshly prepared dentifrice twice daily will be then returned to the participant's mouth. Each appliance will be brushed for 1 minute (2 minutes total for both of the participant's appliances) using an electric toothbrush in a 1:3 slurry of assigned dentifrice. Appliances will be returned to the participant's mouth and the participant will rinse with 10 mls of mineral water for 5 seconds.
Arm Title
Reference Product (0.76% sodium monofluorophosphate)
Arm Type
Active Comparator
Arm Description
Participants will use dentifrice containing 0.76% sodium monofluorophosphate. Appliances brushed ex situ in 1:3 slurry of freshly prepared dentifrice twice daily will be then returned to the participant's mouth. Each appliance will be brushed for 1 minute (2 minutes total for both of the participant's appliances) using an electric toothbrush in a 1:3 slurry of assigned dentifrice. Appliances will be returned to the participant's mouth and the participant will rinse with 10 mls of mineral water for 5 seconds.
Arm Title
Negative Control (Mineral water)
Arm Type
Other
Arm Description
Participants will use commercially available mineral water. Appliances brushed ex situ in mineral water twice daily will be then returned to the participant's mouth. Each appliance will be brushed for 1 minute (2 minutes total for both of the participant's appliances) using an electric toothbrush in mineral water. Appliances will be returned to the participant's mouth and the participant will rinse with 10 mls of mineral water for 5 seconds.
Intervention Type
Device
Intervention Name(s)
Stannous fluoride
Intervention Description
Dentifrice containing 0.454% stannous fluoride
Intervention Type
Other
Intervention Name(s)
Sodium monofluorophosphate
Intervention Description
Dentifrice containing 0.76% sodium monofluorophosphate
Intervention Type
Other
Intervention Name(s)
Mineral water
Intervention Description
Commercially available mineral water
Primary Outcome Measure Information:
Title
Change From Baseline in Mean Occlusion Scores After 8 Days Treatment Application
Description
Change from baseline (pre-dose) in the mean occlusion classification score was calculated. The degree of occlusion was measured using the following classification grades; 0 Not Evaluable, 1 Occluded, 2 Mostly Occluded, 3 Equally Occluded/Unoccluded, 4 Mostly Unoccluded and 5 Unoccluded
Time Frame
Baseline and Day 8
Secondary Outcome Measure Information:
Title
Change From Baseline in Mean Occlusion Scores After 1, 4, & 10 Days Treatment Application
Description
Change from baseline (pre-dose) in the mean occlusion classification score was calculated. The degree of occlusion was measured using the following classification grades; 0 Not Evaluable, 1 Occluded, 2 Mostly Occluded, 3 Equally Occluded/Unoccluded, 4 Mostly Unoccluded and 5 Unoccluded
Time Frame
Baseline, Day 1, 4, and 10
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Bristol
ZIP/Postal Code
BS1 2LY
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
29981778
Citation
West NX, Seong J, Hellin N, Macdonald EL, Jones SB, Creeth JE. Assessment of tubule occlusion properties of an experimental stannous fluoride toothpaste: A randomised clinical in situ study. J Dent. 2018 Sep;76:125-131. doi: 10.1016/j.jdent.2018.07.001. Epub 2018 Jul 5.
Results Reference
derived
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Dentine Tubule Occlusion Assessment in a Modified in Situ Model
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