Dentine Tubule Occlusion Assessment in a Modified in Situ Model

Dentin Sensitivity Clinical Trial

Official title:

Assessment of Dentine Tubule Occlusion in a Modified in Situ Model

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02768194
• Other study ID #: 205699
• Status: Completed
• Phase: N/A
• Start date: July 6, 2016
• Est. completion date: September 21, 2016

Study information

• Verified date: March 2018
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: September 21, 2016
• Est. primary completion date: September 1, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Dentin Sensitivity

Intervention

Device:
• Stannous fluoride
Dentifrice containing 0.454% stannous fluoride

Other:
• Sodium monofluorophosphate
Dentifrice containing 0.76% sodium monofluorophosphate
• Mineral water
Commercially available mineral water

Locations

Country	Name	City	State
United Kingdom	GSK Investigational Site	Bristol

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline and Day 8
Secondary	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	Baseline, Day 1, 4, and 10