Back to resultsClinical Trial to Compare the Efficacy of a Fluoride Gel and a Dental Bonding Agent in Treatment of Tooth Sensitivity
Primary Purpose
Dentin Sensitivity
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Colgate Fluoride Varnish Suspension. 2.26% Sodium Fluoride.
Self-etching Dentine Bonding Agent
Sponsored by
About this trial
This is an interventional treatment trial for Dentin Sensitivity
Eligibility Criteria
Inclusion Criteria:
- Aged 18-60.
- Exhibiting CDS elicited by the two test stimuli in relation at least one tooth.
Exclusion Criteria:
- Patients who have undergone comprehensive periodontal treatment in the past 3 months.
- Patients under the age of 18 or unable to provide valid consent.
- Teeth that have visible fracture lines, caries, crowns or have been endodontically treated.
- Patients taking analgesic medication for any systemic conditions.
Sites / Locations
- Carfax Dental Practice
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Fluoride Varnish
SEDBA
Arm Description
Colgate Fluoride Varnish Suspension. 2.26% Sodium Fluoride.
Self-etching Dentine Bonding Agent. Scotchbond Universal by 3M ESPE. Topical application followed by light curing for 20 seconds.
Outcomes
Primary Outcome Measures
Visual Analogue Scale
to measure pain/sensitivity perception
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02919202
Brief Title
Clinical Trial to Compare the Efficacy of a Fluoride Gel and a Dental Bonding Agent in Treatment of Tooth Sensitivity
Official Title
A Randomised Controlled Trial Investigating a Comparison of Fluoride Varnish vs Self-Etching Dentine Bonding Agent in the Reduction of Cervical Dentine Sensitivity in Patients Attending a General Dental Practice in West Sussex, UK.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
October 26, 2016 (Actual)
Primary Completion Date
January 4, 2017 (Actual)
Study Completion Date
January 4, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Kent
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study compares the efficacy of two dental interventions in the treatment of cervical dentine sensitivity. The participants will be selected from adult dental patients registered at a general dental practice in West Sussex, UK. The participants will be split into 2 groups. One group will receive the intervention of topical fluoride varnish application while the other group will receive a topical application of self-etching dentine bonding agent.
Detailed Description
Topical Fluoride Varnish(TFV) and Self-Etching Dentine Bonding Agent (SEDBA) are both routinely used in dentistry in the management of cervical dentine sensitivity(CDS). Both interventions are topically applied and well tolerated by patients. The interventions differ in mechanism of action. TFV releases fluoride which is incorporated into the organic matrix of dentine making the dentine tubules less conductive. Dentinal tubules form the key conduit between stimulus and pain perception in the tooth. SEDBA differs in that it penetrates and occludes the tubules. It is light cured for an almost instant set time.
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
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fluoride Varnish
Arm Type
Experimental
Arm Description
Colgate Fluoride Varnish Suspension. 2.26% Sodium Fluoride.
Arm Title
SEDBA
Arm Type
Active Comparator
Arm Description
Self-etching Dentine Bonding Agent. Scotchbond Universal by 3M ESPE. Topical application followed by light curing for 20 seconds.
Intervention Type
Procedure
Intervention Name(s)
Colgate Fluoride Varnish Suspension. 2.26% Sodium Fluoride.
Other Intervention Name(s)
Duraphat Varnish
Intervention Description
Topical application to exposed dentine on one occasion.
Intervention Type
Procedure
Intervention Name(s)
Self-etching Dentine Bonding Agent
Other Intervention Name(s)
Scotchbond Universal
Intervention Description
Topical application to exposed dentine on one occasion followed by light-curing procedure.
Primary Outcome Measure Information:
Title
Visual Analogue Scale
Description
to measure pain/sensitivity perception
Time Frame
14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Aged 18-60.
Exhibiting CDS elicited by the two test stimuli in relation at least one tooth.
Exclusion Criteria:
Patients who have undergone comprehensive periodontal treatment in the past 3 months.
Patients under the age of 18 or unable to provide valid consent.
Teeth that have visible fracture lines, caries, crowns or have been endodontically treated.
Patients taking analgesic medication for any systemic conditions.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claire Parkin, PhD
Organizational Affiliation
University of Kent
Official's Role
Principal Investigator
Facility Information:
Facility Name
Carfax Dental Practice
City
Horsham
State/Province
West Sussex
ZIP/Postal Code
RH12 1EB
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Trial to Compare the Efficacy of a Fluoride Gel and a Dental Bonding Agent in Treatment of Tooth Sensitivity
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