Clinical Trial to Compare the Efficacy of a Fluoride Gel and a Dental Bonding Agent in Treatment of Tooth Sensitivity
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.
1 other identifier
interventional
26
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2016
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 27, 2016
CompletedFirst Posted
Study publicly available on registry
September 29, 2016
CompletedStudy Start
First participant enrolled
October 26, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 4, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 4, 2017
CompletedMay 5, 2017
May 1, 2017
2 months
September 27, 2016
May 2, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Visual Analogue Scale
to measure pain/sensitivity perception
14 days
Study Arms (2)
Fluoride Varnish
EXPERIMENTALColgate Fluoride Varnish Suspension. 2.26% Sodium Fluoride.
SEDBA
ACTIVE COMPARATORSelf-etching Dentine Bonding Agent. Scotchbond Universal by 3M ESPE. Topical application followed by light curing for 20 seconds.
Interventions
Topical application to exposed dentine on one occasion.
Topical application to exposed dentine on one occasion followed by light-curing procedure.
Eligibility Criteria
You may qualify if:
- Aged 18-60.
- Exhibiting CDS elicited by the two test stimuli in relation at least one tooth.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Carfax Dental Practice
Horsham, West Sussex, RH12 1EB, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Claire Parkin, PhD
University of Kent
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 27, 2016
First Posted
September 29, 2016
Study Start
October 26, 2016
Primary Completion
January 4, 2017
Study Completion
January 4, 2017
Last Updated
May 5, 2017
Record last verified: 2017-05
Data Sharing
- IPD Sharing
- Will not share