Clinical Trial to Compare the Efficacy of a Fluoride Gel and a Dental Bonding Agent in Treatment of Tooth Sensitivity

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Dentin Sensitivity

Intervention / Treatment
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* Procedure: Colgate Fluoride Varnish Suspension. 2.26% Sodium Fluoride.
* Procedure: Self-etching Dentine Bonding Agent


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fluoride Varnish<br>Colgate Fluoride Varnish Suspension. 2.26% Sodium Fluoride. | Procedure: Colgate Fluoride Varnish Suspension. 2.26% Sodium Fluoride.<br>* Topical application to exposed dentine on one occasion.<br>* Other names: Duraphat Varnish;|
| Active Comparator: SEDBA<br>Self-etching Dentine Bonding Agent. Scotchbond Universal by 3M ESPE. Topical application followed by light curing for 20 seconds. | Procedure: Self-etching Dentine Bonding Agent<br>* Topical application to exposed dentine on one occasion followed by light-curing procedure.<br>* Other names: Scotchbond Universal;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Scale | to measure pain/sensitivity perception | 14 days |