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

Not Applicable

Completed

• Conditions: Dentin Sensitivity
• Interventions: Procedure: Self-etching Dentine Bonding Agent; Procedure: Colgate Fluoride Varnish Suspension. 2.26% Sodium Fluoride.

• Registration Number: NCT02919202
• Lead Sponsor: University of Kent

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.

Study Timeline

• Study First Submitted: 2016-09-27
• Study First Submitted QC: 2016-09-27
• Study First Posted: 2016-09-29
• Study Start: 2016-10-26
• Primary Completion: 2017-01-04
• Study Completion: 2017-01-04
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-02
• Last Update Posted: 2017-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SEDBA	Self-etching Dentine Bonding Agent	Self-etching Dentine Bonding Agent. Scotchbond Universal by 3M ESPE. Topical application followed by light curing for 20 seconds.
Fluoride Varnish	Colgate Fluoride Varnish Suspension. 2.26% Sodium Fluoride.	Colgate Fluoride Varnish Suspension. 2.26% Sodium Fluoride.

Primary Outcome Measures

Name	Time	Method
Visual Analogue Scale	14 days	to measure pain/sensitivity perception

Trial Locations

Locations (1)

Carfax Dental Practice; 🇬🇧 Horsham, West Sussex, United Kingdom