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NCT02919202 Clinical Trial

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

Dentin Sensitivity Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02919202
Other study ID # ResGov 354
Secondary ID
Status Completed
Phase N/A
First received September 27, 2016
Last updated May 2, 2017
Start date October 26, 2016
Est. completion date January 4, 2017

Study information
Verified date May 2017
Source University of Kent
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 26
Est. completion date January 4, 2017
Est. primary completion date January 4, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Procedure:
• Colgate Fluoride Varnish Suspension. 2.26% Sodium Fluoride.
Topical application to exposed dentine on one occasion.
• Self-etching Dentine Bonding Agent
Topical application to exposed dentine on one occasion followed by light-curing procedure.

Locations
Country Name City State
United Kingdom Carfax Dental Practice Horsham West Sussex

Sponsors (1)
Lead Sponsor Collaborator
University of Kent

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Visual Analogue Scale to measure pain/sensitivity perception 14 days
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Not yet recruiting NCT04485299 - Clinical Assessment of Bifluorid 10 vs Varnish Fluoride on The Exposed Hypersensitive Cervical Dentin in Adult Patient Phase 2/Phase 3
Completed NCT02931734 - Assessment of Different Protocols for Cervical Dentin Hypersensitivity Treatment N/A
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Completed NCT02612064 - The Efficacy of an Occluding Dentifrice in Providing Relief From Dentinal Hypersensitivity N/A
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Completed NCT02128633 - Effectiveness of a Homecare Dentin Hypersensitivity Gel Phase 2/Phase 3
Completed NCT03310268 - A Clinical Study to Evaluate a Stannous Fluoride Toothpaste for the Relief of Dentinal Hypersensitivity N/A
Completed NCT05750745 - A Clinical Study to Evaluate the Efficacy of a Stannous Fluoride Toothpaste for the Relief of Dentine Hypersensitivity in a Chinese Population N/A
Completed NCT02752958 - Impact of Long Term Management of Dentine Hypersensitivity (DH) With a Daily Use Anti-sensitivity Toothpaste on the Quality of Life Related to Oral Health N/A
Completed NCT02918617 - Clinical Efficacy in Relieving Dentin Hypersensitivity of Nanohydroxyapatite-Containing Toothpastes and Cream Phase 2