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Completed

NCT Number: NCT02919202

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

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.

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Key information

Conditions

Dentin Sensitivity Stomatognathic Diseases Tooth Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Carfax Dental Practice

Horsham, West Sussex, RH12 1EB, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Colgate Fluoride Varnish Suspension. 2.26% Sodium Fluoride.

Procedure

Topical application to exposed dentine on one occasion.

Other names: Duraphat Varnish

Self-etching Dentine Bonding Agent

Procedure

Topical application to exposed dentine on one occasion followed by light-curing procedure.

Other names: Scotchbond Universal

Primary outcomes

  1. Visual Analogue Scale

    Time frame: 14 days

    to measure pain/sensitivity perception

Sponsors and collaborators

Lead sponsor

University of Kent

Other

Registry information

Official study 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.

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Sep 29, 2016
Registry last updated
May 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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