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

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ClinicalTrials.gov Identifier: NCT02919202
Recruitment Status : Completed
First Posted : September 29, 2016
Last Update Posted : May 5, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Dentin Sensitivity Procedure: Colgate Fluoride Varnish Suspension. 2.26% Sodium Fluoride. Procedure: Self-etching Dentine Bonding Agent Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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.
Actual Study Start Date : October 26, 2016
Actual Primary Completion Date : January 4, 2017
Actual Study Completion Date : January 4, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Arm Intervention/treatment
Experimental: Fluoride Varnish
Colgate Fluoride Varnish Suspension. 2.26% Sodium Fluoride.
Procedure: Colgate Fluoride Varnish Suspension. 2.26% Sodium Fluoride.
Topical application to exposed dentine on one occasion.
Other Name: Duraphat Varnish

Active Comparator: SEDBA
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
Topical application to exposed dentine on one occasion followed by light-curing procedure.
Other Name: Scotchbond Universal




Primary Outcome Measures :
  1. Visual Analogue Scale [ Time Frame: 14 days ]
    to measure pain/sensitivity perception



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02919202


Locations
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United Kingdom
Carfax Dental Practice
Horsham, West Sussex, United Kingdom, RH12 1EB
Sponsors and Collaborators
University of Kent
Investigators
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Principal Investigator: Claire Parkin, PhD University of Kent

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Responsible Party: University of Kent
ClinicalTrials.gov Identifier: NCT02919202     History of Changes
Other Study ID Numbers: ResGov 354
First Posted: September 29, 2016    Key Record Dates
Last Update Posted: May 5, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Listerine
Fluorides
Sodium Fluoride
Fluorides, Topical
Dentin Sensitivity
Hypersensitivity
Immune System Diseases
Tooth Diseases
Stomatognathic Diseases
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Anti-Infective Agents, Local
Anti-Infective Agents