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

NCT ID: NCT02919202

Last Updated: 2017-05-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-26

Study Completion Date

2017-01-04

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.

Conditions

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Dentin Sensitivity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Fluoride Varnish

Colgate Fluoride Varnish Suspension. 2.26% Sodium Fluoride.

Group Type EXPERIMENTAL

Colgate Fluoride Varnish Suspension. 2.26% Sodium Fluoride.

Intervention Type PROCEDURE

Topical application to exposed dentine on one occasion.

SEDBA

Self-etching Dentine Bonding Agent. Scotchbond Universal by 3M ESPE. Topical application followed by light curing for 20 seconds.

Group Type ACTIVE_COMPARATOR

Self-etching Dentine Bonding Agent

Intervention Type PROCEDURE

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

Interventions

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Colgate Fluoride Varnish Suspension. 2.26% Sodium Fluoride.

Topical application to exposed dentine on one occasion.

Intervention Type PROCEDURE

Self-etching Dentine Bonding Agent

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

Intervention Type PROCEDURE

Other Intervention Names

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Duraphat Varnish Scotchbond Universal

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Kent

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Claire Parkin, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Kent

Locations

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Carfax Dental Practice

Horsham, West Sussex, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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ResGov 354

Identifier Type: -

Identifier Source: org_study_id

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