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

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.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02919202
Enrollment
26
Registered
2016-09-29
Start date
2016-10-26
Completion date
2017-01-04
Last updated
2017-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dentin Sensitivity

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.

Interventions

PROCEDUREColgate Fluoride Varnish Suspension. 2.26% Sodium Fluoride.

Topical application to exposed dentine on one occasion.

PROCEDURESelf-etching Dentine Bonding Agent

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

Sponsors

University of Kent
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Visual Analogue Scale14 daysto measure pain/sensitivity perception

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026