Effectiveness of Two Different Desensitizing Dental Varnishes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorIvoclar Vivadent AG
About this trial
Dental varnishes are commonly used to relieve dentin hypersensitivity by forming a protective film that occludes dentinal tubules and reduces fluid flow. This clinical investigation aims to compare the desensitizing effect of a fluoride containing varnish with a fluoride free placebo varnish. Primary and secondary objectives include evaluating short and long term reductions in dentinal hypersensitivity, assessing patient reported outcomes and daily experiences, and monitoring the varnish's tolerability and safety.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Informed Consent signed by the subject
Age: 18-65 years
Hypersensitivity assessment scale ≥ Grade 2 in
two non-neighboring teeth in different quadrants
Disqualifiers
Contraindications and limitations of the MD as described in the instructions for use.
Known hypersensitivity or allergy to the device material (especially acrylates, mint flavouring)
Pregnant or other vulnerable subjects
Participants with severe systemic disease
Trial design
Design model
Parallel
Treatments tested in this trial
Fluoride-containing varnish
DeviceA fluoride-containing varnish is applied to a tooth that is hypersensitive.
Fluoride-free varnish
DeviceA fluoride-free varnish is applied to a tooth that is hypersensitive.
Treatment groups
66 Participants
are divided into 2 treatment groupsGroup A: Fluoride-containing varnishExperimental treatment 1 intervention
Group B: Fluoride-free varnishPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change of dentin hypersensitivity
assessed by patient response to an air stimulus using a pain scale (grades 0-4, lower scores mean a better outcome)
Time frame
1 weekSponsors and contacts
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Source ClinicalTrials.gov