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NCT Number: NCT07622043

Effectiveness of Two Different Desensitizing Dental Varnishes

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.

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Key information

Conditions

Dentin Hypersensitivity Dentin Desensitizing Agents Dentin Sensitivity Stomatognathic Diseases Tooth Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Informed Consent signed by the subject
  • Age: 18-65 years
  • Hypersensitivity assessment scale ≥ Grade 2 in
  • two non-neighboring teeth in different quadrants
  • The affected teeth are/have: vital, caries-free, received no restorations within the last month
  • No change in medication anticipated over the next 3 months (e.g. due to upcoming surgery etc.)

Exclusion criteria

  • 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
  • Enrolment of employees of the dental clinic of Ivoclar Vivadent AG
  • Recent change in medication concerning Analgesics, NSAIDs, psychotropic drugs, other medications that may alter pain perception
  • Intake of analgesics prior to appointment
  • Professional desensitizing therapy in the last 3 months
  • Bleaching procedures in the last 4 weeks
  • Confounding dental conditions at test sites: defective or extensive restorations, abutment teeth for prostheses, recent restorations, pulpitis/periapical pathology.
  • Current or recent use of desensitizing toothpastes or mouthrinses (i.e. products specifically marketed for the treatment of dentin hypersensitivity) within 4 weeks prior to enrolment

Treatment and study plan

Fluoride-containing varnish

Device

A fluoride-containing varnish is applied to a tooth that is hypersensitive.

Fluoride-free varnish

Device

A fluoride-free varnish is applied to a tooth that is hypersensitive.

Primary outcomes

  1. Reduction of dentin hypersensitivity

    Time frame: 1 week

    assessed by patient response to an air stimulus using a pain scale (grades 0-4, lower scores mean a better outcome)

Sponsors and collaborators

Lead sponsor

Ivoclar Vivadent AG

Industry

Registry information

Official study title

Effectiveness of Two Different Desensitizing Dental Varnishes: A Prospective, Randomized Split Mouth Clinical Investigation

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 2, 2026
Registry last updated
Jun 2, 2026

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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