Effectiveness of Two Different Desensitizing Dental Varnishes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Fluoride-containing varnish, Fluoride-free varnish.
- Who it may be relevant to
- Registry conditions: Dentin Hypersensitivity, Dentin Desensitizing Agents. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Liechtenstein
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effectiveness of Two Different Desensitizing Dental Varnishes: A Prospective, Randomized Split Mouth Clinical Investigation
Overview
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.
Interventions
- Device Fluoride-containing varnish
A fluoride-containing varnish is applied to a tooth that is hypersensitive. - Device Fluoride-free varnish
A fluoride-free varnish is applied to a tooth that is hypersensitive.
Primary outcome measures
- Reduction of dentin hypersensitivity [Time frame: 1 week]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Liechtenstein · 1 center
- Internal Clinic Ivoclar Vivadent AG — Schaan
Identifiers
NCT: NCT07622043 · OTCS 524967700