Dentin Desensitizing Agents, Dentin Hypersensitivity
Conditions
Brief summary
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
DEVICEFluoride-containing varnish
A fluoride-containing varnish is applied to a tooth that is hypersensitive.
DEVICEFluoride-free varnish
A fluoride-free varnish is applied to a tooth that is hypersensitive.
Sponsors
Ivoclar Vivadent AG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
split-mouth design: 2 hypersensitive teeth are treated per participant (test and control treatment in the same patient)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of dentin hypersensitivity | 1 week | assessed by patient response to an air stimulus using a pain scale (grades 0-4, lower scores mean a better outcome) |
Countries
Liechtenstein
Outcome results
None listed