K08.9
Conditions
Interventions
Group 1: Intervention group: varnish with 22,600 ppm sodium fluoride
Group 2: Control group: placebo group without sodium fluoride
Sponsors
Martin-Luther-Universität-Halle-Wittenberg, universitätspoliklinik für Zahnerhaltungkunde und Parodontologie
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: - signed declaration of consent - the test persons must have at least 2 sensitive teeth (sensitive cervival dentin) fulfilling the following inclusion criteria: - Localization anterior to the molars - cervical erosions/abrasions or gingival recessions - significant irritation response with a value of 2 to 3 (based on the Schiff Cold Air Sensitivity Scale) to a one-second air stimulus on the cervical dentin - No periodontal diseases or their treatments in the last 12 months before baseline - Location outside of quadrants in which periodontal diseases exist or existed and whose treatments in the last 12 months took place - chewing gum must be avoided 8 hours before each study visit - Subjects must be in good general health with no known allergies to the study products. - the availability or accessibility of the patient must be guaranteed over the six-month study period
Exclusion criteria
Exclusion criteria: - serious and chronic diseases, allergies to ingredients of the test products test products - periodontal diseases or their treatment (including surgery) within the last twelve months on study teeth - Teeth with hypersensitivity according to other etiologies, such as - Teeth with deep, insufficient restorations - Teeth with advanced erosion - Teeth that are included in a prosthetic restoration - Single crowns - Teeth with suspected pulpitis - Teeth with orthodontic multi-band appliances - Teeth with large carious lesions or enamel cracks - Teeth that are exposed to abnormal occlusal loads - Teeth with a degree of looseness greater than one - Patients taking antiepileptic drugs, antihistamines, antidepressants, sedatives, tranquilizers, anti-inflammatory drugs or daily painkillers frequently - Use of desensitizing preparations during the last 3 months, including professional application and use of highly concentrated fluorides - current participation in other clinical studies or desensitizing Dentifrice studies in the last 12 months - Pregnant or breastfeeding mothers - ulcerating gums and oral mucosa inflammation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The aim of this study is to investigate the efficacy of Profluorid Varnish in patients with existing dentinal hypersensitivity in at least two teeth anterior to the molars in comparison with a placebo product over a period of six months and to reduce their symptoms. The primary parameters are the pain sensation to an air stimulus (Schiff score) and to a mechanical stimulus, represented by a Visual Analog Scale. These primary parameters are recorded at baseline and at each follow-up examination. | — |
Countries
Germany
Contacts
Public ContactChristian Gernhardt
Martin-Luther-Universität-Halle-Wittenberg, universitätspoliklinik für Zahnerhaltungkunde und Parodontologie
Outcome results
None listed