Clinical Performance of Two Fissure Sealants
- Conditions
- Caries Pit and Fissure Limited to Enamel
- Registration Number
- NCT03470129
- Lead Sponsor
- Ivoclar Vivadent AG
- Brief Summary
Comparison of the retention of a new fissure sealant (Helioseal F Plus) and a fissure sealant that has been on the market for years in children
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 92
participants
- ASA Status 1
- all dentinal lesions are restored
- consent of parents and patient
- instruction and demonstration of oral hygiene
teeth:
- first and second molars of the permanent dentition
- healthy teeth without caries
- molars with primary lesions
participants
- no consent
- allergies to methacrylates or other ingredients of dental products
teeth:
- molars with occlusal cavities (UniViSS score occlusal > M)
- Molars with untreated dentinal lesions
- premolars, incisors, deciduous teeth
- teeth with huge occlusal restorations
- hypomineralized teeth or other defects
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Retention of the Sealant 7-28 days grade of retention is evaluated as 0 - no fissure sealant left/present 1 complete retention 2 minimal loss of sealant (max one third) 3: central retention of the sealant, 4: almost complete loss of the sealant - less than one third is left
Retention of Sealant 36 months grade of retention is evaluated as 0 - no fissure sealant left/present 1 complete retention 2 minimal loss of sealant (max one third) 3: central retention of the sealant, 4: almost complete loss of the sealant - less than one third is left
- Secondary Outcome Measures
Name Time Method Caries 36 months evaluation of the presence of carious lesions according to UniViSS 2.0
Trial Locations
- Locations (2)
Prof. Jan Kühnisch
🇩🇪München, Bavaria, Germany
Zahnarztpraxis Graeser
🇨🇭Wädenswil, Zürich, Switzerland
Prof. Jan Kühnisch🇩🇪München, Bavaria, Germany