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Clinical Trials/NCT03470129
NCT03470129
Completed
Not Applicable

Klinische Bewährung Zweier Fissurenversiegler

Ivoclar Vivadent AG2 sites in 2 countries92 target enrollmentSeptember 1, 2018
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ConditionsCaries Pit and Fissure Limited to Enamel

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Caries Pit and Fissure Limited to Enamel
Sponsor
Ivoclar Vivadent AG
Enrollment
92
Locations
2
Primary Endpoint
Retention of the Sealant
Status
Completed
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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

Registry
clinicaltrials.gov
Start Date
September 1, 2018
End Date
March 14, 2022
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •participants
  • •ASA Status 1
  • •all dentinal lesions are restored
  • •consent of parents and patient
  • •instruction and demonstration of oral hygiene
  • •first and second molars of the permanent dentition
  • •healthy teeth without caries
  • •molars with primary lesions

Exclusion Criteria

  • •participants
  • •no consent
  • •allergies to methacrylates or other ingredients of dental products
  • •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

Outcomes

Primary Outcomes

Retention of the Sealant

Time Frame: 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

Time Frame: 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 Outcomes

  • Caries(36 months)

Study Sites (2)

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