Clinical Performance of Two Fissure Sealants

Ivoclar Vivadent

Status: Completed

Conditions: Caries Pit and Fissure Limited to Enamel

Treatments: Device: fissure sealing

Study type: Interventional

Funder types: Industry

Identifiers

NCT03470129

Helioseal F Plus

Details and patient eligibility

About

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

Enrollment: 92 patients

Sex: All

Ages: 5 to 18 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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92 participants in 2 patient groups

Helioseal F

Active Comparator group

Description:

fissure sealing with the conventional product

Treatment:

Device: fissure sealing

Helioseal F Plus

Experimental group

Description:

fissure sealing with the new product

Treatment:

Device: fissure sealing