Clinical Performance of Two Fissure Sealants

Not Applicable

Completed

• Conditions: Caries Pit and Fissure Limited to Enamel
• Interventions: Device: fissure sealing

• 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

Study Timeline

• Study First Submitted: 2018-03-06
• Study First Submitted QC: 2018-03-12
• Study First Posted: 2018-03-19
• Study Start: 2018-09-01
• Primary Completion: 2022-03-14
• Study Completion: 2022-03-14
• Results First Submitted: 2024-03-26
• Status Verified: 2025-04
• Results First Submitted QC: 2025-04-07
• Last Update Submitted: 2025-04-07
• Results First Posted: 2025-04-08
• Last Update Posted: 2025-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Helioseal F Plus	fissure sealing	fissure sealing with the new product
Helioseal F	fissure sealing	fissure sealing with the conventional product

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)

Zahnarztpraxis Graeser; 🇨🇭 Wädenswil, Zürich, Switzerland

Prof. Jan Kühnisch; 🇩🇪 München, Bavaria, Germany