Clinical Performance of Two Fissure Sealants

NCT03470129 | Completed Results

• 1 other identifier: Helioseal F Plus
• Study Type: interventional
• Target: 92
• Locations: 2 countries
• Sites: 2

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

Conditions

Caries Pit and Fissure Limited to Enamel

Outcome Measures

Primary Outcomes (4)

• Retention of the Sealant

  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

  7-28 days

• Retention of Sealant

  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

  12 months

• Retention of Sealant

  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

  24 months

• Retention of Sealant

  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

  36 months

Secondary Outcomes (4)

• Caries

  7-28 days

• Caries

  12 months

• Caries

  24 months

• Caries

  36 months

Study Arms (2)

Helioseal F

ACTIVE COMPARATOR

fissure sealing with the conventional product

Device: fissure sealing

Helioseal F Plus

EXPERIMENTAL

fissure sealing with the new product

Device: fissure sealing

Interventions

fissure sealing DEVICE

sealing of occlusal fissures with either the conventional sealant, Helioseal F, or the new sealant, Helioseal F Plus, which provides an additional feature and an improved formulation

Helioseal F; Helioseal F Plus

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ivoclar Vivadent AG: lead

Study Sites (2)

Prof. Jan Kühnisch

München, Bavaria, 80336, Germany

Location

Zahnarztpraxis Graeser

Wädenswil, Canton of Zurich, 8820, Switzerland

Location

Results Point of Contact

• Title: Team Leader Study Management
• Organization: Ivoclar Vivadent AG

patrizia.elkuch-hoch@ivoclar.com

+4232353780

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2018
• First Posted: March 19, 2018
• Study Start: September 1, 2018
• Primary Completion: March 14, 2022
• Study Completion: March 14, 2022
• Last Updated: April 8, 2025
• Results First Posted: April 8, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1); DE (1)