Clinical Performance of Two Fissure Sealants

Klinische Bewährung Zweier Fissurenversiegler

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

Study Overview

• Status: Completed
• Conditions: Caries Pit and Fissure Limited to Enamel
• Intervention / Treatment: Device: fissure sealing

• Study Type: Interventional
• Enrollment (Actual): 92
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Bavaria
    • München, Bavaria, Germany, 80336
      • Prof. Jan Kühnisch
• Switzerland
  • Zürich
    • Wädenswil, Zürich, Switzerland, 8820
      • Zahnarztpraxis Graeser

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Helioseal F; fissure sealing with the conventional product	Device: fissure sealing; 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
Experimental: Helioseal F Plus; fissure sealing with the new product	Device: fissure sealing; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Caries	evaluation of the presence of carious lesions according to UniViSS 2.0	7-28 days
Caries	evaluation of the presence of carious lesions according to UniViSS 2.0	12 months
Caries	evaluation of the presence of carious lesions according to UniViSS 2.0	24 months
Caries	evaluation of the presence of carious lesions according to UniViSS 2.0	36 months

Collaborators and Investigators

• Sponsor: Ivoclar Vivadent AG

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2018
• Primary Completion (Actual): March 14, 2022
• Study Completion (Actual): March 14, 2022

Study Registration Dates

• First Submitted: March 6, 2018
• First Submitted That Met QC Criteria: March 12, 2018
• First Posted (Actual): March 19, 2018

Study Record Updates

• Last Update Posted (Actual): April 8, 2025
• Last Update Submitted That Met QC Criteria: April 7, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: Helioseal F Plus

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No