N/A N=184 Randomized Triple-blind Prevention

Clinical Performance of Two Fissure Sealants

Caries Pit and Fissure Limited to Enamel

Bottom Line

View on ClinicalTrials.gov: NCT03470129 ↗

Enrolled (actual)

184

Serious AEs

0.0%

Results posted

Apr 2025

Primary outcome: Primary: Retention of the Sealant — 0; 0; 164; 164 Sealants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: fissure sealing (Device)
Age: Pediatric, Adult · 5+ yrs
Sex: All
Sponsor: Ivoclar Vivadent AG
Primary completion: Mar 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Retention of the Sealant	0; 0; 164; 164; 0; 0	—
PRIMARY Retention of Sealant	0; 0; 84; 81; 29; 26	—
PRIMARY Retention of Sealant	0; 0; 84; 81; 29; 26	—
PRIMARY Retention of Sealant	0; 0; 84; 81; 29; 26	—
SECONDARY Caries	123; 120; 11; 11; 0; 0	—
SECONDARY Caries	123; 120; 11; 11; 0; 0	—
SECONDARY Caries	123; 120; 11; 11; 0; 0	—
SECONDARY Caries	123; 120; 11; 11; 0; 0	—

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

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03470129). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.