Klinische Bewährung Zweier Fissurenversiegler
Phase: NA
Conditions: Caries Pit and Fissure Limited to Enamel
Sponsor: Ivoclar Vivadent AG

Clinical trial protocol for two fissure sealants  
 
 
 
 
 
Test plan 
Clinical trial of two fissure sealants - 
 
 
 
 
 
 
 
 
 
 
Version 3.0 
 
 
 
 
 
 
 
 
 
 
 
September 01, 2021 

Clinical trial protocol for two fissure sealants  
 
 
 
Synopsis 
 
Title: 
Clinical trial of two fissure sealants 
Testing institute: 
1. Polyclinic for Conservative Dentistry and Periodontology, LMU 
Munich, Munich (Germany) 
2. Graeser Dental Practice, Friedbergstrasse 7, 8820 
Wädenswil (Switzerland) 
Sponsor: 
Ivoclar Vivadent AG, Bendererstr. 2, 9494 Schaan (Liechtenstein) 
Clinical indication: 
Fissure sealing for caries prevention in children and 
adolescents 
Aim of the study: 
Comparison of two different fissure sealants 
Target criteria: 
Primary endpoint: 
Retention rate of the applied fissure sealants 
Secondary endpoints: 
Occurrence of caries 
Study design: 
Two-center, randomized, prospective, blinded study in a "split-mouth" 
design 
Test products 
The medical devices to be tested (Helioseal F and Helioseal F Plus) are 
assigned to class IIa. CE marking is available. 
Treatment plan: 
Sealing of at least one pair of teeth per test subject Follow-
up after 7-28 days, 6 months, 1 year, 2 years, 3 years 
Selection of patients 
From the patient pool of the trial centers 
Inclusion criteria 
Inclusion criteria for a patient 
- Indication for sealing the fissures 
- ASA status 1 
- All dentin lesions in need of restoration have been repaired 
- Consent of the parents and the patient 
- Detailed instruction and demonstration of age-appropriate oral 
hygiene, accompanying prevention concept. 
- Age: 5-13 years (Wädenswil) 
- Age: 5-18 years (Munich) 
Inclusion criteria for tooth pair to be sealed 
- 1st or 2nd permanent molars 

Clinical trial protocol for two fissure sealants  
 
 
 
Exclusion criteria 
Exclusion criteria for a patient 
- No consent of the parents / patient 
- Allergy and known intolerance reactions to methacrylates or 
other components of dental sealing/restorative materials 
Exclusion criteria for tooth pair to be sealed 
- Molars with clinical cavitations on the occlusal surface 
(UniViSS occlusal score ≥ M) 
- molars with untreated dentin lesions according to the clinical 
examination. If necessary, a bitewing radiograph is indicated. 
- Premolars, permanent anterior teeth with sealable pits, 
deciduous molars 
- Extensively restored teeth where sealable parts of the occlusal 
surface are included in the restoration. - 
- Teeth with hypomineralization or other 
structural disorders or shape anomalies 
Methodology: 
- 
Cleaning the tooth surfaces and fissures with cleaning paste 
(Proxyt green) and a rotating brush 
- 
Removal of paste residues by water rinsing 
- 
Blow the tooth surface dry well with a strong stream of air 
- 
Relative draining (LMU Munich) / rubber dam 
(Graeser dental practice) 
- 
Conditioning with a 37% phosphoric acid etching gel 
- 
Sealing of fissures and pits 
o Test group: Helioseal F Plus 
o Control group: Helioseal F 

Clinical trial protocol for two fissure sealants  
 
Statistical analysis 
The retention of the fissure sealants used is analyzed using survival 
curves (Kaplan-Meier), with the proportion of intact fissure sealants 
serving as the primary endpoint. Caries infestation and incidence serve 
as secondary endpoints. The study design was chosen to test for non-
inferiority of the newly developed sealant (Helioseal F Plus). 
 
The nQuery Advisor 6.0 program (Statistical Solutions, Saugus, MA, 
USA) was used to estimate the number of cases and a scenario for the 
non-inferiority of two fissure sealing techniques was calculated. The 
underlying assumptions are: 
 
The underlying assumptions are: 
 
- Study objective: To demonstrate the non-inferiority of the experimental 
therapy compared to the established standard therapy 
- Main outcome measure: Proportion of intact fissure sealings 
- Conjoined samples (split-mouth design) 
- Alpha level: 5% (two-sided) 
- Power: 80%  
 
 
  
N= 55 pairs of teeth per group 
As a result of the case number estimation, 55 pairs of teeth per site 
should be included. Due to an expected drop-out of about 10%, 
additional patients must be included, so that a number of 61 tooth pairs 
per group and 122 in total seems appropriate. Therefore, at least 120 
pairs of teeth are planned at the start of the study, with at least 60 pairs 
of teeth to be sealed in each study center. 
number of patients: 
120 pairs of teeth (60 per study location) 
Schedule: 
Recruitment: Following approval (from the end of Q2 2018) Baseline 
examination & sealing (T0; from the end of Q2 2018) Follow-up 
examination I  
 7-28 days after T0 
Follow-up II                     6 ± 1 months after T0 
Follow-up III 
12 ± 2 months after T0 
Follow-up IV                  24 ± 2 months after T0 
Follow-up V                   36 ± 2 months after T0 
Risk category 
according to Art. 20 
ClinO 
Category A