Clinical Performance of Two Fissure Sealants

Study Overview
=================
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

Official Title
-----------------
Klinische Bewährung Zweier Fissurenversiegler

Conditions
-----------------
Caries Pit and Fissure Limited to Enamel

Intervention / Treatment
-----------------
* Device: fissure sealing


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Helioseal F<br>fissure sealing with the conventional product | Device: fissure sealing<br>* 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<br>|
| Experimental: Helioseal F Plus<br>fissure sealing with the new product | Device: fissure sealing<br>* 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<br>|

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 | 6 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 | 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 | 

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 | 6 months | 
| 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 |