Clinical Performance of Two Fissure Sealants

Caries Pit and Fissure Limited to Enamel Clinical Trial

Official title:

Klinische Bewährung Zweier Fissurenversiegler

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03470129
• Other study ID #: Helioseal F Plus
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 1, 2018
• Est. completion date: December 2022

Study information

• Verified date: September 2021
• Source: Ivoclar Vivadent AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Caries Pit and Fissure Limited to Enamel

Intervention

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

Locations

Country	Name	City	State
Germany	Prof. Jan Kühnisch	München	Bavaria
Switzerland	Zahnarztpraxis Graeser	Wädenswil	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
Ivoclar Vivadent AG

Countries where clinical trial is conducted

Germany,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	caries	evaluation of the presence of carious lesions according to UniViSS 2.0	7-28 days
Secondary	caries	evaluation of the presence of carious lesions according to UniViSS 2.0	6 months
Secondary	caries	evaluation of the presence of carious lesions according to UniViSS 2.0	12 months
Secondary	caries	evaluation of the presence of carious lesions according to UniViSS 2.0	24 months