NCT03470129 - Clinical Performance of Two Fissure Sealants | Crick

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

92

Conditions

Caries Pit and Fissure Limited to Enamel

Interventions

fissure sealingDEVICE

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

Eligibility

Sex: ALLMin age: 5 YearsMax age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

Prof. Jan Kühnisch

München, Bavaria, Germany

Zahnarztpraxis Graeser

Wädenswil, Canton of Zurich, Switzerland

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 36 months

Secondary Outcomes

Caries

evaluation of the presence of carious lesions according to UniViSS 2.0

Time frame: 7-28 days

Caries

evaluation of the presence of carious lesions according to UniViSS 2.0

Time frame: 12 months

Caries

evaluation of the presence of carious lesions according to UniViSS 2.0