Caries Pit and Fissure Limited to Enamel
Conditions
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
Interventions
DEVICEfissure 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
Sponsors
Ivoclar Vivadent AG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
5 Years to 18 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Retention of the Sealant | 7-28 days | 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 |
| Retention of Sealant | 12 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Caries | 7-28 days | evaluation of the presence of carious lesions according to UniViSS 2.0 |
Countries
Germany, Switzerland
Participant flow
Recruitment details
The recruitment phase took place at both study sites from September 2018 to March 2019.
Participants by arm
| Arm | Count |
|---|---|
| Helioseal F fissure sealing with the conventional product
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 | 92 |
| Helioseal F fissure sealing with the conventional product
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 | 164 |
| Helioseal F Plus fissure sealing with the new product
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 | 92 |
| Helioseal F Plus fissure sealing with the new product
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 | 164 |
| Total | 512 |
Baseline characteristics
| Characteristic | Total | Helioseal F Plus | Helioseal F |
|---|---|---|---|
| Age, Customized 5-18 years | 92 Participants | 92 Participants | 92 Participants |
| Race and Ethnicity Not Collected | 0 Participants | — | — |
| Region of Enrollment Germany | 51 participants | 51 participants | 51 participants |
| Region of Enrollment Switzerland | 41 participants | 41 participants | 41 participants |
| Sex/Gender, Customized Female | 51 participants | 51 participants | 51 participants |
| Sex/Gender, Customized Male | 41 participants | 41 participants | 41 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 92 | 0 / 92 |
| other Total, other adverse events | 0 / 92 | 0 / 92 |
| serious Total, serious adverse events | 0 / 92 | 0 / 92 |
Outcome results
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
Time frame: 12 months
Population: One Sealant of Helioseal F could not be examined due to an orthodontic bite device.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Helioseal F | Retention of Sealant | 1 complete retention | 111 Sealants |
| Helioseal F | Retention of Sealant | 3: central retention of the sealant | 13 Sealants |
| Helioseal F | Retention of Sealant | 2 minimal loss of sealant (max one third) | 24 Sealants |
| Helioseal F | Retention of Sealant | 4: almost complete loss of the sealant - less than one third is left | 2 Sealants |
| Helioseal F | Retention of Sealant | 0 - no fissure sealant left/present | 2 Sealants |
| Helioseal F Plus | Retention of Sealant | 4: almost complete loss of the sealant - less than one third is left | 8 Sealants |
| Helioseal F Plus | Retention of Sealant | 0 - no fissure sealant left/present | 2 Sealants |
| Helioseal F Plus | Retention of Sealant | 1 complete retention | 116 Sealants |
| Helioseal F Plus | Retention of Sealant | 2 minimal loss of sealant (max one third) | 21 Sealants |
| Helioseal F Plus | Retention of Sealant | 3: central retention of the sealant | 6 Sealants |
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
Time frame: 24 months
Population: One Sealant of Helioseal F could not be examined due to an orthodontic bite device.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Helioseal F | Retention of Sealant | 1 complete retention | 100 Sealants |
| Helioseal F | Retention of Sealant | 2 minimal loss of sealant (max one third) | 28 Sealants |
| Helioseal F | Retention of Sealant | 3: central retention of the sealant | 14 Sealants |
| Helioseal F | Retention of Sealant | 0 - no fissure sealant left/present | 0 Sealants |
| Helioseal F | Retention of Sealant | 4: almost complete loss of the sealant - less than one third is left | 6 Sealants |
| Helioseal F Plus | Retention of Sealant | 4: almost complete loss of the sealant - less than one third is left | 8 Sealants |
| Helioseal F Plus | Retention of Sealant | 1 complete retention | 101 Sealants |
| Helioseal F Plus | Retention of Sealant | 0 - no fissure sealant left/present | 2 Sealants |
| Helioseal F Plus | Retention of Sealant | 2 minimal loss of sealant (max one third) | 27 Sealants |
| Helioseal F Plus | Retention of Sealant | 3: central retention of the sealant | 11 Sealants |
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
Time frame: 36 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Helioseal F | Retention of Sealant | 1 complete retention | 84 Sealants |
| Helioseal F | Retention of Sealant | 3: central retention of the sealant | 15 Sealants |
| Helioseal F | Retention of Sealant | 2 minimal loss of sealant (max one third) | 29 Sealants |
| Helioseal F | Retention of Sealant | 4: almost complete loss of the sealant - less than one third is left | 6 Sealants |
| Helioseal F | Retention of Sealant | 0 - no fissure sealant left/present | 0 Sealants |
| Helioseal F Plus | Retention of Sealant | 4: almost complete loss of the sealant - less than one third is left | 12 Sealants |
| Helioseal F Plus | Retention of Sealant | 0 - no fissure sealant left/present | 0 Sealants |
| Helioseal F Plus | Retention of Sealant | 1 complete retention | 81 Sealants |
| Helioseal F Plus | Retention of Sealant | 2 minimal loss of sealant (max one third) | 26 Sealants |
| Helioseal F Plus | Retention of Sealant | 3: central retention of the sealant | 12 Sealants |
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
Time frame: 7-28 days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Helioseal F | Retention of the Sealant | 1 complete retention | 164 Sealants |
| Helioseal F | Retention of the Sealant | 3: central retention of the sealant, | 0 Sealants |
| Helioseal F | Retention of the Sealant | 2 minimal loss of sealant (max one third) | 0 Sealants |
| Helioseal F | Retention of the Sealant | 4: almost complete loss of the sealant - less than one third is left | 0 Sealants |
| Helioseal F | Retention of the Sealant | 0 - no fissure sealant left/present | 0 Sealants |
| Helioseal F Plus | Retention of the Sealant | 4: almost complete loss of the sealant - less than one third is left | 0 Sealants |
| Helioseal F Plus | Retention of the Sealant | 0 - no fissure sealant left/present | 0 Sealants |
| Helioseal F Plus | Retention of the Sealant | 1 complete retention | 164 Sealants |
| Helioseal F Plus | Retention of the Sealant | 2 minimal loss of sealant (max one third) | 0 Sealants |
| Helioseal F Plus | Retention of the Sealant | 3: central retention of the sealant, | 0 Sealants |
Secondary
Caries
evaluation of the presence of carious lesions according to UniViSS 2.0
Time frame: 36 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Helioseal F | Caries | No caries | 123 Sealants |
| Helioseal F | Caries | Non-cavitated caries | 11 Sealants |
| Helioseal F | Caries | Cavitated caries | 0 Sealants |
| Helioseal F Plus | Caries | No caries | 120 Sealants |
| Helioseal F Plus | Caries | Non-cavitated caries | 11 Sealants |
| Helioseal F Plus | Caries | Cavitated caries | 0 Sealants |
Secondary
Caries
evaluation of the presence of carious lesions according to UniViSS 2.0
Time frame: 7-28 days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Helioseal F | Caries | No Caries | 164 Sealants |
| Helioseal F | Caries | Non-cavitated caries | 0 Sealants |
| Helioseal F | Caries | Cavitated caries | 0 Sealants |
| Helioseal F Plus | Caries | No Caries | 164 Sealants |
| Helioseal F Plus | Caries | Non-cavitated caries | 0 Sealants |
| Helioseal F Plus | Caries | Cavitated caries | 0 Sealants |
Secondary
Caries
evaluation of the presence of carious lesions according to UniViSS 2.0
Time frame: 12 months
Population: One Sealant of Helioseal F could not be examined due to an orthodontic bite device.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Helioseal F | Caries | No caries | 151 Sealants |
| Helioseal F | Caries | Non-cavitated caries | 1 Sealants |
| Helioseal F | Caries | Cavitated caries | 0 Sealants |
| Helioseal F Plus | Caries | No caries | 151 Sealants |
| Helioseal F Plus | Caries | Non-cavitated caries | 2 Sealants |
| Helioseal F Plus | Caries | Cavitated caries | 0 Sealants |
Secondary
Caries
evaluation of the presence of carious lesions according to UniViSS 2.0
Time frame: 24 months
Population: One Sealant of Helioseal F could not be examined due to an orthodontic bite device.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Helioseal F | Caries | No caries | 146 Sealants |
| Helioseal F | Caries | Non-cavitated caries | 2 Sealants |
| Helioseal F | Caries | Cavitated caries | 0 Sealants |
| Helioseal F Plus | Caries | No caries | 146 Sealants |
| Helioseal F Plus | Caries | Non-cavitated caries | 3 Sealants |
| Helioseal F Plus | Caries | Cavitated caries | 0 Sealants |