Caries Pit and Fissure Limited to EnamelNCT03470129

Clinical Performance of Two Fissure Sealants

A study testing fissure sealing in people with Caries Pit and Fissure Limited to Enamel, run by Ivoclar Vivadent AG at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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 Read more about this study

Who is it for?: Ages 5 to 18 yearsHealthy volunteers can take part
Conditions the study is for: Caries Pit and Fissure Limited to Enamel
What is being tested?: fissure sealing
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 92 participants
Where: 2 sitesin 2 countries
Study dates: 1 Sep 2018to 14 Mar 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 5 to 18 years
All sexes
Healthy volunteers accepted
Child, Adult

Who may be able to join

participants
ASA Status 1
all dentinal lesions are restored
consent of parents and patient
instruction and demonstration of oral hygiene
teeth:

Show all 9Show fewer

first and second molars of the permanent dentition
healthy teeth without caries
molars with primary lesions

Who cannot join

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

Show all 9Show fewer

premolars, incisors, deciduous teeth
teeth with huge occlusal restorations
hypomineralized teeth or other defects

Trial locations and contacts

2 sites in 2 countries.

Country

City, postcode or hospital

2 sites in 2 countries

Germany1 site

Prof. Jan Kühnisch
München, Bavaria, 80336

Other trials in Germany

Switzerland1 site

Zahnarztpraxis Graeser
Wädenswil, Canton of Zurich, 8820

Other trials in Switzerland

About this study

Official title: Klinische Bewährung Zweier Fissurenversiegler

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

Conditions: Caries Pit and Fissure Limited to Enamel
Being tested: fissure sealing

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT03470129
Study group	Role	What they receive
Helioseal F	Active comparator	fissure sealing with the conventional product Receives: Device: fissure sealing
Helioseal F Plus	Experimental	fissure sealing with the new product Receives: Device: fissure sealing

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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
Measured: 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
Measured: 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
Measured: 36 months

Secondary outcomes (4)

Caries
evaluation of the presence of carious lesions according to UniViSS 2.0
Measured: 7-28 days
Caries
evaluation of the presence of carious lesions according to UniViSS 2.0
Measured: 12 months
Caries
evaluation of the presence of carious lesions according to UniViSS 2.0
Measured: 24 months
Caries
evaluation of the presence of carious lesions according to UniViSS 2.0
Measured: 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Sep 201814 Mar 2022

First posted19 Mar 2018
Study start1 Sep 2018
Primary completion14 Mar 2022
Study completion14 Mar 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Caries Pit and Fissure Limited to EnamelStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 92 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03470129
Sponsor's protocol ID: Helioseal F Plus
Status last verified: Apr 2025
First submitted: 6 Mar 2018
Last updated: 8 Apr 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Klinische Bewährung Zweier Fissurenversiegler
ClinicalTrials.gov ID: NCT03470129
Acronym / sponsor ID: Helioseal F Plus
Conditions: Caries Pit and Fissure Limited to Enamel
Study type: Interventional
Recruitment status: Completed
Enrolment: 92 participants (actual)
Lead sponsor: Ivoclar Vivadent AGIndustry (pharma, biotech, devices)
Study start: 1 Sep 2018 (actual)
Primary completion: 14 Mar 2022 (actual)
Study completion: 14 Mar 2022 (actual)
First posted: 19 Mar 2018 (actual)
Results: Posted 8 Apr 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Helioseal F	Active comparator	Device: fissure sealingfissure sealing with the conventional product
Helioseal F Plus	Experimental	Device: fissure sealingfissure sealing with the new product

Who may qualify

Ages: 5 to 18 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult

Key inclusion criteria (9 listed)

participants
ASA Status 1
all dentinal lesions are restored
consent of parents and patient
instruction and demonstration of oral hygiene

Key exclusion criteria (9 listed)

participants
no consent
allergies to methacrylates or other ingredients of dental products
molars with occlusal cavities (UniViSS score occlusal > M)
Molars with untreated dentinal lesions

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
fissure sealingsealing 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	Device	Helioseal F, Helioseal F Plus

Primary outcome

Retention of the Sealant
Time frame: 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
Time frame: 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
Retention of Sealant
Time frame: 24 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
Retention of Sealant
Time frame: 36 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

4 secondary outcomes

Caries
Time frame: 7-28 days
Caries
Time frame: 12 months
Caries
Time frame: 24 months
Caries
Time frame: 36 months

Results and safety

Results posted to the registry on 8 Apr 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Helioseal F	92	76
Helioseal F Plus	92	76

Primary outcome: Retention of the Sealant

Time frame: 7-28 days. Number. Unit: Sealants

Measure	Helioseal F n = 92	Helioseal F Plus n = 92
0 - no fissure sealant left/present	0	0
1 complete retention	164	164
2 minimal loss of sealant (max one third)	0	0
3: central retention of the sealant,	0	0
4: almost complete loss of the sealant - less than one third is left	0	0

Primary outcome: Retention of Sealant

Time frame: 12 months. Number. Unit: Sealants

Measure	Helioseal F n = 85	Helioseal F Plus n = 85
0 - no fissure sealant left/present	2	2
1 complete retention	111	116
2 minimal loss of sealant (max one third)	24	21
3: central retention of the sealant	13	6
4: almost complete loss of the sealant - less than one third is left	2	8

Population analysed: One Sealant of Helioseal F could not be examined due to an orthodontic bite device.

Primary outcome: Retention of Sealant

Time frame: 24 months. Number. Unit: Sealants

Measure	Helioseal F n = 82	Helioseal F Plus n = 82
0 - no fissure sealant left/present	0	2
1 complete retention	100	101
2 minimal loss of sealant (max one third)	28	27
3: central retention of the sealant	14	11
4: almost complete loss of the sealant - less than one third is left	6	8

Population analysed: One Sealant of Helioseal F could not be examined due to an orthodontic bite device.

Primary outcome: Retention of Sealant

Time frame: 36 months. Number. Unit: Sealants

Measure	Helioseal F n = 76	Helioseal F Plus n = 76
0 - no fissure sealant left/present	0	0
1 complete retention	84	81
2 minimal loss of sealant (max one third)	29	26
3: central retention of the sealant	15	12
4: almost complete loss of the sealant - less than one third is left	6	12

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 36 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Helioseal F	0 of 92 (0%)	0 of 92 (0%)	0 of 92
Helioseal F Plus	0 of 92 (0%)	0 of 92 (0%)	0 of 92

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

2 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing fissure sealing in people with Caries Pit and Fissure Limited to Enamel, run by Ivoclar Vivadent AG at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Germany, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Retention of the Sealant (time frame: 7-28 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03470129.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2025.