Trial Outcomes & Findings for Clinical Performance of Two Fissure Sealants (NCT NCT03470129)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

92 participants

Primary outcome timeframe

7-28 days

Results posted on

2025-04-08

Participant Flow

The recruitment phase took place at both study sites from September 2018 to March 2019.

Unit of analysis: Sealants

Participant milestones

Participant milestones
Measure	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	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
Overall Study STARTED	92 164	92 164
Overall Study 12 Month	85 152	85 153
Overall Study 24 Month	82 148	82 149
Overall Study COMPLETED	76 134	76 131
Overall Study NOT COMPLETED	16 30	16 33

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Helioseal F n=164 Sealants 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	Helioseal F Plus n=164 Sealants 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	Total n=328 Sealants Total of all reporting groups
Age, Customized 5-18 years	92 Participants n=92 Participants	92 Participants n=92 Participants	92 Participants n=92 Participants
Sex/Gender, Customized Female	51 participants n=92 Participants	51 participants n=92 Participants	51 participants n=92 Participants
Sex/Gender, Customized Male	41 participants n=92 Participants	41 participants n=92 Participants	41 participants n=92 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Switzerland	41 participants n=92 Participants • Herein, the participants	41 participants n=92 Participants • Herein, the participants	41 participants n=92 Participants • Herein, the participants
Region of Enrollment Germany	51 participants n=92 Participants • Herein, the participants	51 participants n=92 Participants • Herein, the participants	51 participants n=92 Participants • Herein, the participants

PRIMARY outcome

Timeframe: 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

Outcome measures

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

PRIMARY outcome

Timeframe: 12 months

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

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

Outcome measures

Outcome measures
Measure	Helioseal F n=152 Sealants 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	Helioseal F Plus n=153 Sealants 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
Retention of Sealant 0 - no fissure sealant left/present	2 Sealants	2 Sealants
Retention of Sealant 1 complete retention	111 Sealants	116 Sealants
Retention of Sealant 2 minimal loss of sealant (max one third)	24 Sealants	21 Sealants
Retention of Sealant 3: central retention of the sealant	13 Sealants	6 Sealants
Retention of Sealant 4: almost complete loss of the sealant - less than one third is left	2 Sealants	8 Sealants

PRIMARY outcome

Timeframe: 24 months

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

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

Outcome measures

Outcome measures
Measure	Helioseal F n=148 Sealants 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	Helioseal F Plus n=149 Sealants 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
Retention of Sealant 0 - no fissure sealant left/present	0 Sealants	2 Sealants
Retention of Sealant 1 complete retention	100 Sealants	101 Sealants
Retention of Sealant 2 minimal loss of sealant (max one third)	28 Sealants	27 Sealants
Retention of Sealant 3: central retention of the sealant	14 Sealants	11 Sealants
Retention of Sealant 4: almost complete loss of the sealant - less than one third is left	6 Sealants	8 Sealants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Helioseal F n=134 Sealants 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	Helioseal F Plus n=131 Sealants 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
Retention of Sealant 0 - no fissure sealant left/present	0 Sealants	0 Sealants
Retention of Sealant 1 complete retention	84 Sealants	81 Sealants
Retention of Sealant 2 minimal loss of sealant (max one third)	29 Sealants	26 Sealants
Retention of Sealant 3: central retention of the sealant	15 Sealants	12 Sealants
Retention of Sealant 4: almost complete loss of the sealant - less than one third is left	6 Sealants	12 Sealants

SECONDARY outcome

Timeframe: 7-28 days

evaluation of the presence of carious lesions according to UniViSS 2.0

Outcome measures

Outcome measures
Measure	Helioseal F n=164 Sealants 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	Helioseal F Plus n=164 Sealants 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
Caries No Caries	164 Sealants	164 Sealants
Caries Non-cavitated caries	0 Sealants	0 Sealants
Caries Cavitated caries	0 Sealants	0 Sealants

SECONDARY outcome

Timeframe: 12 months

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

evaluation of the presence of carious lesions according to UniViSS 2.0

Outcome measures

Outcome measures
Measure	Helioseal F n=152 Sealants 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	Helioseal F Plus n=153 Sealants 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
Caries No caries	151 Sealants	151 Sealants
Caries Non-cavitated caries	1 Sealants	2 Sealants
Caries Cavitated caries	0 Sealants	0 Sealants

SECONDARY outcome

Timeframe: 24 months

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

evaluation of the presence of carious lesions according to UniViSS 2.0

Outcome measures

Outcome measures
Measure	Helioseal F n=148 Sealants 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	Helioseal F Plus n=149 Sealants 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
Caries No caries	146 Sealants	146 Sealants
Caries Non-cavitated caries	2 Sealants	3 Sealants
Caries Cavitated caries	0 Sealants	0 Sealants

SECONDARY outcome

Timeframe: 36 months

evaluation of the presence of carious lesions according to UniViSS 2.0

Outcome measures

Outcome measures
Measure	Helioseal F n=134 Sealants 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	Helioseal F Plus n=131 Sealants 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
Caries No caries	123 Sealants	120 Sealants
Caries Non-cavitated caries	11 Sealants	11 Sealants
Caries Cavitated caries	0 Sealants	0 Sealants

Adverse Events

Helioseal F

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Helioseal F Plus

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Team Leader Study Management

Ivoclar Vivadent AG

Phone: +4232353780

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 30 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
Publication restrictions are in place

Restriction type: OTHER