Dental CariesFISSURE24NCT07115290
Comparative Evaluation of Glass Ionomer and Resin-Based Fissure Sealants on Newly Erupted Permanent First Molars: A 24-Month Randomized Clinical Trial
A study testing Glass ionomer-based fissure sealant and Resin-based fissure sealant in people with Dental Caries and Fissure Sealants, run by Gulcin Bulut at 1 site in Turkey (Türkiye).
Trial summary
This clinical study aims to compare the clinical performance of two different fissure sealant materials-glass ionomer and resin-based-when applied to newly erupted permanent first molars in children. Read more about this study
- Who is it for?
- Ages 6 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries, Fissure Sealants, Permanent Molars
- What is being tested?
- Glass ionomer-based fissure sealant and Resin-based fissure sealant
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Apr 2023to 20 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 6 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged 6-7 years
- Children who are systemically healthy and classified as ASA I and II16
- Children whose parents and themselves have agreed to attend the study and follow-up visits throughout the study period
- Children who have established oral hygiene habits
Who cannot join
- Children whose caregivers did not sign the informed consent form, and patients who wished to withdraw or for whom the treatment protocol was not properly followed.
- Children who have restorations, cavitated surfaces or developmental defects and hypoplasia on the permanent first molar teeth to be treated.
- Medically compromised and children who need special treatment.
- History of adverse reactions to any restorative materials.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Dokuz Eylul University, Faculty of Dentistry, Department of Pediatric Dentistry
Izmir, İzmir, 35340
About this study
This clinical study aims to compare the clinical performance of two different fissure sealant materials-glass ionomer and resin-based-when applied to newly erupted permanent first molars in children. The study evaluates which material provides better retention, marginal adaptation, and protection against dental caries over a 24-month period.
Read the detailed description
This randomized, split-mouth, clinical study was designed to compare the clinical effectiveness of two different fissure sealant materials-glass ionomer-based (Fuji Triage™ Capsule) and moisture-tolerant resin-based (UltraSeal XT® Hydro)-in newly erupted permanent first molars in children aged 6-7 years.
The study evaluates the retention rates, marginal adaptation, marginal discoloration, and the ability of each material to prevent dental caries over a 24-month follow-up period. A total of 70 teeth from 35 children were sealed using a split-mouth design, ensuring that each participant received both types of sealants on contralateral molars. Clinical evaluations were performed at 1, 6, 12, 18, and 24 months using modified United States Public Health Service (USPHS) criteria.
The goal of the study is to determine whether the moisture-tolerant resin-based material offers a clinical advantage in terms of sealant retention and caries prevention in a partially erupted, moisture-challenged clinical environment.
- Conditions
- Dental Caries, Fissure Sealants, Permanent Molars, Child, Healthy Volunteers
- Being tested
- Glass ionomer-based fissure sealant, Resin-based fissure sealant
- Keywords
- Dental caries, Fissure sealant, Glass ionomer, Resin-based sealant, Moisture-tolerant, Retention, Permanent molar, Children, Split-mouth design, Randomized clinical trial, Marginal adaptation, USPHS criteria
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glass ionomer-based fissure sealantDevice
Also called Fuji Triage, Glass ionomer fissure sealant, GC Fuji Triage, GIC sealant
A high-viscosity, self-curing glass ionomer sealant used for the occlusal surfaces of newly erupted permanent molars. This material releases fluoride and is moisture-tolerant during application. The product used in this study was Fuji Triage™ Capsule (GC Corporation, Japan).
Resin-based fissure sealantDevice
Also called UltraSeal XT Hydro, Moisture-tolerant resin sealant, Hydrophilic sealant
A moisture-tolerant, light-cured resin-based fissure sealant designed for application to occlusal surfaces in partially erupted permanent molars. The material exhibits strong adhesion in moist conditions and forms a durable barrier against caries. The product used in this study was UltraSeal XT® Hydro (Ultradent Products Inc., USA).
| Study group | Role | What they receive |
|---|---|---|
| Glass Ionomer Sealant Arm | Active comparator | In this arm, a high-viscosity glass ionomer-based fissure sealant (Fuji Triage™ Capsule, GC Corporation, Tokyo, Japan) was applied to one of the newly erupted permanent first molars of each participant using a split-mouth design. Receives: Device: Glass ionomer-based fissure sealant |
| Resin-Based Sealant Arm | Active comparator | In this arm, a moisture-tolerant resin-based fissure sealant (UltraSeal XT® Hydro, Ultradent Products Inc., South Jordan, UT, USA) was applied to the contralateral newly erupted permanent first molar of the same participant, using the split-mouth method. Receives: Device: Resin-based fissure sealant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sealant retention
Assessment of the retention of the fissure sealant material on the occlusal surface of the first permanent molars using modified USPHS criteria. Evaluated at 1, 6, 12, 18, and 24 months.
Measured: 1, 6, 12, 18, and 24 months
Secondary outcomes (3)
Marginal adaptation
Evaluation of the marginal adaptation of the sealant to the tooth structure using modified USPHS criteria.
Measured: 1, 6, 12, 18, and 24 months
Marginal discoloration
Assessment of any marginal discoloration of the sealant using modified USPHS criteria.
Measured: 1, 6, 12, 18, and 24 months
Presence of caries
Detection of carious lesions on sealed occlusal surfaces throughout the follow-up period.
Measured: 1, 6, 12, 18, and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study start10 Apr 2023
- Primary completion20 May 2025
- Study completion20 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CariesStudies 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
- Crossover
- Model description
- This study employed a split-mouth crossover design in which each participant received both interventions. One first permanent molar on the right or left side of the same dental arch was sealed with a glass ionomer-based sealant, while the contralateral molar on the opposite side of the same arch received a moisture-tolerant resin-based sealant. This design minimizes inter-subject variability and allows for a direct comparison within the same oral environment.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gulcin Bulut
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Gulcin Bulut, Dokuz Eylul University
- Investigators
- Gulcin F Bulut, DDS, PhD, Principal investigator, Dokuz Eylul University, Faculty of Dentistry, Department of Pediatric Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07115290
- Sponsor's protocol ID
- 612-SBKAEK
- Other IDs
- TİTCK-2023-067
- Acronym
- FISSURE24
- Status last verified
- Aug 2025
- First submitted
- 4 Aug 2025
- Last updated
- 11 Aug 2025
- Results posted
- No
- 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 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Glass Ionomer and Resin-Based Fissure Sealants on Newly Erupted Permanent First Molars: A 24-Month Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07115290
- Acronym / sponsor ID
- FISSURE24 / 612-SBKAEK
- Conditions
- Dental Caries, Fissure Sealants, Permanent Molars, Child, Healthy Volunteers
- Keywords
- Dental caries, Fissure sealant, Glass ionomer, Resin-based sealant, Moisture-tolerant, Retention, Permanent molar, Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Gulcin BulutUniversity, hospital or other
- Study start
- 10 Apr 2023 (actual)
- Primary completion
- 20 May 2025 (actual)
- Study completion
- 20 Jun 2025 (actual)
- First posted
- 11 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical study aims to compare the clinical performance of two different fissure sealant materials-glass ionomer and resin-based-when applied to newly erupted permanent first molars in children. The study evaluates which material provides better retention, marginal adaptation, and protection against dental caries over a 24-month period.
Detailed description
This randomized, split-mouth, clinical study was designed to compare the clinical effectiveness of two different fissure sealant materials-glass ionomer-based (Fuji Triage™ Capsule) and moisture-tolerant resin-based (UltraSeal XT® Hydro)-in newly erupted permanent first molars in children aged 6-7 years.
The study evaluates the retention rates, marginal adaptation, marginal discoloration, and the ability of each material to prevent dental caries over a 24-month follow-up period. A total of 70 teeth from 35 children were sealed using a split-mouth design, ensuring that each participant received both types of sealants on contralateral molars. Clinical evaluations were performed at 1, 6, 12, 18, and 24 months using modified United States Public Health Service (USPHS) criteria.
The goal of the study is to determine whether the moisture-tolerant resin-based material offers a clinical advantage in terms of sealant retention and caries prevention in a partially erupted, moisture-challenged clinical environment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This study employed a split-mouth crossover design in which each participant received both interventions. One first permanent molar on the right or left side of the same dental arch was sealed with a glass ionomer-based sealant, while the contralateral molar on the opposite side of the same arch received a moisture-tolerant resin-based sealant. This design minimizes inter-subject variability and allows for a direct comparison within the same oral environment.
| Arm | Type | Receives |
|---|---|---|
| Glass Ionomer Sealant Arm | Active comparator | Device: Glass ionomer-based fissure sealantIn this arm, a high-viscosity glass ionomer-based fissure sealant (Fuji Triage™ Capsule, GC Corporation, Tokyo, Japan) was applied to one of the newly erupted permanent first molars of each participant using a split-mouth design. |
| Resin-Based Sealant Arm | Active comparator | Device: Resin-based fissure sealantIn this arm, a moisture-tolerant resin-based fissure sealant (UltraSeal XT® Hydro, Ultradent Products Inc., South Jordan, UT, USA) was applied to the contralateral newly erupted permanent first molar of the same participant, using the split-mouth method. |
Who may qualify
- Ages
- 6 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children aged 6-7 years
- Children who are systemically healthy and classified as ASA I and II16
- Children whose parents and themselves have agreed to attend the study and follow-up visits throughout the study period
- Children who have established oral hygiene habits
Key exclusion criteria (4 listed)
- Children whose caregivers did not sign the informed consent form, and patients who wished to withdraw or for whom the treatment protocol was not properly followed.
- Children who have restorations, cavitated surfaces or developmental defects and hypoplasia on the permanent first molar teeth to be treated.
- Medically compromised and children who need special treatment.
- History of adverse reactions to any restorative materials.
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 |
|---|---|---|
| Glass ionomer-based fissure sealantAlso: Fuji Triage, Glass ionomer fissure sealant, GC Fuji Triage, GIC sealantA high-viscosity, self-curing glass ionomer sealant used for the occlusal surfaces of newly erupted permanent molars. This material releases fluoride and is moisture-tolerant during application. The product used in this study was Fuji Triage™ Capsule (GC Corporation, Japan). | Device | Glass Ionomer Sealant Arm |
| Resin-based fissure sealantAlso: UltraSeal XT Hydro, Moisture-tolerant resin sealant, Hydrophilic sealantA moisture-tolerant, light-cured resin-based fissure sealant designed for application to occlusal surfaces in partially erupted permanent molars. The material exhibits strong adhesion in moist conditions and forms a durable barrier against caries. The product used in this study was UltraSeal XT® Hydro (Ultradent Products Inc., USA). | Device | Resin-Based Sealant Arm |
Primary outcome
Sealant retention
Time frame: 1, 6, 12, 18, and 24 months
Assessment of the retention of the fissure sealant material on the occlusal surface of the first permanent molars using modified USPHS criteria. Evaluated at 1, 6, 12, 18, and 24 months.
3 secondary outcomes
Marginal adaptation
Time frame: 1, 6, 12, 18, and 24 months
Marginal discoloration
Time frame: 1, 6, 12, 18, and 24 months
Presence of caries
Time frame: 1, 6, 12, 18, and 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2025.
- Individual participant dataSharing planned: No
Related trials for Dental Caries
Active, not recruiting
Clinical Evaluation of a New Dual-cure Universal Adhesive
Class I Dental Restorations, Class II Dental Restorations
Not yet recruiting
Safety of Intraosseous Anaesthesia in Children With Haemophilia
Haemophilia A, Haemophilia B
Not yet recruiting
Clinical and Radiographic Evaluation of Silver Diamine Fluoride Versus Light-Cured Silver Diamine Fluoride in Carious Primary Molars
Dental Caries
Not yet recruiting
Clinical Performance of CAD/CAM Hard Hybrid Ceramic Inlays Versus Resin Composite Inlays in Vital Molars With Extensive Occluso-Proximal Cavities
Dental Caries, Cavity, Dental
Not yet recruiting
Effect of Xylitol- Versus Erythritol-Sweetened Mints on Plaque ATP-Bioluminescence Readings
Dental Caries, Dental Plaque
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.
Gulcin F Bulut, DDS, PhD principal investigator
Dokuz Eylul University, Faculty of Dentistry, Department of Pediatric Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glass ionomer-based fissure sealant and Resin-based fissure sealant in people with Dental Caries and Fissure Sealants, run by Gulcin Bulut at 1 site in Turkey (Türkiye).
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 4 inclusion and 4 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 11 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Sealant retention (time frame: 1, 6, 12, 18, and 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Aug 2025.