AzTrials
AzTrials

Evaluation of the Survival of Different Fissure Sealants in Partially Erupted Immature Molar Teeth at Various Eruption StagesNCT07143253

One-year Survival of Fissure Sealants in Immature Permanent Molars

A study testing Preventive pit and fissure sealant application in people with Evaluation of the Survival of Different Fissure Sealants in Partially Erupted Immature Molar Teeth at Various Eruption Stages, run by Handan Vural at 1 site in Turkey (Türkiye).

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

Dental caries remains one of the most prevalent oral diseases today. The risk of caries development is highest during the first few years following tooth eruption. Therefore, preventive strategies for dental caries continue to be of great importance. Read more about this study

Who is it for?
Ages 10 to 15 yearsHealthy volunteers can take part
What is being tested?
Preventive pit and fissure sealant application
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteTurkey (Türkiye)
Study dates
10 Sep 2025to Mar 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 10 to 15 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Healthy children aged 10-15 years.
  • Partially erupted second permanent molars that are clinically and radiographically confirmed to be caries-free or present with demineralized fissures scored as ICDAS 1-2.
  • Children demonstrating cooperative behavior, with a Frankl Behavior Rating Scale score of 3 or 4.
  • Oral Hygiene Index (OHI-S) score ≤ 3
  • Written informed consent obtained from the parent or legal guardian.

Who cannot join

  • Fully erupted or completely impacted teeth.
  • Teeth presenting with severe hypoplasia, hypomineralization, extensive restorations, or cavitated carious lesions.
  • History of systemic disease or long-term medication use.
  • Known allergy to resin-based or glass ionomer materials.
  • Presence of parafunctional habits.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Department of Pediatric Dentistry, Faculty of Dentistry, Inonu University

    Malatya, Malatya, 44200

Other trials in Turkey (Türkiye)

About this study

Official title: Evaluation of 1-year Survival Rates of Two Different Fissure Sealants Applied to Immature Permanent Molars

Dental caries remains one of the most prevalent oral diseases today. The risk of caries development is highest during the first few years following tooth eruption. Therefore, preventive strategies for dental caries continue to be of great importance.

In particular, permanent second molars are highly susceptible to caries during their eruption phase, as the enamel has not yet completed its physiological maturation. This vulnerability is especially pronounced in partially erupted teeth, where the risk of caries formation increases significantly in the absence of effective preventive measures.

Read more

In this context, fissure sealants are widely used as a preventive approach, particularly in children and adolescents, due to their proven efficacy in caries prevention. In this study, the 12-month clinical performance of resin-based hydrophilic and glass ionomer-based fissure sealants applied to partially erupted permanent first and/or second molars will be evaluated comparatively.

Informed consent will be obtained from all participants prior to their inclusion in the study. The aim of this research is to provide scientific evidence to support material selection in the field of preventive dentistry.

Previous studies (Ahovuo-Saloranta et al., 2013) have emphasized that long-term clinical success rates have a direct impact on material selection, highlighting the importance of conducting prospective clinical trials.

This study is designed as a split-mouth, double-blind, randomized, controlled clinical trial. The reporting of the study will adhere to the CONSORT (Consolidated Standards of Reporting Trials) guidelines. The study will be conducted at the Department of Pediatric Dentistry, Faculty of Dentistry, İnönü University.

Healthy children aged between 7 and 15 years will be included in the study. Randomization will be performed using a computer-assisted program. Two different fissure sealants will be applied to different teeth in each patient.

Application Procedure:

All fissure sealants will be applied by a single experienced operator in accordance with the manufacturer's instructions.

Resin-based sealants will be polymerized for 20 seconds using an LED light source.

Group A: Hydrophilic fissure sealant

Group B: Glass ionomer-based fissure sealant

Evaluation Time Points:

Immediately after application

At 3 months

At 6 months

At 12 months

The following parameters will be assessed by two independent blinded evaluators according to modified USPHS criteria:

Retention of the fissure sealant (Complete / Partial / Total loss)

Marginal discoloration

Development of secondary caries

Data will be entered into Microsoft Excel and analyzed using SPSS software. A p-value of < 0.05 will be considered statistically significant.

Read the detailed description

This study is designed to compare the 12-month survival rates of GC Fuji Triage (glass ionomer-based) and UltraSeal XT™ hydro™ (Hydrophilic Pit and Fissure Sealant) fissure sealants applied to partially erupted permanent second molars. The research will be conducted using a split-mouth, double-blind, randomized, and controlled design, aiming to provide a high level of scientific reliability through its prospective nature.

Blinding of both participants and evaluators is intended to minimize observational bias and enhance the validity of the results. The study is expected to provide evidence-based data that will guide clinicians in material selection and contribute to the existing literature in the field.

Furthermore, by being reported in accordance with the CONSORT guidelines, the study will meet international standards for clinical research reporting.

Inclusion Criteria:

Healthy children aged 10 to 15 years. Partially erupted, caries-free or demineralized fissures with ICDAS scores 1-2 on permanent second molars, confirmed by clinical and radiographic examination.

Children who demonstrate cooperative behavior, scoring 3 or 4 on the Frankl Behavior Rating Scale.

An oral hygiene score (OHI-S) ≤ 3. Written informed consent obtained from a parent or legal guardian prior to participation in the study.

Exclusion Criteria:

Fully erupted or completely impacted teeth. Teeth with severe hypoplasia, hypomineralization, presence of extensive restorations, or cavitated carious lesions.

Children with a history of systemic disease or long-term medication use. Known allergies to resin-based or glass ionomer materials. Presence of parafunctional habits (e.g., bruxism, nail biting, etc.).

Two different fissure sealants will be applied to different teeth in each patient.

Application Procedure:

All fissure sealants will be applied by a single experienced operator in accordance with the manufacturer's instructions.

Resin-based sealants will be light-cured for 20 seconds using an LED curing light.

Group A: Hydrophilic fissure sealant

Group B: Glass ionomer-based fissure sealant

Evaluation Time Points:

Immediately after application At 3 months At 6 months At 12 months

The following parameters will be evaluated by two independent blinded evaluators according to modified USPHS criteria:

Sealant retention (Complete / Partial / Total loss) Marginal discoloration Development of secondary caries

In cases where sealant loss is observed during follow-up, the material will be reapplied to the affected tooth; however, that tooth will not be included in subsequent evaluations.

Participants will not experience any disadvantage or harm due to any adverse outcome related to the materials used.

Being tested
Preventive pit and fissure sealant application
Keywords
immature molars, Fissure Sealant, Partially Erupted

What participants receive

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

  • Preventive pit and fissure sealant applicationProcedure or surgery

    Preventive pit and fissure sealant application is a preventive procedure involving the use of flowable resin-based or glass ionomer-based materials to physically cover the occlusal surfaces of teeth, particularly in pits and fissures at high risk of caries development. This barrier prevents plaque accumulation and protects the enamel surface.

    In this study, no procedures beyond the routine clinical application of the materials will be performed. However, partially erupted permanent teeth with challenging isolation will be specifically selected. Both materials will be applied using a split-mouth design to the teeth of the same participant. This approach will allow for an effective and comparative evaluation of the clinical retention of the material.

Study groups in NCT07143253
Study groupRoleWhat they receive
Gruop A:UltraSeal XT hydro sealant / hydrophillic pit and fissure sealentActive comparatorThe presence of moisture and saliva-contamination during the placement of the sealant compromise the quality of adhesion at the sealant-enamel interface, which impacts the ongoing resistance to microleakage of microorganisms. Hydrophilic sealants, which bond effectively to moist enamel surfaces, present a distinct advantage in paediatric dentistry where patient-compliance, isolation, and moisture-control can be particularly challenging.UltraSeal XT® hydro™ is a new moisture-tolerant, self-adhesive, light-cured, acrylate-based, hydrophilic pit, and fissure sealant which has been developed by Ultradent Products, USA. The sealant comprises a 53 wt% mixture of inorganic filler particles that confer radiopacity. This material is reported to "chase" moisture into the pits and fissures, thus eliminating moisture-related failure associated with hydrophobic sealants
Receives: Procedure: Preventive pit and fissure sealant application
Gruop B: GC Fuji Triage- glassionomer pit and fissure sealentActive comparatorGlass ionomer (GI)-based fissure sealants are considered a valuable treatment alternative, particularly in pediatric dentistry for patients at high risk of caries, due to their ability to chemically bond to dental tissues, release fluoride, exhibit biocompatibility, provide antibacterial effects, and promote the remineralization of hydroxyapatite crystals. The self-bonding, high-fluoride-releasing GC Fuji TRIAGE® is frequently reported in the literature as a fissure sealant, particularly for immature and partially erupted teeth. The use of glass ionomers as fissure sealants is especially emphasized in cases where isolation is difficult.
Receives: Procedure: Preventive pit and fissure sealant application

What is being measured

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

  1. Modified Simonsen Criteria

    Score 0 Fissure sealant is completely in the mouth and there is no new caries.

    Score 1 Partial loss of fissure sealant, no new caries.

    Score 2 Partial loss of fissure sealant and new caries.

    Score 3 Complete loss of fissure sealant, no new caries.

    Score 4 Complete loss of fissure sealant and new caries

    Measured: Follow-up appointments were scheduled for children at 3, 6, and 12 months following the initial treatment.

  2. Edge Integrity Evaluation Criteria

    0: The fissure sealant and tooth surface are intact and cannot be distinguished with a probe.

    1. The edges of the fissure sealants can be distinguished with a probe.
    2. There is a gap along the edge of the fissure sealant and deep cracks reaching the central fossa

    Measured: Follow-up appointments were scheduled for children at 3, 6, and 12 months following the initial treatment

  3. Marginal Coloration Evaluation Criteria

    0 No color change between fissure sealant and tooth.

    1. Color change in only one area.
    2. Color change in many areas.
    3. Severe color change indicating leakage.

    Measured: Follow-up appointments were scheduled for children at 3, 6, and 12 months following the initial treatment

  4. Anatomical Form Evaluation Criteria

    0 Consistent with and continuous with occlusal form and structure.

    1. Change in anatomical form but all pits and fissures covered.
    2. a Partial loss of one or two pits or fissures but no need to repair or replace fissure sealant.

    2b Partial loss of pits and fissures, fissure sealant needs to be replaced or repaired.

    3 Loss of all pits and fissures. 7 Partial loss due to occlusion 9 Bleb not connected to margins

    Measured: Follow-up appointments were scheduled for children at 3, 6, and 12 months following the initial treatment.

Timeline

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

  1. First posted27 Aug 2025
  2. Study start10 Sep 2025
  3. Primary completion8 Feb 2026
  4. Study completionMar 2027 (estimated)

Resources

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
In this split-mouth designed study, at least two partially erupted molar teeth from each patient will be included. A random group allocation will be performed, and the appropriate fissure sealant will be applied according to the assigned group.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07143253
Sponsor's protocol ID
7699
Status last verified
Apr 2026
First submitted
10 Aug 2025
Last updated
23 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: IPD used in the results publication

Publications

  • Penha KJS, Roma FRVO, Filho EMM, Ribeiro CCC, Firoozmand LM. Bioactive self-etching sealant on newly erupted molars: A split-mouth clinical trial. J Dent. 2021 Dec;115:103857. doi: 10.1016/j.jdent.2021.103857. Epub 2021 Oct 24.

    PubMed 34699954
  • Antonson SA, Antonson DE, Brener S, Crutchfield J, Larumbe J, Michaud C, Yazici AR, Hardigan PC, Alempour S, Evans D, Ocanto R. Twenty-four month clinical evaluation of fissure sealants on partially erupted permanent first molars: glass ionomer versus resin-based sealant. J Am Dent Assoc. 2012 Feb;143(2):115-22. doi: 10.14219/jada.archive.2012.0121.

    PubMed 22298552

Questions about this trial

What is this clinical trial studying?

A study testing Preventive pit and fissure sealant application in people with Evaluation of the Survival of Different Fissure Sealants in Partially Erupted Immature Molar Teeth at Various Eruption Stages, run by Handan Vural 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 5 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 23 Apr 2026. 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?

This study is still under way. Results are not available in the source record yet.

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?

Modified Simonsen Criteria (time frame: Follow-up appointments were scheduled for children at 3, 6, and 12 months following the initial treatment.). 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 NCT07143253, which also lists 2 linked publications.

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 23 Apr 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in