Pre-etched Bioactive Versus Resin- Based Fissure Sealant for Permanent Molars Affected With Molar Incisor Hypomineralization (MIH).

August 9, 2026 updated by: Jordan University of Science and Technology

Pre-etched Bioactive Versus Resin- Based Fissure Sealant for Permanent Molars Affected With Molar Incisor Hypomineralization (MIH): A Randomized Clinical Trial

This study aims to evaluate and compare the clinical performance of pre-etched bioactive fissure sealants to conventional RBFS in permanent molars affected by MIH in terms of retention, marginal integrity, caries prevention effect, and sensitivity.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Molar Incisor Hypomineralization (MIH) poses a significant clinical challenge in pediatric dentistry due to enamel fragility, hypersensitivity, and increased susceptibility to caries. While conventional resin-based fissure sealant (RBFS) is the gold standard fissure sealant material for occlusal caries, its performance on hypomineralized enamel remains suboptimal. Bioactive sealants are newly developed materials that promote remineralization and utilize both mechanical and chemical adhesion; however, they demonstrate poor retention when used with their self-etching primer. Bioactive sealants with phosphoric acid pre-etching may offer improved clinical outcomes for MIH-affected teeth. This study aims to evaluate and compare the clinical performance of pre-etched bioactive fissure sealants to conventional RBFS in permanent molars affected by MIH in terms of retention, marginal integrity, caries prevention effect, and sensitivity. Participants will be randomly allocated to receive either a bioactive sealant with phosphoric acid pre-etching or conventional RBFS. Clinical evaluations will be performed at 3-, 6-, and 12- months post-application using Modified United States Public Health Service (USPHS) criteria to assess retention, marginal adaptation, and secondary caries formation. Pre and postoperative sensitivity will be measured using the Schiff Cold Air Sensitivity Scale (SCASS).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
76

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Jordan
      • Irbid, Jordan
        • Jordan University of Science and Technology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 6-12-year-old patients with at least one fully erupted first permanent molar (FPM) diagnosed with MIH defects (White, creamy, or yellow to brownish opacities greater than one millimetre) without posteruptive enamel breakdown or caries (ICDAS code 0 or 1).
  • Non -contributory medical history
  • Children must exhibit sufficient cooperation for treatment.
  • FPMs status of eruption must allow for proper isolation. Exclusion Criteria:-
  • Medically compromised patient.- Partially erupted MIH first permanent molars that could not be sufficiently isolated.
  • Carious molars.
  • Restored MIH molars.
  • Sealed MIH molars.
  • MIH molars with extensive enamel breakdown that requires restoration.
  • MIH molars planned for extraction (compensatory or balancing extraction) as part of elective extraction plan of MIH molars with poor long-term prognosis.
  • Molars affected with other enamel defects ((e.g., amelogenesis imperfecta or fluorosis)
  • Non-MIH affected molars.
  • Parents did not consent for treatment.
  • Child not sufficiently cooperative for treatment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Pre-etched Bioactive Sealant
Bioactive fissure sealant applied after etching with phosphoric acid
Procedure: Pre-etched Bioactive Sealant
Application of the bioactive sealant after etching, washing, drying, and primer use.
Active Comparator: Resin-based fissure sealant
Resin-based fissure sealant is applied after etching with phosphoric acid
Procedure: Conventional Resin-based Sealant
Application of resin-based fissure sealant after etching, washing, drying and bonding.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Sealant retention
Time Frame: 3,6 and 12 months
Evaluation of sealant retention using the Modified United States Public Health Service (USPHS) criteria under good light source and using a dental mirror and a straight explorer
3,6 and 12 months
Marginal integrity
Time Frame: 3,6 and 12 months
Evaluation for the presence of fractures or gaps in the sealant-tooth interface using the Modified United States Public Health Service (USPHS) criteria under a good light source and using a dental mirror and straight explorer.
3,6 and 12 months
Marginal discoloration
Time Frame: 3,6 and 12 months
Evaluation for marginal discolouration using the Modified United States Public Health Service (USPHS) criteria under good light source and using a dental mirror
3,6 and 12 months
Secondary Caries
Time Frame: 3,6 and 12 months
Evaluation for new caries using the Modified United States Public Health Service (USPHS) criteria under a good light source and using a dental mirror and a straight explorer.
3,6 and 12 months
Anatomic form
Time Frame: 3,6 and 12 months
Evaluation of anatomic form using the modified United States of Public Health Service Criteria.
3,6 and 12 months
Surface Texture
Time Frame: 3,6 and 12 months
Evaluation for surface texture using the modified United States of Public Health Service Criteria
3,6 and 12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Sensitivity
Time Frame: Pre-operative, 3,6, and 12 months
Evaluation of pre-operative and post-operative sensitivity using the Schiff Cold Air Sensitivity Scale (SCASS).
Pre-operative, 3,6, and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jordan University of Science and Technology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 30, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 25, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 25, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 1, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 11, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 9, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 196-2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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