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

March 25, 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

Enrolling by invitation

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Estimated)

76

Phase

  • 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

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
Intervention / Treatment
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

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

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

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)

August 1, 2025

Primary Completion (Estimated)

August 30, 2027

Study Completion (Estimated)

August 30, 2027

Study Registration Dates

First Submitted

March 25, 2026

First Submitted That Met QC Criteria

March 25, 2026

First Posted (Actual)

April 1, 2026

Study Record Updates

Last Update Posted (Actual)

April 1, 2026

Last Update Submitted That Met QC Criteria

March 25, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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