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Enrolling by invitation NCT07504614

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

No phase Interventional Molar Incisor Hypomineralization Fissure Sealant

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Pre-etched Bioactive Sealant, Conventional Resin-based Sealant.
Who it may be relevant to
Registry conditions: Molar Incisor Hypomineralization, Fissure Sealant. Basic parameters: 6 years — 12 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Jordan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

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).

Interventions

  • Procedure Pre-etched Bioactive Sealant
    Application of the bioactive sealant after etching, washing, drying, and primer use.
  • Procedure Conventional Resin-based Sealant
    Application of resin-based fissure sealant after etching, washing, drying and bonding.

Primary outcome measures

  • Sealant retention [Time frame: 3,6 and 12 months]
  • Marginal integrity [Time frame: 3,6 and 12 months]
  • Marginal discoloration [Time frame: 3,6 and 12 months]
  • Secondary Caries [Time frame: 3,6 and 12 months]
  • Anatomic form [Time frame: 3,6 and 12 months]
  • Surface Texture [Time frame: 3,6 and 12 months]
Secondary outcome measures (1)
  • Sensitivity [Time frame: Pre-operative, 3,6, and 12 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Prevention

Study locations

Jordan · 1 center
  • Jordan University of Science and Technology — Irbid

Identifiers

NCT: NCT07504614 · 196-2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗