NCT07504614

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
13mo left

Started Aug 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress48%
Aug 2025Aug 2027

Study Start

First participant enrolled

August 1, 2025

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 25, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 1, 2026

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2027

Last Updated

April 1, 2026

Status Verified

March 1, 2026

Enrollment Period

2.1 years

First QC Date

March 25, 2026

Last Update Submit

March 25, 2026

Conditions

Molar Incisor HypomineralizationFissure Sealant

Keywords

Molar Incisor HypomineralizationFissure sealantChildrenBioactive Dental material

Outcome Measures

Primary Outcomes (6)

  • Sealant retention

    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

    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

    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

    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

    Evaluation of anatomic form using the modified United States of Public Health Service Criteria.

    3,6 and 12 months

  • Surface Texture

    Evaluation for surface texture using the modified United States of Public Health Service Criteria

    3,6 and 12 months

Secondary Outcomes (1)

  • Sensitivity

    Pre-operative, 3,6, and 12 months

Study Arms (2)

Pre-etched Bioactive Sealant

EXPERIMENTAL

Bioactive fissure sealant applied after etching with phosphoric acid

Procedure: Pre-etched Bioactive Sealant

Resin-based fissure sealant

ACTIVE COMPARATOR

Resin-based fissure sealant is applied after etching with phosphoric acid

Procedure: Conventional Resin-based Sealant

Interventions

Pre-etched Bioactive SealantPROCEDURE

Application of the bioactive sealant after etching, washing, drying, and primer use.

Pre-etched Bioactive Sealant
Conventional Resin-based SealantPROCEDURE

Application of resin-based fissure sealant after etching, washing, drying and bonding.

Resin-based fissure sealant

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jordan University of Science and Technology

Irbid, Jordan

Location

MeSH Terms

Conditions

Molar Hypomineralization

Condition Hierarchy (Ancestors)

Dental Enamel HypomineralizationDevelopmental Defects of EnamelTooth AbnormalitiesStomatognathic System AbnormalitiesStomatognathic DiseasesTooth DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2026

First Posted

April 1, 2026

Study Start

August 1, 2025

Primary Completion (Estimated)

August 30, 2027

Study Completion (Estimated)

August 30, 2027

Last Updated

April 1, 2026

Record last verified: 2026-03

Locations

JO(1)