CClinicalTrials.gg
CompletedNCT07732790MIH RCTUpdated Jul 29, 2026

Clinical Evaluation of Two Fissure Sealants (Resin Based Versus Giomer Fissure Sealants) on Molar Incisor Hypominerlisation Affected Permanent Molars (RCT)

An interventional study of Resin based fissure sealant (Fisseal) and Giomer based fissure sealant ( Beautisealant) in Molar Hypomineralization, Incisor, Fissure Sealant and Resin Based Sealers, sponsored by National Research Centre, Egypt. Completed at 1 site in Egypt. Open to participants aged 6 Years to 12 Years. Per ClinicalTrials.gov, last updated 2026-07-29.

Sponsored by National Research Centre, Egypt · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year after the study started (first participant enrolled Jun 2025, registered Jul 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
22
Allocation
Randomized
Ages
6 Years to 12 Years
Sex
All
01

Study summary

This study aims to compare the effect of two types of fissure sealant a resin based and giomer based in molar incisor hypominerlisation first permanent molars

02

Conditions studied

  • Molar Hypomineralization, Incisor
  • Fissure Sealant
  • Resin Based Sealers

Keywords

  • MIH
  • resin based sealer
  • giomer based sealer
  • first permanent molar
03

In context

Molar Hypomineralization

121 studies on the registry are indexed under Molar Hypomineralization; 41 are open to participants now.

This study's enrollment of 22 is below the median of 52 across 94 interventional studies indexed under Molar Hypomineralization.

Browse Molar Hypomineralization studies →

Lead sponsor

National Research Centre, Egypt is the lead sponsor of 49 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

    • Apparently Healthy Children aged 6-12 years having at least one fully erupted First Permanent Molar (FPM) with MIH indicated for non-invasive fissure sealant.

      • Cooperative children.
      • Occlusal mild MIH defects (demarcated white, yellow or brown lesions)
      • sound surfaces and no incipient enamel caries, where moist control can be achieved.

Exclusion criteria

Exclusion Criteria:

  • Children having hypomineralized FPMs with post eruption breakdown (PEB).
  • Cavitated carious lesions.
  • Restorations, fixed orthodontic appliances.
  • Enamel defect(s) due to a condition other than MIH.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
22 participants (actual)

Study arms

  • Active comparator
    Fisseal, Resin based fissure sealant

    Fisseal is a light-curing, fluoride-releasing pit and fissure sealant. the occlusal surfaces will be etched with 37% phosphoric acid for 30 seconds, rinsed with air-water spray for 30 s and dried with air for 15 s. resin sealant (Fisseal) then applied into the occlusal fissures and light-cured for 20 s.

    Other: Giomer based fissure sealant ( Beautisealant)

  • Active comparator
    Beautisealant, Giomer based fissure sealant

    Beautisealant is a fluoride-releasing pit and fissure sealant that features Giomer technology. the self-etch primer (BeautiSealant Primer) will be applied to the occlusal fissures with a fine micro brush. After waiting for 5 s, and homogenizing the bond layer with gentle air stream for 5 s, the giomer sealant (BeautiSealant Paste) will be placed and light-cured for 20 s.

    Other: Resin based fissure sealant (Fisseal)

Interventions

  • OtherResin based fissure sealant (Fisseal)

    Fisseal is a light-curing, fluoride-releasing pit and fissure sealant. composition: Methacrylate Monomers, Inorganic Fillers, Photoinitiator System and Sodium Fluoride.

  • OtherGiomer based fissure sealant ( Beautisealant)

    BeautiSealant is a fluoride-releasing pit and fissure sealant that features Giomer technology. it's BPA- and HEMA-free pit and fissure sealant. it's composition: S-PRG (Surface Pre-Reacted Glass) Fillers, UDMA (Urethane Dimethacrylate), TEGDMA (Triethylene Glycol Dimethacrylate), Micro Fumed Silica.

06

What researchers measure

Primary outcomes

  1. Evaluate the clinical success of giomer and conventional resin-based sealants applied on first permanent molars (FPMs) affected by MIH.

    Time frame: 12 months

  2. number of tooth with failed fissure sealant

    Fissure sealants will be checked under artificial light with a dental mirror and straight explorer. The sealants that will receive "Alpha" or "Bravo" scores from all of the USPHS Criteria (anatomic form, marginal adaptation, surface texture, marginal discoloration, retention and secondary caries) will be classified as successful. On the other hand, "Charlie" score from one or more of the USPHS criteria will be considered as a failure.

    Time frame: 12 months

07

Study locations

1 site
  • National Research Centre
    Cairo, Giza Governorate 12572, Egypt
08

References and documents

Study documents

  • Study protocol · Jun 29, 2025
  • Informed consent form · Jun 29, 2025

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 29, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07732790
Lead sponsor
National Research Centre, Egypt
Responsible party
Rabab Mahmoud Abd Elhakam (Researcher of pediatric dentistry, National Research Centre, Egypt) — Principal investigator
First posted
Jul 29, 2026
Start date
Jun 29, 2025
Primary completion
Jun 29, 2026
Completion
Jul 10, 2026
Last update
Jul 29, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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