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

Clinical Evaluation of Resin Based Versus Giomer Fissure Sealants on MIH Affected Permanent Molars (RCT)

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07732790
Acronym
MIH RCT
Enrollment
22
Registered
2026-07-29
Start date
2025-06-29
Completion date
2026-07-10
Last updated
2026-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fissure Sealant, Molar Hypomineralization, Incisor, Resin Based Sealers

Keywords

MIH, resin based sealer, giomer based sealer, first permanent molar

Brief 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

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.

Sponsors

National Research Centre, Egypt
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
6 Years to 12 Years
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

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Evaluate the clinical success of giomer and conventional resin-based sealants applied on first permanent molars (FPMs) affected by MIH.12 months
number of tooth with failed fissure sealant12 monthsFissure 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.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 30, 2026