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

NCT07732790 | Completed DMC

• 1 other identifier: 0345
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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

Conditions

Fissure Sealant; Resin Based Sealers; Molar Hypomineralization, Incisor

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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 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.

  12 months

Study Arms (2)

Fisseal, Resin based fissure sealant

ACTIVE COMPARATOR

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)

Beautisealant, Giomer based fissure sealant

ACTIVE COMPARATOR

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

Resin based fissure sealant (Fisseal) OTHER

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

Beautisealant, Giomer based fissure sealant

Giomer based fissure sealant ( Beautisealant) OTHER

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.

Fisseal, Resin based fissure sealant

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Research Centre, Egypt: lead

Study Sites (1)

National Research Centre

Cairo, Giza Governorate, 12572, Egypt

Location

MeSH Terms

Conditions

Molar Hypomineralization

Condition Hierarchy (Ancestors)

Dental Enamel Hypomineralization; Developmental Defects of Enamel; Tooth Abnormalities; Stomatognathic System Abnormalities; Stomatognathic Diseases; Tooth Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher of pediatric dentistry

Study Record Dates

• First Submitted: July 12, 2026
• First Posted: July 29, 2026
• Study Start: June 29, 2025
• Primary Completion: June 29, 2026
• Study Completion: July 10, 2026
• Last Updated: July 29, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)