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Clinical Trials in Egypt / NCT06922552
Starting soon Not applicable

Clinical Performance of Giomer Preceded by Etching Versus Resin-Based Sealants Applied on Permanent Molars Affected by Molar-Incisor Hypo-mineralization

NCT06922552 · tracked via the Priya Life Science Egypt tracker
Phase
Not applicable
Started
2025-06
Last updated
2025-04-16

Condition(s) studied

Molar Incisor Hypomineralization

Investigational drug(s) / intervention(s)

Giomer pit and fissure sealant with etching applied on Permanent Molars Affected by MIHResin based sealant applied on Permanent Molars Affected by MIH

Giomer pit and fissure sealant with etching applied on Permanent Molars Affected by MIH: * Cleaning with a bristle brush and a non-fluoridated paste will be operated by a slow speed handpiece and absolute isolation (using rubber dam and Young's bow). * Phosphoric acid etch will be applied to the occlusal fissures for 30 seconds. Teeth will be washed using air-water spray for 30 seconds then drying using air for 15 seconds. Proper etching will be confirmed by a dull frosty-white appearance of the enamel An adequate amount of primer will be dispensed on the enamel surface of the pit and fissure using a brush then will be left undisturbed for 5sec. Gentle air blow for 3 sec and then dryness with stronger stream of air until a thin and uniform bonding layer is obtained. * The giomer sealant (BeautiSealant, Shofu, Kyoto, Japan) will be applied into the occlusal fissures applied Using the syringe needle tip and a brush into the pits and fissures. Stirring the sealant with the syringe-tip during or after placement will help eliminate any possible bubbles and enhance the flow.

Resin based sealant applied on Permanent Molars Affected by MIH: Cleaning with a bristle brush and a non-fluoridated paste will be operated by a slow speed handpiece and absolute isolation (using rubber dam and Young's bow). * Phosphoric acid etch will be applied to the occlusal fissures for 30 seconds. Teeth will be washed using air-water spray for 30 seconds then drying using air for 15 seconds. Proper etching will be confirmed by a dull frosty-white appearance of the enamel * The resin sealant (UltraSeal XT™ hydro™) will be applied Using the syringe needle tip and a brush into the pits and fissures. Stirring the sealant with the syringe-tip during or after placement will help eliminate any possible bubbles and enhance the flow into the pit and fissures. Photo - curing for the sealant will be done for 20 seconds using LED light curing unit. The tip of the light will be held as close as possible to the sealant, without actually touching the sealant. the surfaces will be checked with an explorer to ensure that no voids were present.

Study summary

The goal of the study is to evaluate the clinical performance of giomer sealant preceded by etching versus resin-based sealants applied on first permanent molars affected by molar incisor hypomineralization (MIH)

The main question it aims to answer is :

Will the use of Giomer (Beautisealant, Shofu, Kyoto, Japan) Preceded by Etching result in similar clinical performance as Resin-Based Sealants(UltraSeal XT™ Plus™ by Ultradent) Applied on Permanent Molars Affected by Molar-Incisor Hypomineralization?

Eligibility

Sex
ALL
Min age
6 Years
Max age
14 Years
Healthy volunteers
No
Inclusion Criteria: * Healthy children aged 6-14 years who are diagnosed with mild (MIH) according to European Academy of Pediatric Dentistry (EAPD) criteria which includes demarcated enamel opacities (white, creamy, or yellow to brownish), that may induce sensitivity to external stimuli without enamel breakdown. * Cooperative children. * Presenting at least one first permanent molar (FPMs) that were fully erupted and indicated for non-invasive fissure sealant. * Medically fit Children (ASA I). Exclusion Criteria: * Children have hypomineralized (FPMs) with post-eruptive breakdown, cavitated and non-cavitated carious lesions, restorations, or fixed orthodontic appliances. * Enamel defects due to a condition other than (MIH). * Parents are not willing to join. * Molars that cannot be isolated using rubber dam. * Uncooperative children. * Medically unfit children (other than ASA I).

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Cairo University Cairo Egypt

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06922552 on ClinicalTrials.gov ↗ ← All trials in Egypt