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

NCT06922552 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2025-04-16

No results posted yet for this 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?

Conditions

  • Molar Incisor Hypomineralization

Interventions

PROCEDURE

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.

PROCEDURE

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.

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-30
Primary Completion
2026-02-28
Completion
2026-06-30

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06922552 on ClinicalTrials.gov