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Clinical Efficacies of Different Agents in Molar-Incisor Hypomineralization

NCT ID: NCT06180369

Last Updated: 2023-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-31

Study Completion Date

2025-05-31

Brief Summary

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This study aims to assess the clinical effectiveness of GC Fuji Triage ® (GC America Inc., Alsip, Illinois) and BeutiSealant (Shofu, Kyoto, Japan) in children aged 8-13 with multiple molars affected by Molar-Incisor Hypomineralization (MIH). The comparison focuses on permanent first molars affected by MIH.

Detailed Description

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The study targets children within the specified age range with MIH-affected molars, comparing the clinical outcomes of GC Fuji Triage and BeutiSealant. The assessment will provide valuable insights into the efficacy of these agents in managing severe hypomineralization, contributing to our understanding of effective treatment modalities for MIH.

The evaluation criteria include restoration success, prevention of further decay development, prevention of post-eruption breakdown, alleviation of tooth sensitivity, and measurement of life quality. These criteria will be compared with those of Resin Fissure Sealant.

Conditions

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Molar-Incisor Hypomineralization

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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GC Fuji Triage ® GC America Inc., Alsip, Illinois )

Fissure sealant application with GC Fuji Triage (GC America Inc., Alsip, Illinois )

Group Type OTHER

GC Fuji Triage ® GC America Inc., Alsip, Illinois )

Intervention Type OTHER

Fissur Sealent application

BeutiSealant (Shofu, Kyoto, Japonya)

Fissure sealant application with BeutiSealant (Shofu, Kyoto, Japonya)

Group Type OTHER

BeutiSealant (Shofu, Kyoto, Japonya)

Intervention Type OTHER

Fissur Sealent application

Interventions

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GC Fuji Triage ® GC America Inc., Alsip, Illinois )

Fissur Sealent application

Intervention Type OTHER

BeutiSealant (Shofu, Kyoto, Japonya)

Fissur Sealent application

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Healthy children aged 8-13 with hypomineralization in their first permanent molars.
* Children without systemic diseases or developmental dental anomalies that could affect hypomineralization.
* Those with at least two molars exhibiting molar-incisor hypomineralization (MIH), specifically scoring 1 and 3 according to the MIH-Tll index.
* Children with a positive or 'definitely positive' cooperation according to the Frankl Behavior Rating Scale (Frankl et al., 1962).
* Absence of spontaneous pain, abscess, mobility, or inter-radicular lesions in the tooth to be treated.
* Patients or their parents consenting to participate in the treatment.

Exclusion Criteria

* Children with systemic diseases or developmental dental anomalies that could affect hypomineralization.
* To have MIH outside the specified scores.
* Children unable to continue treatment in the chair due to cooperation problems.
* Failure to attend control sessions or a desire not to continue with the study.
* Patients and their parents unwilling to participate in the treatment.
* If the patient cannot attend control sessions or disrupts sessions, they will be withdrawn from the study.
Minimum Eligible Age

8 Years

Maximum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Marmara University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Betül Sen Yavuz, DDS

Role: CONTACT

Phone: +905399887646

Email: [email protected]

Other Identifiers

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MarmaraPedo3

Identifier Type: -

Identifier Source: org_study_id