Clinical Efficacies of Different Agents in Molar-Incisor Hypomineralization

Marmara University

Status: Not yet enrolling

Conditions: Molar-Incisor Hypomineralization

Treatments: Other: GC Fuji Triage ® GC America Inc., Alsip, Illinois ); Other: BeutiSealant (Shofu, Kyoto, Japonya)

Study type: Interventional

Funder types: Other

Identifiers

NCT06180369

MarmaraPedo3

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 8 to 13 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

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

Other group

Description:

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

Treatment:

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

BeutiSealant (Shofu, Kyoto, Japonya)

Other group

Description:

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

Treatment:

Other: BeutiSealant (Shofu, Kyoto, Japonya)