Clinical Efficacies of Different Agents in Molar-Incisor Hypomineralization

NCT06180369 | Unknown

• 1 other identifier: MarmaraPedo3
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Molar-Incisor Hypomineralization

Outcome Measures

Primary Outcomes (2)

• The Schiff Cold Air Sensitivity Score

  The Schiff Cold Air Sensitivity Score is a test conducted in dental units. Cold air from a spray is applied to the surface of the tooth's dentin, 2-3 mm away, and at a 90-degree angle, with continuous pressure of 45-60 PSI for 2-3 seconds, following the isolation of neighboring teeth. The temperature should be around 20 degrees Celsius. The patient's pain level is then scored by the dentist using a scale. * Score 0: No response to the stimulus. * Score 1: Responds to the stimulus but does not request it to be stopped. * Score 2: Responds to the stimulus, requests it to be stopped, or makes movements to avoid it. * Score 3: Responds to the stimulus, finds it painful, and requests it to be stopped.

  1.5 -2 year

• Parent Satisfaction

  Parent Satisfaction: To assess parental satisfaction regarding the applied restoration, a Likert-type scale will be used to score crowns based on their appearance, color, shape, size, and overall aesthetic (Suguna and Gurunathan, 2021). 1. Not satisfied at all 2. Not satisfied 3. Neither satisfied nor dissatisfied (Neutral) 4. Satisfied 5. Very satisfied

  1.5-2 year

Study Arms (2)

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

OTHER

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

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

BeutiSealant (Shofu, Kyoto, Japonya)

OTHER

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

Other: BeutiSealant (Shofu, Kyoto, Japonya)

Interventions

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

Fissur Sealent application

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

BeutiSealant (Shofu, Kyoto, Japonya) OTHER

Fissur Sealent application

BeutiSealant (Shofu, Kyoto, Japonya)

Eligibility Criteria

• Age: 8 Years - 13 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Marmara University: lead

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

Central Study Contacts

Betül Sen Yavuz, DDS

CONTACT

+905399887646; dt.betulsen@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2023
• First Posted: December 22, 2023
• Study Start: December 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: May 1, 2025
• Last Updated: December 22, 2023

Record last verified: 2023-12