Clinical Efficacies of Different Agents in Molar-Incisor Hypomineralization

Evaluation of Clinical Efficacies of Different Agents in Molar-Incisor Hypomineralization-Affected Molars

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Molar-Incisor Hypomineralization
• Intervention / Treatment: Other: GC Fuji Triage ® GC America Inc., Alsip, Illinois ); Other: BeutiSealant (Shofu, Kyoto, Japonya)

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Betül Sen Yavuz, DDS; Phone Number: +905399887646; Email: dt.betulsen@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: GC Fuji Triage ® GC America Inc., Alsip, Illinois ); Fissure sealant application with GC Fuji Triage (GC America Inc., Alsip, Illinois )	Other: GC Fuji Triage ® GC America Inc., Alsip, Illinois ); Fissur Sealent application
Other: BeutiSealant (Shofu, Kyoto, Japonya); Fissure sealant application with BeutiSealant (Shofu, Kyoto, Japonya)	Other: BeutiSealant (Shofu, Kyoto, Japonya); Fissur Sealent application

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).; Not satisfied at all; Not satisfied; Neither satisfied nor dissatisfied (Neutral); Satisfied; Very satisfied	1.5-2 year

Collaborators and Investigators

• Sponsor: Marmara University

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2023
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): May 1, 2025

Study Registration Dates

• First Submitted: December 1, 2023
• First Submitted That Met QC Criteria: December 12, 2023
• First Posted (Actual): December 22, 2023

Study Record Updates

• Last Update Posted (Actual): December 22, 2023
• Last Update Submitted That Met QC Criteria: December 12, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities; Stomatognathic Diseases; Tooth Diseases; Stomatognathic System Abnormalities; Tooth Abnormalities; Dental Enamel Hypomineralization; Developmental Defects of Enamel; Dental Enamel Hypoplasia; Molar Hypomineralization
• Other Study ID Numbers: MarmaraPedo3

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No