Single Gene Polymorphisms Associated With Molar-Incisor Hypomineralization

Not yet recruiting

• Conditions: Molar-Incisor Hypomineralization
• Interventions: Diagnostic Test: DNA Sample Collection + DNA genotyping

• Registration Number: NCT06165055
• Lead Sponsor: Marmara University

Brief Summary

The genetic factors associated with Molar-Incisor Hypomineralization (MIH), a dental condition affecting permanent molars in individuals aged 8-13. Buccal swab samples collected from 90 MIH-affected participants and 90 systemically healthy controls. The goal is to identify potential genetic markers contributing to the etiology of MIH, shedding light on previously unexplored aspects of genetic susceptibility.

Detailed Description

The aim of study is to elucidate the unknown aspects of genetic predisposition that may be effective in the etiology of Molar-Incisor Hypomineralization (MIH), that is, to identify unexplored genes that may be associated with MIH. The buccal swab method will be used for the purpose of collecting DNA samples.Samples will be collected from the inner cheek using a swab. The collected samples will be placed in single-use sterile Eppendorf tubes containing Phosphate Buffered Saline (PBS) solution. The samples will be stored at +4 degrees Celsius in a refrigerator, and DNA isolations will be performed within a few days. .

Study Timeline

• Status Verified: 2023-12
• Study Start: 2023-12
• Study First Submitted: 2023-12-01
• Study First Submitted QC: 2023-12-01
• Study First Posted: 2023-12-11
• Last Update Submitted: 2023-12-12
• Last Update Posted: 2023-12-18
• Primary Completion: 2024-12
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Patients aged between 8 and 13 years
• Patients whose parents consent to participate in the study
• Patients who provide cooperation for treatment and study
• For the study group: patients with at least one molar tooth showing molar-incisor hypomineralization
• For the control group: patients without molar-incisor hypomineralization
• Patients without a genetic disease in themselves or their family

Exclusion Criteria

• Patients with a genetic disease in themselves or their family

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
MIH-affected participants (study group )	DNA Sample Collection + DNA genotyping	The Study Arm comprises individuals aged 8-13 with Molar-Incisor Hypomineralization (MIH) in at least one permanent molar.
Systemically healthy controls (control group )	DNA Sample Collection + DNA genotyping	Systemically healthy individuals without MIH.

Primary Outcome Measures

Name	Time	Method
genotyping of polymorphisms	1.5 -2 year	The genotyping of polymorphisms will be conducted using the StepOnePlus instrument (Thermo Fisher Scientific, Inc.) through Real-Time PCR, following the manufacturers' protocols (cat. no. 4371355, Thermo Fisher Scientific, Inc.) and utilizing Taqman SNP genotyping kits. The reaction volume will be 10 µl in total, comprising 5 µl of Genotyping Master Mix (Applied Biosystems, Foster City, CA), 3.5 µl of nuclease-free H2O (Thermofisher, USA), 0.5 µl of genotyping assay (Applied Biosystems), and 1 µl of DNA.