Single Gene Polymorphisms Associated With Molar-Incisor Hypomineralization

NCT ID: NCT06165055

Last Updated: 2023-12-18

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-12-31

Study Completion Date

2025-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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. .

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Molar-Incisor Hypomineralization

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

MIH-affected participants (study group )

The Study Arm comprises individuals aged 8-13 with Molar-Incisor Hypomineralization (MIH) in at least one permanent molar.

DNA Sample Collection + DNA genotyping

Intervention Type DIAGNOSTIC_TEST

Volunteers' oral epithelial cell DNA will be collected using DNA swabs, followed by DNA isolation with the PureLink DNA Isolation Kit. The isolated DNA's quality will be assessed using the Invitrogen QUBIT 4 Fluorometer, and the samples will be stored at -20°C until analysis of specific genetic regions.

Systemically healthy controls (control group )

Systemically healthy individuals without MIH.

DNA Sample Collection + DNA genotyping

Intervention Type DIAGNOSTIC_TEST

Volunteers' oral epithelial cell DNA will be collected using DNA swabs, followed by DNA isolation with the PureLink DNA Isolation Kit. The isolated DNA's quality will be assessed using the Invitrogen QUBIT 4 Fluorometer, and the samples will be stored at -20°C until analysis of specific genetic regions.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

DNA Sample Collection + DNA genotyping

Volunteers' oral epithelial cell DNA will be collected using DNA swabs, followed by DNA isolation with the PureLink DNA Isolation Kit. The isolated DNA's quality will be assessed using the Invitrogen QUBIT 4 Fluorometer, and the samples will be stored at -20°C until analysis of specific genetic regions.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

8 Years

Maximum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Marmara University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Betul Sen Yavuz, DDS

Role: CONTACT

Phone: +905399887646

Email: [email protected]

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MarmaraPedo2

Identifier Type: -

Identifier Source: org_study_id