Molar-Incisor Hypomineralization Vs Periodontal Health

NCT ID: NCT06764043

Last Updated: 2025-01-08

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

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Recruitment Status

COMPLETED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-01

Study Completion Date

2024-09-01

Brief Summary

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Background: To investigate the effect of molar incisor hypomineralization (MIH) on periodontal health, to evaluate the relationship between gingival crevicular fluid (GCF) volume, and GCF biomarkers such as matrix metalloproteinase-8 (MMP-8), matrix metalloproteinase-20 (MMP-20), and transforming growth factor-beta 1 (TGF-β1), and MIH.

Methods: The study was conducted on 40 pediatric patients diagnosed with MIH (Study Group/SG), and 40 pediatric patients healthy for MIH (Control Group/CG). Clinical periodontal measurements (plaque index (PI), gingival index (GI), probing pocket depth (PPD), and GCF volume were performed. Concentrations of MMP-8, MMP-20, and TGF-β1 in GCF were determined using enzyme-linked immunosorbent assay (ELISA). Mann-Whitney U test and T-test were used for comparisons between groups. Significance was set at p=0.05 for statistical analysis.

Detailed Description

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Conditions

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Molar-Incisor Hypomineralization Peridontal Disease

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

CROSS_SECTIONAL

Interventions

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Clinical evaluation

In this study, it was aimed to measure the levels of MMP-8, MMP-20, and TGF-β1 in GCF together with the volume of GCF to investigate the effect of MIH on oral hygiene, and gingival health, and also to evaluate the relationship between MIH, and various biomarkers.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* the ages of 8 and 14 who were diagnosed with MIH in their maxillary permanent first molars,
* had healthy maxillary permanent first molars,
* scored 3 (positive) or 4 (definitely positive) on the Frankl Behavior Scale,
* had no mental or physical disability,
* did not need urgent treatment and/or were not in pain,
* agreed to participate in the study with their parents and signed the consent form.

Exclusion Criteria

* Children with systemic, chronic, and/ or metabolic diseases,
* under active orthodontic treatment, with developmental defects of enamel (excluding MIH), or born prematurely
Minimum Eligible Age

8 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Recep Tayyip Erdogan University Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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DİLARA NİL GÜNAÇAR

Assoc.Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Recep Tayyip Erdoğan University Faculty of Dentistry

Rize, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Bilgir BS, Aydinoglu S, Arslan I, Atak M, Kose O, Gunacar DN. Analysis of MMP-8, MMP-20, and TGF-beta1 in molar-incisor hypomineralization and assessment of periodontal health. BMC Oral Health. 2025 Jul 17;25(1):1189. doi: 10.1186/s12903-025-06551-9.

Reference Type DERIVED
PMID: 40676550 (View on PubMed)

Other Identifiers

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1495

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2023/121

Identifier Type: -

Identifier Source: org_study_id

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