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Molar-Incisor Hypomineralization Vs Periodontal Health

Molar-Incisor Hypomineralization (MIH) Vs Periodontal Health: Evaluation of Clinical Periodontal Indexes and Biomarkers (MMP-8, MMP-20 and TGF- Β1)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06764043
Acronym
MIH
Enrollment
80
Registered
2025-01-08
Start date
2023-01-01
Completion date
2024-09-01
Last updated
2025-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Molar-Incisor Hypomineralization, Peridontal Disease

Keywords

Gingival crevicular fluid, Matrix metalloproteinase 8, Matrix metalloproteinase 20

Brief summary

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.

Interventions

OTHERClinical 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.

Sponsors

Recep Tayyip Erdogan University Training and Research Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CROSSOVER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
8 Years to 14 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Periodontal indexes measurement1 dayPI, GI, and PPD measurements were performed to evaluate the periodontal health of the children participating in the study.
GCF measurement1 dayIn the study, GCF was collected in the morning hours (between 09:00 and 11:00) one day after the patient's clinical periodontal measurements were complete.
Evaluation of MMP-8, MMP-20 and TGF-β1 Levels by ELISA Methodfor three days from the beginning of the studyThe levels of MMP-8 (Elabscience® EL-H1450, Biotechnology Co., Ltd, Wuhan, China), MMP-20 (Bioassay Technology Laboratory, Cat. No E4139Hu), and TGF-β1 (Elabscience® EL-H0110, Biotechnology Co., Ltd, Wuhan, China) in GCF samples were measured using ELISA kits.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026