Molar-Incisor Hypomineralization Vs Periodontal Health

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.

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Key information

Conditions

Molar-Incisor Hypomineralization Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dental Enamel Hypomineralization Developmental Defects of Enamel Molar Hypomineralization Peridontal Disease Stomatognathic Diseases Stomatognathic System Abnormalities Tooth Abnormalities Tooth Diseases

Age range

8 year–14 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Recep Tayyip Erdoğan University Faculty of Dentistry

Rize, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Clinical evaluation

Other

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.

Primary outcomes

Periodontal indexes measurement

Time frame: 1 day

PI, GI, and PPD measurements were performed to evaluate the periodontal health of the children participating in the study.
GCF measurement

Time frame: 1 day

In 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 Method

Time frame: for three days from the beginning of the study

The 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.

Sponsors and collaborators

Lead sponsor

Recep Tayyip Erdogan University Training and Research Hospital

Other

Registry information

Official study title

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

Acronym: MIH

Important dates

Study start: 2023
Primary completion: 2024
Study completion: 2024
First posted: Jan 8, 2025
Registry last updated: Jan 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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