Molar-Incisor Hypomineralization Vs Periodontal Health

Completed

• Conditions: Molar-Incisor Hypomineralization; Peridontal Disease

• Registration Number: NCT06764043
• Lead Sponsor: Recep Tayyip Erdogan University Training and Research Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-01
• Primary Completion: 2024-05-01
• Study Completion: 2024-09-01
• Study First Submitted: 2024-12-24
• Status Verified: 2025-01
• Study First Submitted QC: 2025-01-02
• Last Update Submitted: 2025-01-02
• Study First Posted: 2025-01-08
• Last Update Posted: 2025-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Periodontal indexes measurement	1 day	PI, GI, and PPD measurements were performed to evaluate the periodontal health of the children participating in the study.
GCF measurement	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	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.

Trial Locations

Locations (1)

Recep Tayyip Erdoğan University Faculty of Dentistry; 🇹🇷 Rize, Turkey