Molar-Incisor Hypomineralization Vs Periodontal Health

NCT06764043 | Completed DMC

• 2 other identifiers: 2023/1211495
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Molar-Incisor Hypomineralization; Peridontal Disease

Keywords

Gingival crevicular fluid; Matrix metalloproteinase 8; Matrix metalloproteinase 20

Outcome Measures

Primary Outcomes (3)

• Periodontal indexes measurement

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

  1 day

• GCF measurement

  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.

  1 day

• Evaluation of MMP-8, MMP-20 and TGF-β1 Levels by ELISA Method

  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.

  for three days from the beginning of the study

Interventions

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.

Eligibility Criteria

• Age: 8 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Pediatric population with MIH

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Recep Tayyip Erdogan University Training and Research Hospital: lead

Study Sites (1)

Recep Tayyip Erdoğan University Faculty of Dentistry

Rize, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 40676550 DERIVED

MeSH Terms

Conditions

Molar Hypomineralization

Condition Hierarchy (Ancestors)

Dental Enamel Hypomineralization; Developmental Defects of Enamel; Tooth Abnormalities; Stomatognathic System Abnormalities; Stomatognathic Diseases; Tooth Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc.Prof.

Study Record Dates

• First Submitted: December 24, 2024
• First Posted: January 8, 2025
• Study Start: January 1, 2023
• Primary Completion: May 1, 2024
• Study Completion: September 1, 2024
• Last Updated: January 8, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)