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Assessment of Inflammatory Biomarkers in Molar-Incisor Hypomineralization-Affected First Permanent Molars

NCT07008599 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 83

Last updated 2025-12-15

No results posted yet for this study

Summary

Molar-Incisor Hypomineralization (MIH) is a qualitative developmental defect of enamel primarily affecting the permanent first molars and often incisors. The global prevalence of MIH ranges from 2.9% to 44%. Although the precise etiology of MIH remains unclear, it is considered multifactorial, involving interactions between genetic, environmental, and systemic factors during the prenatal, perinatal, and postnatal periods. Environmental toxins such as Bisphenol A (BPA) have also been implicated in its development. Despite the well-documented impact of MIH on enamel and dentin, little is known about the inflammatory changes in the pulp tissue of these teeth. This controlled clinical study aims to assess the levels of proinflammatory and anti-inflammatory cytokines in the pulp tissues of first permanent molars affected by MIH and compare them with those in non-MIH teeth. The null hypothesis is that there is no statistically significant difference in the levels of these cytokines between MIH-affected and non-affected pulp tissues. The findings are expected to contribute valuable insights into the pathophysiology of MIH-related pulpal involvement and support the development of improved diagnostic and therapeutic strategies. Pulpal blood samples were obtained from 85 first permanent molars of systemically healthy children aged 8 to 13 who underwent pulp therapy. Based on the presence or absence of Molar-Incisor Hypomineralization (MIH), teeth were assigned to either the MIH group or the control group. To evaluate the dental status and detect possible signs of pulpitis, the MIH-TNI index, Schiff sensitivity scale, Periapical Index (PAI), cold test responses, and other clinical parameters were recorded.

Conditions

  • Molar-Incisor Hypomineralization (MIH)
  • Pulp Disease, Dental
  • Inflamation

Interventions

OTHER

Pulpal Blood Sample

Biochemical markers were measured in blood samples using enzyme-linked immunosorbent assay (ELISA).

Sponsors & Collaborators

  • Marmara University

    lead OTHER

Principal Investigators

  • Seray Şahin, Doctor of Dental Surgery (DDS) · Marmara University, School of Dentistry, Department of Pediatric Dentistry

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
13 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-04
Primary Completion
2024-11-26
Completion
2025-04-18

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07008599 on ClinicalTrials.gov