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

NCT07008599 | Completed

• 1 other identifier: MUPEDODENTSERAYSAHİN
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Molar-Incisor Hypomineralization (MIH); Tooth Hypersensitivity; Pediatric Dentistry; Pulpal Biomarkers

Outcome Measures

Primary Outcomes (1)

• Evaluation of biochemical mediators in pulpal blood samples using enzyme-linked immunosorbent assay (ELISA)

  Quantitative concentrations (pg/mL) of proinflammatory (TNF-α, IL-6, IL-8) and anti-inflammatory (IL-4, IL-10, IL-13) cytokines, as well as matrix metalloproteinases (MMP-3, MMP-8, MMP-9), measured using ELISA in pulpal blood.

  26.11.2024- 16.04.2025

Study Arms (6)

MIH Asymptomatic

OTHER

Pulp blood samples were collected during the procedure of vital pulp treatment

Other: Pulpal Blood Sample

MIH Reversible

OTHER

Pulp blood samples were collected during the procedure of vital pulp treatment

Other: Pulpal Blood Sample

MIH Irreversible

OTHER

Pulp blood samples were collected during the procedure of vital pulp treatment

Other: Pulpal Blood Sample

Control Asymptomatic

OTHER

Pulp blood samples were collected during the procedure of vital pulp treatment

Other: Pulpal Blood Sample

Control Reversible

OTHER

Pulp blood samples were collected during the procedure of vital pulp treatment

Other: Pulpal Blood Sample

Control Irreversible

OTHER

Pulp blood samples were collected during the procedure of vital pulp treatment

Other: Pulpal Blood Sample

Interventions

Pulpal Blood Sample OTHER

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

Control Asymptomatic; Control Irreversible; Control Reversible; MIH Asymptomatic; MIH Irreversible; MIH Reversible

Eligibility Criteria

• Age: 8 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children aged between 8 and 13 years who were cooperative (able to comply with instructions)
• Without any systemic diseases, syndromes, anomalies, or known allergies
• First permanent molars requiring pulp therapy were included in the study.

You may not qualify if:

• Patients who had used antibiotics within the last month
• Teeth deemed unrestorable
• Teeth showing lamina dura loss or pathological root resorption on radiographic examination
• Teeth that had previously undergone endodontic treatment
• Teeth with internal or external root resorption
• Teeth presenting with pus, necrosis, or exudate at the exposure site during treatment
• Teeth in which no pulp exposure occurred during the procedure

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara Üniversitesi Recep Tayyip Erdoğan Külliyesi Sağlık Yerleşkesi, Diş Hekimliği Fakültesi, Başıbüyük Yolu 9/3 34854 Başıbüyük / Maltepe / İSTANBUL

Istanbul, Beypazarı, 34854, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Molar Hypomineralization; Dental Pulp Diseases; Dentin Sensitivity

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 Officials

• Seray Şahin, Doctor of Dental Surgery (DDS)

  Marmara University, School of Dentistry, Department of Pediatric Dentistry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 29, 2025
• First Posted: June 6, 2025
• Study Start: March 4, 2024
• Primary Completion: November 26, 2024
• Study Completion: April 18, 2025
• Last Updated: December 15, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: De-identified individual participant data (IPD), along with supporting documents such as the study protocol and statistical analysis plan, will be available beginning 6 months after publication of the primary study results and will remain available for 5 years following the publication date.
• Access Criteria: Requests for access to de-identified individual participant data and supporting documents will be considered for academic or scientific research purposes. Interested researchers must submit a written proposal detailing the planned analysis, including objectives and statistical methods. Requests will be reviewed by the principal investigator and institutional review board (IRB) representatives to ensure ethical compliance and scientific merit. A data use agreement must be signed prior to data release. Requests can be submitted via email to the corresponding author listed in the publication.

Locations

TU (1)