Assessment of Peridontal Inflamatuar Markers in MIH

NCT07701642 | Not Yet Recruiting

• 1 other identifier: Marmarapedoseymatez
• Study Type: observational
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to investigate periodontal inflammatory mediators in systemically healthy children aged 8-13 years with and without molar-incisor hypomineralization (MIH) who require initial periodontal treatment due to gingivitis. The main questions it aims to answer are: Are the levels of periodontal inflammatory mediators in gingival crevicular fluid different between children with MIH and those without MIH? Is the presence and severity of MIH associated with clinical periodontal parameters and dentin hypersensitivity? Researchers will compare children with MIH to children without MIH to determine whether MIH is associated with changes in periodontal inflammatory mediator levels and periodontal clinical findings.

Conditions

Molar-Incisor Hypomineralization (MIH)

Keywords

periodontal inflammatory markers; first permenant molars

Outcome Measures

Primary Outcomes (3)

• Concentration of proinflammatory and anti-inflammatory cytokines in gingival crevicular fluid

  Quantitative concentrations (pg/mL) of IL-1α, IL-1β, IL-6, IL-8, TNF-α, IFN-γ and IL-4, IL-10, IL-13, TGF-β1 measured in gingival crevicular fluid using enzyme-linked immunosorbent assay (ELISA).

  Baseline, 1 month after initial periodontal therapy, and 3 months after initial periodontal therapy

• Concentration of matrix metalloproteinases in gingival crevicular fluid

  Quantitative concentrations (pg/mL) of MMP-2, MMP-3, MMP-8, MMP-9, MMP-20, and TIMP-1 measured in gingival crevicular fluid using ELISA. Measurements will be obtained at baseline (before initial periodontal therapy) and after completion of initial periodontal therapy.

  Baseline, 1 month after initial periodontal therapy, and 3 months after initial periodontal therapy

• Total oxidant status and total antioxidant status in gingival crevicular fluid

  Total Oxidant Status (TOS) and Total Antioxidant Status (TAS) measured by spectrophotometric analysis at baseline (before initial periodontal therapy) and after completion of initial periodontal therapy.

  Baseline, 1 month after initial periodontal therapy, and 3 months after initial periodontal therapy

Study Arms (2)

MIH patients requiring initial periodontal treatment

Procedure: Initial periodontal treatment

Patients without MIH requiring initial periodontal treatment

Procedure: Initial periodontal treatment

Interventions

Initial periodontal treatment PROCEDURE

DOS samples will be taken before and after treatment

MIH patients requiring initial periodontal treatment; Patients without MIH requiring initial periodontal treatment

Eligibility Criteria

• Age: 8 Years - 13 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Systemically healthy children aged 8-13 years with gingivitis requiring initial periodontal therapy. The study includes children with molar-incisor hypomineralization (MIH) affecting at least three permanent first molars (study group) and age-matched children without MIH (control group).

You may qualify if:

• Systemically healthy children aged 8-13 years (both sexes).
• Children who demonstrate adequate cooperation for dental treatment and study procedures (Frankl Behavior Rating Scale score ≥3).
• Study group: Children with molar-incisor hypomineralization (MIH) affecting at least three permanent first molars and requiring initial periodontal treatment for gingivitis.
• Control group: Children without molar-incisor hypomineralization who require initial periodontal treatment for gingivitis.
• Presence of gingivitis requiring initial periodontal therapy.

You may not qualify if:

• Use of antibiotics within the previous 1 month.
• Radiographic evidence of periodontal destruction.
• History of periodontal treatment within the previous 3 months.
• Presence of systemic, chronic, or metabolic diseases.
• Ongoing active orthodontic treatment.
• Developmental enamel defects other than molar-incisor hypomineralization.
• History of premature birth.

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara Üniversitesi Recep Tayyip Erdoğan Külliyesi Sağlık Yerleşkesi, Diş Hekimliği Fakültesi

Istanbul, MALTEPE, 34854, Turkey (Türkiye)

Location

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 CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2026
• First Posted: July 14, 2026
• Study Start: July 16, 2026
• Primary Completion (Estimated): August 25, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: July 14, 2026

Record last verified: 2026-07

Locations

TU (1)