Investigation of Periodontal Inflammatory Mediators in Permanent Molars Affected by Molar-incisor Hypomineralization
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Marmara University
- Enrollment
- 76
- Locations
- 1
- Primary Endpoint
- Concentration of proinflammatory and anti-inflammatory cytokines in gingival crevicular fluid
Study Overview
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.
Detailed Description
Participants will:
Provide written informed consent from their parent or legal guardian before enrollment.
Complete a dental and oral hygiene history questionnaire. Undergo a comprehensive oral examination, including assessment of MIH severity using the MIH Treatment Need Index (MIH-TNI), dentin hypersensitivity using the Schiff Cold Air Sensitivity Scale, plaque index, gingival index, bleeding on probing, and periodontal probing depth.
Provide gingival crevicular fluid samples collected using Periopaper® strips for analysis of periodontal inflammatory mediators.
The following clinical indices and assessment criteria will be used during the clinical examination.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 8 Years to 13 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
MIH patients requiring initial periodontal treatment
Intervention: Initial periodontal treatment (Procedure)
Patients without MIH requiring initial periodontal treatment
Intervention: Initial periodontal treatment (Procedure)
Outcomes
Primary Outcomes
Concentration of proinflammatory and anti-inflammatory cytokines in gingival crevicular fluid
Time Frame: Baseline, 1 month after initial periodontal therapy, and 3 months after initial periodontal therapy
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).
Concentration of matrix metalloproteinases in gingival crevicular fluid
Time Frame: Baseline, 1 month after initial periodontal therapy, and 3 months after initial periodontal therapy
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.
Total oxidant status and total antioxidant status in gingival crevicular fluid
Time Frame: Baseline, 1 month after initial periodontal therapy, and 3 months after initial periodontal therapy
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.
Secondary Outcomes
No secondary outcomes reported