Assessment of Peridontal Inflamatuar Markers in MIH
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age8-13
SponsorMarmara University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial 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).
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Initial periodontal treatment
Procedure/SurgeryDOS samples will be taken before and after treatment
Treatment groups
76 Participants
are divided into 2 treatment groupsGroup A: MIH patients requiring initial periodontal treatment1 intervention
Group B: Patients without MIH requiring initial periodontal treatment1 intervention
Trial outcomes
Primary outcomes
1
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).
Time frame
Baseline, 1 month after initial periodontal therapy, and 3 months after initial periodontal therapy2
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.
Time frame
Baseline, 1 month after initial periodontal therapy, and 3 months after initial periodontal therapy3
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.
Time frame
Baseline, 1 month after initial periodontal therapy, and 3 months after initial periodontal therapySponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: