Assessment of Peridontal Inflamatuar Markers in MIH (NCT07701642) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Assessment of Peridontal Inflamatuar Markers in MIH
Turkey (Türkiye)76 participantsStarted 2026-07-16
Plain-language 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.
Who can participate
Age range
8 Years – 13 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Concentration of proinflammatory and anti-inflammatory cytokines in gingival crevicular fluid
Timeframe: Baseline, 1 month after initial periodontal therapy, and 3 months after initial periodontal therapy
2
Concentration of matrix metalloproteinases in gingival crevicular fluid
Timeframe: Baseline, 1 month after initial periodontal therapy, and 3 months after initial periodontal therapy
3
Total oxidant status and total antioxidant status in gingival crevicular fluid
Timeframe: Baseline, 1 month after initial periodontal therapy, and 3 months after initial periodontal therapy