Molar-Incisor Hypomineralization Vs Periodontal Health (NCT06764043) | Clinical Trial Compass
CompletedNot Applicable
Molar-Incisor Hypomineralization Vs Periodontal Health
Turkey (Türkiye)80 participantsStarted 2023-01-01
Plain-language summary
Background: To investigate the effect of molar incisor hypomineralization (MIH) on periodontal health, to evaluate the relationship between gingival crevicular fluid (GCF) volume, and GCF biomarkers such as matrix metalloproteinase-8 (MMP-8), matrix metalloproteinase-20 (MMP-20), and transforming growth factor-beta 1 (TGF-β1), and MIH.
Methods: The study was conducted on 40 pediatric patients diagnosed with MIH (Study Group/SG), and 40 pediatric patients healthy for MIH (Control Group/CG). Clinical periodontal measurements (plaque index (PI), gingival index (GI), probing pocket depth (PPD), and GCF volume were performed. Concentrations of MMP-8, MMP-20, and TGF-β1 in GCF were determined using enzyme-linked immunosorbent assay (ELISA). Mann-Whitney U test and T-test were used for comparisons between groups. Significance was set at p=0.05 for statistical analysis.
Who can participate
Age range
8 Years – 14 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:
* the ages of 8 and 14 who were diagnosed with MIH in their maxillary permanent first molars,
* had healthy maxillary permanent first molars,
* scored 3 (positive) or 4 (definitely positive) on the Frankl Behavior Scale,
* had no mental or physical disability,
* did not need urgent treatment and/or were not in pain,
* agreed to participate in the study with their parents and signed the consent form.
Exclusion Criteria:
* Children with systemic, chronic, and/ or metabolic diseases,
* under active orthodontic treatment, with developmental defects of enamel (excluding MIH), or born prematurely
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
Periodontal indexes measurement
Timeframe: 1 day
2
GCF measurement
Timeframe: 1 day
3
Evaluation of MMP-8, MMP-20 and TGF-β1 Levels by ELISA Method
Timeframe: for three days from the beginning of the study
Trial details
NCT IDNCT06764043
SponsorRecep Tayyip Erdogan University Training and Research Hospital