Status:
ACTIVE_NOT_RECRUITING
Comparison of Semi-direct CAD/CAM Hybrid Composite Onlays With Hybrid Ceramic Onlays in Molar - Incisor Hypomineralization in Children
Lead Sponsor:
Alp Akça
Collaborating Sponsors:
Marmara University
Conditions:
Enamel Hypoplasia
Molar-Incisor Hypomineralization (MIH)
Eligibility:
All Genders
8-13 years
Phase:
NA
Brief Summary
This clinical study was conducted to compare two different dental materials used in the treatment of children who have a condition called molar-incisor hypomineralization (MIH). MIH affects the qualit...
Detailed Description
Molar-Incisor Hypomineralization (MIH) is a developmental enamel defect that primarily affects the first permanent molars and frequently the incisors. It is characterized by hypomineralized enamel wit...
Eligibility Criteria
Inclusion
- Children aged between 8 and 13 years
- Presence of at least two permanent first molars affected by MIH
- MIH-affected molars classified as score 2b, 2c, 4b, or 4c according to the MIH-TNI index
- Symmetrical molars suitable for split-mouth comparison
- Cooperative behavior sufficient to allow treatment under local anesthesia
- Signed informed consent obtained from parent or legal guardian
Exclusion
- Presence of systemic or syndromic diseases affecting enamel development
- History of bruxism or parafunctional habits
- Presence of pulp involvement, fistula, or periapical pathology in the target teeth
- Allergies to dental materials used in the study (e.g., resin-based composites, adhesives)
- Participation in another clinical trial within the past 30 days
- Inability to attend scheduled follow-up appointments at 6, 12, and 18 months
- Use of medication affecting pain perception or healing process
Key Trial Info
Start Date :
September 11 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 11 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06987448
Start Date
September 11 2023
End Date
September 11 2025
Last Update
May 29 2025
Active Locations (1)
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1
Marmara University, School of Dentistry, Department of Pediatric Dentistry. Marmara Üniversitesi Sağlık Yerleşkesi, Diş Hekimliği Fakültesi, Başıbüyük Yolu 9/3 34854 Başıbüyük / Maltepe / İSTANBUL.
Istanbul, Istanbul, Turkey (Türkiye), 34854