Clinical Comparison of CAD/CAM Nanohybrid Composite and Hybrid Ceramic Overlays in Children With … (NCT06987448) | Clinical Trial Compass
CompletedNot Applicable
Clinical Comparison of CAD/CAM Nanohybrid Composite and Hybrid Ceramic Overlays in Children With Molar-Incisor Hypomineralisation
Turkey (Türkiye)20 participantsStarted 2023-09-11
Plain-language 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 quality of the enamel in permanent molars and can cause sensitivity, pain, and rapid tooth breakdown. In this study, children between the ages of 8 and 13 who had MIH in at least two molars received two types of onlay restorations: one made from a hybrid composite block and the other from a hybrid ceramic block. Both restorations were designed and manufactured using a digital system called CAD/CAM, which allows for more precise and efficient dental treatment.
Each child received both types of restorations-one on each side of the mouth-in a split-mouth design. The goal was to see how well each material worked over a period of six months. The restorations were evaluated by trained dentists using clinical criteria, and the children were also assessed for tooth sensitivity using a cold air test.
The main purpose of this study was to find out which material provides better clinical performance and reduces tooth sensitivity more effectively.
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:
* 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 Criteria:
* 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
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
Clinical performance of onlay restorations based on modified USPHS criteria