Er:YAG Laser Versus Conventional Cavity Preparation in Children With Molar-Incisor Hypomineraliza… (NCT07759739) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Er:YAG Laser Versus Conventional Cavity Preparation in Children With Molar-Incisor Hypomineralization
Turkey (Türkiye)52 participantsStarted 2026-01-03
Plain-language summary
This randomized clinical trial compares Er:YAG laser-assisted and conventional rotary cavity preparation in children aged 6-12 years with molar-incisor hypomineralization. A total of 52 children are randomly assigned to one of the two preparation methods. The study evaluates pain, dental anxiety, sensory experiences, physiological responses, patient comfort, need for local anesthesia, and procedure duration. Postoperative discomfort and the clinical performance of restorations are also assessed during follow-up visits at 1, 3, and 6 months.
Who can participate
Age range
6 Years – 12 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 6 to 12 years.
* Diagnosis of molar-incisor hypomineralization according to the European Academy of Paediatric Dentistry diagnostic criteria.
* Presence of mild or moderate molar-incisor hypomineralization.
* Presence of an erupted mandibular first permanent molar (tooth 36 or 46) requiring restorative treatment.
* Presence of a single-surface occlusal carious lesion classified as ICDAS code 4 or 5.
* Vital target tooth without clinical or radiographic signs of pulpal or periapical pathology.
* No previous restorative treatment of the target tooth.
* Cooperative behavior corresponding to Frankl behavior rating scores 3 or 4 and Venham scores 0 to 2.
* Written informed consent provided by a parent or legal guardian.
* Child assent to participate in the study.
Exclusion Criteria:
* Presence of a systemic or neurodevelopmental condition that could affect pain perception, anxiety, communication, or cooperation.
* Use of analgesic, anxiolytic, sedative, or other medication that could influence pain or anxiety assessment before treatment.
* Presence of spontaneous dental pain, irreversible pulpitis, pulp necrosis, or periapical pathology in the target tooth.
* Requirement for multisurface cavity preparation or extensive restorative treatment.
* Previous restorative treatment of the target tooth.
* Inability of the child or parent/legal guardian to understand or complete the study assessments.
* Refusal of the child or parent/legal guardian to …
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
Pain-Related Behavior Assessed Using the FLACC Scale
Timeframe: During cavity preparation
2
Self-Reported Pain Assessed Using the Wong-Baker FACES Pain Rating Scale