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Clinical Trials in Turkey / NCT07759739
Active, not recruiting Not applicable

Er:YAG Laser Versus Conventional Cavity Preparation in Children With Molar-Incisor Hypomineralization

NCT07759739 · tracked via the Priya Life Science Turkey tracker
Sponsor
Ege University
Phase
Not applicable
Started
2026-01-03
Last updated
2026-08-12

Condition(s) studied

Molar-Incisor Hypomineralization (MIH)

Investigational drug(s) / intervention(s)

Er:YAG Laser-Assisted Cavity PreparationConventional Rotary Cavity Preparation

Er:YAG Laser-Assisted Cavity Preparation: Cavity preparation was performed using an Er:YAG laser (2940 nm). Enamel and dentin were selectively removed using laser parameters appropriate for each dental tissue. The prepared cavity was subsequently restored using an adhesive system and resin composi

Conventional Rotary Cavity Preparation: Cavity preparation was performed using conventional high-speed rotary instruments and diamond burs. The prepared cavity was subsequently restored using the same adhesive system and resin composite used in the laser group.

Study 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.

Eligibility

Sex
ALL
Min age
6 Years
Max age
12 Years
Healthy volunteers
No
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 participate.

Primary outcome measure(s)

  • Pain-Related Behavior Assessed Using the FLACC Scale — During cavity preparation
    Pain-related behavior during cavity preparation was assessed using the Face, Legs, Activity, Cry, and Consolability (FLACC) scale. The total score ranges from 0 to 10, with higher scores indicating greater pain-related behavioral responses.
  • Self-Reported Pain Assessed Using the Wong-Baker FACES Pain Rating Scale — Immediately after cavity preparation
    Pain experienced during cavity preparation was self-reported using the Wong-Baker FACES Pain Rating Scale. Scores range from 0 to 10, with higher scores indicating greater pain.

Trial sites (1)

FacilityCityRegionStatus
Ege University, Faculty of Dentistry, Department of Pediatric Dentistry Izmir İzmir

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Other trials for the same condition

Clinical Performance of Glass Hybrid and Alkasite Restorative Systems in MIH-Affected Permanent First Molars Starting soon
Assessment of Peridontal Inflamatuar Markers in MIH Starting soon
Comparison of Computer-Assisted and Conventional Local Anesthesia in Children With Molar-Incisor Hypomineralization Starting soon
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07759739 on ClinicalTrials.gov ↗ ← All trials in Turkey