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

NCT07759739 | Active Not Recruiting

• 1 other identifier: 25-8/8
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Molar-Incisor Hypomineralization (MIH)

Keywords

Molar-Incisor Hypomineralization; MIH; Er:YAG Laser; Cavity Preparation; Pediatric Dentistry; Dental Anxiety; Dental Pain; Sensory Experience; Restorative Dental Treatment

Outcome Measures

Primary Outcomes (2)

• Pain-Related Behavior Assessed Using the FLACC Scale

  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.

  During cavity preparation

• Self-Reported Pain Assessed Using the Wong-Baker FACES Pain Rating Scale

  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.

  Immediately after cavity preparation

Secondary Outcomes (9)

• Dental Anxiety Assessed Using the Modified Child Dental Anxiety Scale-Faces Version

  Immediately before and immediately after the restorative procedure

• Change in Heart Rate

  From immediately before to immediately after the restorative procedure

• Change in Peripheral Oxygen Saturation

  From immediately before to immediately after the restorative procedure

• Sensory experience and patient comfort

  Immediately after the restorative procedure

• Requirement for Local Anesthesia

  During cavity preparation

Study Arms (2)

Er:YAG Laser-Assisted Cavity Preparation

EXPERIMENTAL

Cavity preparation was performed using an Er:YAG laser, followed by restoration with an adhesive system and resin composite.

Device: Er:YAG Laser-Assisted Cavity Preparation

Conventional Rotary Cavity Preparation

ACTIVE COMPARATOR

Cavity preparation was performed using conventional rotary instruments, followed by restoration with the same adhesive system and resin composite.

Procedure: Conventional Rotary Cavity Preparation

Interventions

Er:YAG Laser-Assisted Cavity Preparation DEVICE

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

Er:YAG Laser-Assisted Cavity Preparation

Conventional Rotary Cavity Preparation PROCEDURE

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.

Conventional Rotary Cavity Preparation

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ege University: lead

Study Sites (1)

Ege University, Faculty of Dentistry, Department of Pediatric Dentistry

Izmir, İzmir, 35100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Molar Hypomineralization; Toothache

Condition Hierarchy (Ancestors)

Dental Enamel Hypomineralization; Developmental Defects of Enamel; Tooth Abnormalities; Stomatognathic System Abnormalities; Stomatognathic Diseases; Tooth Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Facial Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Masking was not feasible because the laser-assisted and conventional preparation methods produced distinguishable visual, auditory, and sensory experiences for the participants and clinical investigators.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant, Principal Investigator

Model Details: Participants were randomly allocated in a 1:1 ratio to either Er:YAG laser-assisted cavity preparation or conventional rotary cavity preparation.

Study Record Dates

• First Submitted: July 21, 2026
• First Posted: August 12, 2026
• Study Start: January 3, 2026
• Primary Completion (Estimated): September 10, 2026
• Study Completion (Estimated): September 10, 2026
• Last Updated: August 12, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)