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

N/AActive Not RecruitingNCT07759739

Ege University52 enrolled

Overview

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.

This prospective, parallel-group, randomized clinical trial was conducted to compare the clinical effects of Er:YAG laser-assisted and conventional rotary cavity preparation in children with molar-incisor hypomineralization. Fifty-two children aged 6-12 years requiring restorative treatment of a mandibular first permanent molar were allocated in a 1:1 ratio to either the Er:YAG laser group or the conventional rotary instrument group. In the laser group, cavity preparation was performed using an Er:YAG laser. In the conventional group, rotary instruments were used. Local anesthesia was not routinely administered but was provided when clinically required. Following cavity preparation, the teeth were restored using the same adhesive system and resin composite material in both groups. Pain and behavioral responses were assessed using the Wong-Baker FACES Pain Rating Scale and the Face, Legs, Activity, Cry, Consolability scale. Dental anxiety was evaluated before and after treatment using the Modified Child Dental Anxiety Scale-Faces version. Heart rate and peripheral oxygen saturation were recorded as physiological indicators. Sensory experiences, overall discomfort, willingness to undergo the same procedure again, need for local anesthesia, cavity preparation time, and total procedure time were also recorded. Postoperative discomfort and the clinical performance of the restorations were evaluated at 1-, 3-, and 6-month follow-up visits.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

Interventions

Er:YAG Laser-Assisted Cavity PreparationDEVICE

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 PreparationPROCEDURE

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.

Eligibility

Sex: ALLMin age: 6 YearsMax age: 12 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: Immediately after cavity preparation

Secondary Outcomes

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

Dental anxiety was assessed using the Modified Child Dental Anxiety Scale-Faces version (MCDAS-f). The total score ranges from 8 to 40, with higher scores indicating greater dental anxiety.

Time frame: Immediately before and immediately after the restorative procedure

Change in Heart Rate

Heart rate was recorded in beats per minute using a pulse oximeter before and after the restorative procedure.

Time frame: From immediately before to immediately after the restorative procedure

Change in Peripheral Oxygen Saturation

Peripheral oxygen saturation was recorded as a percentage using a pulse oximeter before and after the restorative procedure.

Time frame: From immediately before to immediately after the restorative procedure

Sensory experience and patient comfort

Children completed a structured questionnaire assessing discomfort related to sound, odor, perceived procedure duration, overall discomfort, and willingness to undergo the same cavity preparation method again. Each item was analyzed separately according to its categorical response options.

Time frame: Immediately after the restorative procedure

Requirement for Local Anesthesia

The number of children requiring local anesthesia during cavity preparation was recorded for each study group.

Time frame: During cavity preparation

Cavity Preparation Duration

The time required to complete cavity preparation was recorded in seconds.

Time frame: During the restorative procedure

Total Restorative Procedure Duration

The total duration of the restorative procedure, including cavity preparation, adhesive application, restoration placement, finishing, and polishing, was recorded in seconds.

Time frame: During the restorative procedure

Patient-Reported Discomfort Assessed Using a Visual Analog Scale

Discomfort was assessed using a 10-cm Visual Analog Scale ranging from 0 to 10, with higher scores indicating greater discomfort.

Time frame: Immediately before treatment, immediately after treatment, and at 1-, 3-, and 6-month follow-up visits

Clinical Performance of Restorations Assessed Using FDI Criteria

The clinical performance of the restorations was evaluated according to the World Dental Federation (FDI) criteria. Restorations were rated from 1 to 5, where scores 1 to 3 indicate clinically acceptable restorations and scores 4 and 5 indicate clinically unacceptable restorations.

Time frame: At 1-, 3-, and 6-month follow-up visits