An interventional study of Er:YAG Laser-Assisted Cavity Preparation and Conventional Rotary Cavity Preparation in Molar-Incisor Hypomineralization (MIH), sponsored by Ege University. Active, not recruiting at 1 site in Turkey (Türkiye). Open to participants aged 6 Years to 12 Years. Per ClinicalTrials.gov, last updated 2026-08-12.
Sponsored by Ege University · Not applicable, Interventional, and Treatment
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.
133 studies on the registry are indexed under Molar Hypomineralization; 46 are open to participants now.
This study's planned enrollment of 52 is close to the median of 53 across 104 interventional studies indexed under Molar Hypomineralization.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Cavity preparation was performed using conventional rotary instruments, followed by restoration with the same adhesive system and resin composite.
Procedure: Conventional Rotary 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
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.
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
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
Plan to share: No — Individual participant data will not be shared because the study involves children, and the informed consent obtained from parents or legal guardians did not include permission for sharing individual-level data with other researchers. This decision is intended to protect participant privacy and confidentiality.
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