Molar-Incisor Hypomineralization (MIH)
Conditions
Keywords
Molar-Incisor Hypomineralization, MIH, Er:YAG Laser, Cavity Preparation, Pediatric Dentistry, Dental Anxiety, Dental Pain, Sensory Experience, Restorative Dental Treatment
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.
Detailed description
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.
Interventions
DEVICEEr: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
PROCEDUREConventional 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.
Sponsors
Ege University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
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.
Intervention model description
Participants were randomly allocated in a 1:1 ratio to either Er:YAG laser-assisted cavity preparation or conventional rotary cavity preparation.
Eligibility
Sex/Gender
ALL
Age
6 Years to 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dental Anxiety Assessed Using the Modified Child Dental Anxiety Scale-Faces Version | Immediately before and immediately after the restorative procedure | 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. |
| Change in Heart Rate | From immediately before to immediately after the restorative procedure | Heart rate was recorded in beats per minute using a pulse oximeter before and after the restorative procedure. |
| Change in Peripheral Oxygen Saturation | From immediately before to immediately after the restorative procedure | Peripheral oxygen saturation was recorded as a percentage using a pulse oximeter before and after the restorative procedure. |
| Sensory experience and patient comfort | Immediately after the restorative procedure | 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. |
| Requirement for Local Anesthesia | During cavity preparation | The number of children requiring local anesthesia during cavity preparation was recorded for each study group. |
| Cavity Preparation Duration | During the restorative procedure | The time required to complete cavity preparation was recorded in seconds. |
| Total Restorative Procedure Duration | During the restorative procedure | The total duration of the restorative procedure, including cavity preparation, adhesive application, restoration placement, finishing, and polishing, was recorded in seconds. |
| Patient-Reported Discomfort Assessed Using a Visual Analog Scale | Immediately before treatment, immediately after treatment, and at 1-, 3-, and 6-month follow-up visits | Discomfort was assessed using a 10-cm Visual Analog Scale ranging from 0 to 10, with higher scores indicating greater discomfort. |
| Clinical Performance of Restorations Assessed Using FDI Criteria | At 1-, 3-, and 6-month follow-up visits | 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. |
Countries
Turkey (Türkiye)
Outcome results
None listed