Ege University, Faculty of Dentistry, Department of Pediatric Dentistry
Izmir, İzmir, 35100, Turkey (Türkiye)
NCT Number: NCT07759739
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 study is active but is not currently recruiting participants.
Notify Me6 year–12 year
All sexes
Interventional
Not applicable
Izmir, İzmir, 35100, Turkey (Türkiye)
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: During cavity preparation
The number of children requiring local anesthesia during cavity preparation was recorded for each study group.
Time frame: During the restorative procedure
The time required to complete cavity preparation was recorded in seconds.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Ege University
Other
Comparison of the Clinical Effects of Er:YAG Laser-Assisted and Conventional Cavity Preparation on Pain, Dental Anxiety, Sensory Responses, and Patient Comfort in Children With Molar-Incisor Hypomineralization
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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