The main questions this study aims to answer are:
Does computer-controlled local anesthesia cause less pain and anxiety than conventional local anesthesia in children with molar-incisor hypomineralization (MIH)?
Is there a difference between the two methods in anesthesia onset time, injection duration, physiological responses, and the need for additional anesthesia?
Researchers will compare computer-controlled and conventional local anesthesia in children aged 8-12 years with MIH. Each child will receive both anesthesia methods during separate dental visits, on comparable permanent molar teeth, to determine which method is more comfortable, effective, and preferred by children.
Children aged 8-12 years
Children with no systemic disease
Children with no pathology involving the oral region, such as trauma, cysts, or tumors
Children who have not used antibiotics within the past month
Children in whom local anesthesia cannot be administered due to lack of cooperation
Children who require pulp treatment after enrollment in the study will be withdrawn from the study.
Parallel
Computer-Controlled Local Anesthesia
DeviceLocal anesthesia will be administered using the SleeperOne computer-controlled local anesthetic delivery system according to the manufacturer's pediatric protocol. The device electronically controls the flow rate and pressure of the anesthetic solution. A 4% articaine solution with 1:100,000 epinephrine will be administered before restorative treatment of the MIH-affected permanent molar.
Conventional Local Anesthesia
Procedure/SurgeryLocal anesthesia will be administered using a conventional dental syringe. Buccal infiltration will be used for maxillary teeth, and an inferior alveolar nerve block will be used for mandibular teeth. A 4% articaine solution with 1:100,000 epinephrine will be administered before restorative treatment of the MIH-affected permanent molar.
Injection pain assessed using the Wong-Baker Faces Pain Rating Scale
Pain intensity will be assessed during local anesthetic injection using the Wong-Baker Faces Pain Rating Scale (score range: 0-10; higher scores indicate greater pain).
Injection pain assessed using the Visual Analog Scale (VAS)
Pain intensity will be assessed immediately after local anesthetic injection using a 100-mm Visual Analog Scale (0=no pain, 100=worst imaginable pain; higher scores indicate greater pain).
Behavioral pain assessed using the Face, Legs, Activity, Cry, Consolability (FLACC) Scale
Behavioral pain will be assessed during local anesthetic injection using the Face, Legs, Activity, Cry, Consolability (FLACC) Scale (score range: 0-10; higher scores indicate greater pain).
Successful local anesthesia during restorative treatment
Successful local anesthesia will be defined as completion of cavity preparation and restorative treatment without the need for supplemental local anesthesia and without interruption of treatment because of pain. The outcome will be reported as the percentage of treatment visits with successful local anesthesia.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
