An interventional study of SleeperOne 5 Computer-Controlled Intraosseous Anaesthesia System and Conventional Maxillary Infiltration Anaesthesia in Molar Incisor Hypomineralization, sponsored by Ege University. Completed at 2 sites in Turkey (Türkiye). Open to participants aged 6 Years to 12 Years. Per ClinicalTrials.gov, last updated 2026-09-23.
Sponsored by Ege University · Not applicable, Interventional, and Supportive care
This multicentre, randomized clinical trial compared digital intraosseous anaesthesia with conventional local anaesthetic techniques in children aged 6-12 years receiving restorative treatment for MIH-affected permanent first molars. Within the maxillary stratum, digital intraosseous anaesthesia was compared with conventional infiltration anaesthesia; within the mandibular stratum, it was compared with inferior alveolar nerve block. The primary outcome was child-reported pain during restorative treatment. Secondary outcomes included pain during needle penetration and anaesthetic solution delivery, observed pain-related behaviour, change in dental anxiety, and the requirement for supplemental local anaesthesia during restorative treatment.
Children with an MIH-affected permanent first molar requiring restorative treatment were randomized separately within the maxillary and mandibular strata. In the maxillary stratum, digital intraosseous anaesthesia was compared with conventional infiltration anaesthesia. In the mandibular stratum, digital intraosseous anaesthesia was compared with conventional inferior alveolar nerve block. Only one MIH-affected permanent first molar was included for each child.
Pain during needle penetration, anaesthetic solution delivery, and restorative treatment was assessed using the Wong-Baker FACES Pain Rating Scale. Pain-related behavioural responses were assessed using the Face, Legs, Activity, Cry, Consolability scale. Dental anxiety was assessed using the Modified Child Dental Anxiety Scale immediately before local anaesthesia administration and immediately after completion of restorative treatment. The requirement for supplemental local anaesthesia during restorative treatment was recorded for each participant.
Exclusion Criteria:
Children in this arm received computer-controlled digital intraosseous anaesthesia using the SleeperOne 5 system before restorative treatment of one MIH-affected permanent first molar in the maxillary arch.
Device: SleeperOne 5 Computer-Controlled Intraosseous Anaesthesia System
Children in this arm received conventional supraperiosteal infiltration anaesthesia in the buccal sulcus adjacent to one MIH-affected maxillary permanent first molar before restorative treatment.
Procedure: Conventional Maxillary Infiltration Anaesthesia
Children in this arm received conventional inferior alveolar nerve block anaesthesia before restorative treatment of one MIH-affected mandibular permanent first molar.
Procedure: Conventional Inferior Alveolar Nerve Block Anaesthesia
Children in this arm received computer-controlled digital intraosseous anaesthesia using the SleeperOne 5 system before restorative treatment of one MIH-affected permanent first molar in the mandibular arch.
Device: SleeperOne 5 Computer-Controlled Intraosseous Anaesthesia System
Digital intraosseous anaesthesia was administered using the SleeperOne 5 computer-controlled system (Dental Hi Tec, Cholet, France). Initial mucosal anaesthesia was achieved using 0.1-0.2 mL of 4% articaine with 1:100,000 epinephrine (Ultracain D-S forte), followed by intraosseous administration of an additional 1 mL of the same anaesthetic solution at the device-controlled slow flow rate.
Supraperiosteal infiltration anaesthesia was performed using a standard aspirating dental syringe and a 27-gauge short needle. One millilitre of 4% articaine with 1:100,000 epinephrine (Ultracain D-S forte) was deposited slowly into the buccal sulcus adjacent to the MIH-affected maxillary permanent first molar.
Inferior alveolar nerve block anaesthesia was administered using a standard aspirating dental syringe and a 27-gauge long needle. One millilitre of 4% articaine with 1:100,000 epinephrine (Ultracain D-S forte) was deposited slowly. Adequate anaesthesia was confirmed by patient-reported lip numbness before restorative treatment was started.
Child-Reported Pain During Dental Treatment Assessed Using the Wong-Baker FACES Pain Rating Scale
Children rated the pain experienced during the restorative procedure using the Wong-Baker FACES Pain Rating Scale. The scale comprises six faces scored 0, 2, 4, 6, 8, and 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity.
Time frame: During the restorative procedure after local anesthesia administration, within the single treatment visit
Child-Reported Pain During Needle Penetration Assessed Using the Wong-Baker FACES Pain Rating Scale
Children rated the pain experienced during needle penetration using the Wong-Baker FACES Pain Rating Scale. The scale comprises six faces scored 0, 2, 4, 6, 8, and 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity.
Time frame: At the time of needle insertion into the oral mucosa, immediately before delivery of the local anaesthetic solution, during the single treatment visit
Child-Reported Pain During Local Anaesthetic Solution Delivery Assessed Using the Wong-Baker FACES Pain Rating Scale
Children rated the pain experienced during delivery of the local anaesthetic solution using the Wong-Baker FACES Pain Rating Scale. The scale comprises six faces scored 0, 2, 4, 6, 8, and 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity.
Time frame: During delivery of the local anaesthetic solution, immediately after needle penetration, during the single treatment visit
Observer-Rated Pain-Related Behaviour During Local Anaesthetic Administration Assessed Using the FLACC Scale
Pain-related behaviour was independently assessed using the Face, Legs, Activity, Cry, Consolability (FLACC) scale. Each of the five components is scored from 0 to 2, producing a total score ranging from 0 to 10. A total score of 0 indicates a relaxed and comfortable child, 1-3 indicates mild discomfort, 4-6 indicates moderate pain, and 7-10 indicates severe pain. Higher scores indicate greater pain-related behavioural responses.
Time frame: During the local anaesthetic injection sequence, from needle penetration through completion of anaesthetic solution delivery, before commencement of the restorative procedure, during the single treatment visit
Change in Dental Anxiety From Before Local Anaesthesia to After Completion of Restorative Treatment Assessed Using the Modified Child Dental Anxiety Scale
Dental anxiety was assessed using the eight-item Modified Child Dental Anxiety Scale (MCDAS). Each item is scored from 1 (relaxed) to 5 (extremely anxious), yielding a total score ranging from 8 to 40. Higher scores indicate greater dental anxiety. Change was calculated as the post-treatment score minus the pre-anaesthesia score; negative values indicate a reduction in dental anxiety.
Time frame: Immediately before local anaesthetic administration and immediately after completion of restorative treatment, during the same treatment visit.
Requirement for Supplemental Local Anaesthesia During Restorative Treatment
The number and proportion of children who required an additional local anaesthetic injection because the pain control provided by the allocated technique was considered insufficient were recorded for each treatment group.
Time frame: During restorative treatment following administration of the allocated anaesthetic technique, within the same treatment visit.
Plan to share: No — Individual participant data will not be shared. Study findings will be reported only in aggregate form to protect participant privacy, as the study involves children and no external IPD-sharing plan was established in the study protocol.
This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Ege University