NCT Number: NCT07736677
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, and change in dental anxiety.
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Notify Me6 year–12 year
All sexes
Interventional
Not applicable
Istanbul Beykent University, Istanbul, Turkey (Türkiye)
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, and dental anxiety was assessed before and after local anaesthetic administration using the Modified Child Dental Anxiety Scale.
Healthy volunteers accepted: No
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Inclusion criteria
Exclusion criteria
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 1:200,000 epinephrine, 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 1:200,000 epinephrine 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 1:200,000 epinephrine was deposited slowly. Adequate anaesthesia was confirmed by patient-reported lip numbness before restorative treatment was started.
Time frame: During the restorative procedure after local anesthesia administration, within the single treatment visit
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: At the time of needle insertion into the oral mucosa, immediately before delivery of the local anaesthetic solution, during the single treatment visit
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: During delivery of the local anaesthetic solution, immediately after needle penetration, during the single treatment visit
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 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
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: Immediately before and immediately after local anaesthetic administration, during the single treatment visit
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), producing a total score ranging from 8 to 40. Higher total scores indicate greater dental anxiety. Change was calculated as the post-anaesthesia score minus the pre-anaesthesia score; negative values indicate a reduction in dental anxiety.
Ege University
Other
Digital Intraosseous Anesthesia in MIH-Affected Permanent Molars: A Randomized Clinical Trial
Acronym: DIA-MIH
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