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Digital Intraosseous Anesthesia in MIH-Affected Permanent Molars
Sponsor: Ege University
Summary
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.
Official title: Digital Intraosseous Anesthesia in MIH-Affected Permanent Molars: A Randomized Clinical Trial
Key Details
Gender
All
Age Range
6 Years - 12 Years
Study Type
INTERVENTIONAL
Enrollment
110
Start Date
2024-12-20
Completion Date
2026-04-15
Last Updated
2026-07-30
Healthy Volunteers
No
Conditions
Interventions
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 1:200,000 epinephrine, followed by intraosseous administration of an additional 1 mL of the same anaesthetic solution at the device-controlled slow flow rate.
Conventional Maxillary Infiltration Anaesthesia
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.
Conventional Inferior Alveolar Nerve Block Anaesthesia
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.
Locations (2)
Istanbul Beykent University
Istanbul, Turkey (Türkiye)
Ege University
Izmir, Turkey (Türkiye)