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NCT07736677

Overview

NCT ID: NCT07736677
Lead Sponsor: Ege UniversityOTHER
Official Title: Digital Intraosseous Anesthesia in MIH-Affected Permanent Molars: A Randomized Clinical Trial
Brief 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.
Conditions: Molar Incisor Hypomineralization

Status and Timeline

Status: Completed
Last Update Posted: Jul 30, 2026Actual
Start Date: Dec 20, 2024Actual
Primary Completion Date: Apr 15, 2026Actual
Completion Date

Participation Criteria

Ages Eligible for Study: Child (0-17)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion Criteria:

Children aged 6-12 years.

Confirmed diagnosis of molar-incisor hypomineralisation according to the European Academy of Paediatric Dentistry diagnostic criteria.

Presence of an MIH-affected permanent first molar classified as Würzburg Category 1 or 2a and requiring either a direct resin composite restoration or a stainless steel crown.

Positive or definitely positive behaviour according to the Frankl Behaviour Rating Scale.

No known allergy to local anaesthetics.

No relevant systemic disease.

Exclusion Criteria:

Receipt of analgesic, anxiolytic, or sedative medication within 48 hours before the treatment appointment.

Previous experience with intraosseous anaesthesia.

Presence of an acute dentoalveolar infection at the planned treatment site.

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 110Actual
Primary Purpose: Supportive Care
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

Contacts and Locations

Central Contacts: No data available
Locations: Istanbul Beykent University

Similar Studies

Participant Group/Arms

Maxillary Digital Intraosseous Anaesthesia GroupExperimental

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

Conventional Maxillary Infiltration Anaesthesia GroupActive Comparator

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

Conventional Mandibular Inferior Alveolar Nerve Block GroupActive Comparator

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

Mandibular Digital Intraosseous Anesthesia GroupExperimental

Device: SleeperOne 5 Computer-Controlled Intraosseous Anaesthesia System