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Digital Intraosseous Anesthesia in MIH-Affected Permanent Molars

NCT07736677 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2026-07-30

No results posted yet for this study

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

Interventions

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 1:200,000 epinephrine, followed by intraosseous administration of an additional 1 mL of the same anaesthetic solution at the device-controlled slow flow rate.

PROCEDURE

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.

PROCEDURE

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.

Sponsors & Collaborators

  • Ege University

    lead OTHER

Principal Investigators

  • Alp Abidin Atesci, PhD · Istanbul Beykent University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-20
Primary Completion
2026-04-15
Completion
2026-04-15

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07736677 on ClinicalTrials.gov