SleeperOne® 5 Intraosseous Anesthesia in MIH

Completed · Not applicable

Conditions studied: Molar Incisor Hypomineralisation

In brief

This randomized split-mouth clinical trial evaluates whether computer-controlled intraosseous anesthesia delivered with the SleeperOne® 5 system reduces pain perception and dental anxiety compared with conventional local anesthesia during restorative treatment of children with molar-incisor hypomineralization (MIH). Thirty-five children received both anesthesia techniques in separate treatment sessions. Pain perception, behavioral responses, dental anxiety, pulse rate, and oxygen saturation were assessed at predefined time points.

Key facts

Study ID

NCT07741487

Run by

Ankara University

People needed

35

Starts

2024-01-01

Expected to finish

2025-12-01

Last updated by the study team

2026-08-06

Who can join

Age: 8 and older, up to 14. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Children aged 8 to 14 years.
• Bilateral symmetrical MIH-affected permanent first molars requiring restorative treatment.
• MIH diagnosed according to EAPD criteria.
• Positive or definitely positive Frankl Behavior Rating Scale.
• Parent or guardian provided written informed consent.

You may not qualify if…

• Acute pulpal or periapical pathology.
• Developmental dental anomalies other than MIH.
• Allergy to local anesthetic agents.
• Medical contraindication to local anesthesia.
• Analgesic or anti-inflammatory drug use within 24 hours before treatment.
• Cognitive or communication disorders affecting study assessments.
• Uncooperative behavior.

Where it is running

• Ankara University Faculty of Dentistry — Ankara, Turkey (Türkiye)

Full record on ClinicalTrials.gov

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