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Completed NCT07741487

SleeperOne® 5 Intraosseous Anesthesia in MIH

Conditions: Molar Incisor Hypomineralisation

Sex: All
Ages: 8 Years – 14 Years
Healthy volunteers: No
Phase: NA
Enrollment: 35
Sponsor: Ankara University

Location: Ankara University Faculty of Dentistry Ankara

Summary

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.

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07741487). StuddyBuddy aggregates publicly available trial information.