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