SleeperOne® 5 Intraosseous Anesthesia in MIH

NCT07741487 | Completed

• 2 other identifiers: 36290600/57/2023TDK-2024-3458
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Molar Incisor Hypomineralisation

Keywords

Molar-Incisor Hypomineralization; computer-controlled local anesthetic delivery; intraosseous anesthesia; pediatric dentistry.; SleeperOne® 5

Outcome Measures

Primary Outcomes (1)

• Pain Perception During Anesthetic Administration

  Pain intensity during local anesthetic administration assessed using the Visual Analog Scale (VAS), a 10-cm scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable. Higher scores indicate greater pain intensity.

  Immediately after completion of local anesthesia administration (T1)

Secondary Outcomes (3)

• Behavioral Pain Response

  Immediately after completion of local anesthesia administration and immediately after completion of the restorative treatment procedure.

• Dental Anxiety

  Immediately before local anesthesia administration, immediately after completion of local anesthesia administration, and immediately after completion of the restorative treatment procedure.

• Pulse Rate and Peripheral Oxygen Saturation (SpO₂)

  Before local anesthesia administration (T0), immediately after local anesthesia administration (T1), and immediately after restorative treatment (T2).

Study Arms (2)

SleeperOne® 5-Assisted Intraosseous Anesthesia

EXPERIMENTAL

Computer-controlled intraosseous anesthesia delivered using the SleeperOne® 5 system during restorative treatment of MIH-affected permanent first molars.

Device: SleeperOne® 5 Computer-Controlled Intraosseous Anesthesia

Conventional Local Anesthesia

ACTIVE COMPARATOR

Conventional local anesthesia administered using a standard dental syringe during restorative treatment of MIH-affected permanent first molars.

Procedure: Conventional Local Anesthesia

Interventions

SleeperOne® 5 Computer-Controlled Intraosseous Anesthesia DEVICE

Computer-controlled intraosseous local anesthesia delivered using the SleeperOne® 5 system during restorative treatment of MIH-affected permanent first molars.

SleeperOne® 5-Assisted Intraosseous Anesthesia

Conventional Local Anesthesia PROCEDURE

Conventional local anesthesia administered using a standard dental syringe during restorative treatment of MIH-affected permanent first molars.

Conventional Local Anesthesia

Eligibility Criteria

• Age: 8 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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.

Sponsors & Collaborators

• Ankara University: lead

Study Sites (1)

Ankara University Faculty of Dentistry

Ankara, 06560, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Molar Hypomineralization

Condition Hierarchy (Ancestors)

Dental Enamel Hypomineralization; Developmental Defects of Enamel; Tooth Abnormalities; Stomatognathic System Abnormalities; Stomatognathic Diseases; Tooth Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Due to the obvious differences between the computer-controlled intraosseous anesthesia device (SleeperOne® 5) and the conventional dental syringe, masking of the investigator and participants was not feasible. The same investigator performed both the interventions and the outcome assessments throughout the study.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: A randomized split-mouth design was used in which each participant received both interventions during two separate treatment sessions. One MIH-affected permanent first molar was treated with conventional local anesthesia and the contralateral molar with computer-controlled intraosseous anesthesia delivered using the SleeperOne® 5 system. The order of interventions was determined by computer-generated randomization, allowing each participant to serve as his or her own control.

Study Record Dates

• First Submitted: July 23, 2026
• First Posted: August 3, 2026
• Study Start: January 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: December 1, 2025
• Last Updated: August 3, 2026

Record last verified: 2026-07

Locations

TU (1)