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SleeperOne® 5 Intraosseous Anesthesia in MIH

NCT07741487 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2026-08-06

No results posted yet for this study

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

Interventions

DEVICE

SleeperOne® 5 Computer-Controlled Intraosseous Anesthesia

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

PROCEDURE

Conventional Local Anesthesia

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

Sponsors & Collaborators

  • Ankara University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
8 Years
Max Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-01
Primary Completion
2025-03-01
Completion
2025-12-01

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 NCT07741487 on ClinicalTrials.gov