Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
COMPLETED
NCT07741487
NA

SleeperOne® 5 Intraosseous Anesthesia in MIH

Sponsor: Ankara University

View on ClinicalTrials.gov

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.

Official title: Comparison of SleeperOne® 5-Assisted Intraosseous and Conventional Local Anesthesia for Pain and Anxiety Control in Children With Molar-Incisor Hypomineralization: A Randomized Split-Mouth Clinical Trial

Key Details

Gender

All

Age Range

8 Years - 14 Years

Study Type

INTERVENTIONAL

Enrollment

35

Start Date

2024-01-01

Completion Date

2025-12-01

Last Updated

2026-08-03

Healthy Volunteers

No

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.

Locations (1)

Ankara University Faculty of Dentistry

Ankara, Turkey (Türkiye)