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NOT YET RECRUITING
NCT07733011
NA

Comparison of Computer-Assisted and Conventional Local Anesthesia in Children With Molar-Incisor Hypomineralization

Sponsor: Marmara University

View on ClinicalTrials.gov

Summary

The main questions this study aims to answer are: Does computer-controlled local anesthesia cause less pain and anxiety than conventional local anesthesia in children with molar-incisor hypomineralization (MIH)? Is there a difference between the two methods in anesthesia onset time, injection duration, physiological responses, and the need for additional anesthesia? Researchers will compare computer-controlled and conventional local anesthesia in children aged 8-12 years with MIH. Each child will receive both anesthesia methods during separate dental visits, on comparable permanent molar teeth, to determine which method is more comfortable, effective, and preferred by children.

Official title: Comparison of Computer-Assisted and Conventional Local Anesthesia in Children With Molar-Incisor Hypomineralization: A Split-Mouth Randomized Controlled Clinical Trial

Key Details

Gender

All

Age Range

8 Years - 12 Years

Study Type

INTERVENTIONAL

Enrollment

54

Start Date

2026-08-11

Completion Date

2027-11-01

Last Updated

2026-07-29

Healthy Volunteers

Yes

Interventions

DEVICE

Computer-Controlled Local Anesthesia

Local anesthesia will be administered using the SleeperOne computer-controlled local anesthetic delivery system according to the manufacturer's pediatric protocol. The device electronically controls the flow rate and pressure of the anesthetic solution. A 4% articaine solution with 1:100,000 epinephrine will be administered before restorative treatment of the MIH-affected permanent molar.

PROCEDURE

Conventional Local Anesthesia

Local anesthesia will be administered using a conventional dental syringe. Buccal infiltration will be used for maxillary teeth, and an inferior alveolar nerve block will be used for mandibular teeth. A 4% articaine solution with 1:100,000 epinephrine will be administered before restorative treatment of the MIH-affected permanent molar.

Locations (1)

Marmara Üniversitesi Recep Tayyip Erdoğan Külliyesi Sağlık Yerleşkesi, Diş Hekimliği Fakültesi

Istanbul, Maltepe, Turkey (Türkiye)