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

NCT07733011 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2026-07-29

No results posted yet for this study

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.

Conditions

  • Molar-Incisor Hypomineralization
  • Molar-Incisor Hypomineralization (MIH)
  • Computer-Controlled Local Anesthesia

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.

Sponsors & Collaborators

  • Marmara University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-08-11
Primary Completion
2027-08-25
Completion
2027-11-01

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 NCT07733011 on ClinicalTrials.gov