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Search / Trial NCT07056101

"Study of Pain Perception Using Computer-Controlled Versus Conventional Local Anaesthesia in Children Undergoing Molar Extraction

Launched by TAREK MHD KHER AL SAKA AMINI · Jul 8, 2025

Trial Information

Current as of July 26, 2025

Not yet recruiting

Keywords

Geni Device Pain Perception Local Anesthesia Technique Articaine Computer Controlled Local Anesthesia Dental Injections

ClinConnect Summary

This clinical trial is studying how children aged 6 to 8 feel pain when they receive local anesthesia (numbing medicine) for the removal of upper baby molar teeth. The researchers are comparing a special computer-controlled device called GENI, which gives the anesthesia at different speeds, to the regular way of giving injections with a syringe. They want to see if using the GENI device can make the injection less painful and more comfortable for kids during dental procedures. Pain levels will be measured by asking the children how they feel, observing their behavior, and checking their heart rate and oxygen levels.

Children who are healthy, have upper baby molars that need to be taken out, have never had dental treatment before, and can communicate and follow simple instructions may be eligible to join. Kids with allergies to anesthesia, recent use of certain medicines, or those who are uncooperative will not be included. If selected, participants will be randomly placed into one of four groups and will have their pain carefully monitored during the injection. This study hopes to find better ways to make dental visits less scary and uncomfortable for young children.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Children aged from 6 to 8 years old
  • Both sexes
  • Healthy children classified as ASA I
  • Children with maxillary primary molars indicated for extraction
  • No previous dental experience
  • Mentally capable of communication and following instructions
  • No acute dental pain
  • Exclusion Criteria:
  • Uncooperative children or those with a behavioral management problem (Frankl rating 1 or 2)
  • Children with known allergies to the local anesthetic or dental materials used in the study
  • Children taking medications (e.g., antibiotics, analgesics) in the previous 48 hours that may alter pain perception
  • Children whose parents or legal guardians refuse to sign the informed consent form
  • Children experiencing acute dental pain

About Tarek Mhd Kher Al Saka Amini

Tarek Mhd Kher Al Saka Amini is a clinical trial sponsor dedicated to advancing medical research through the support and oversight of innovative clinical studies. Committed to upholding the highest standards of scientific integrity and patient safety, the sponsor actively collaborates with research institutions and healthcare professionals to facilitate the development of new therapies and improve clinical outcomes. Their focus encompasses a range of therapeutic areas, emphasizing evidence-based approaches to contribute meaningfully to the progression of healthcare.

Locations

Cairo, Giza, Egypt

Patients applied

0 patients applied

Trial Officials

Dr. Mariam mohsen Associate Professor of Pediatric Dentistry and Dental Public

Study Chair

Cairo University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported