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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-8
SponsorTarek MHD kher al saka amini

About this trial

This clinical trial aims to compare pain perception in children during dental procedures when using a computer-controlled local anesthesia device versus a traditional syringe. Children aged 6 to 8 years who need maxillary primary molar extraction will be randomly assigned to one of four groups: three groups using different speeds of the GENI computer-controlled device, and one group using a conventional syringe. The study will assess pain using facial expression scales and physiological measures such as heart rate. The goal is to find a more comfortable method for delivering anesthesia to pediatric dental patients.

Eligibility criteria

Qualifiers

Children aged from 6 to 8 years old

Both sexes

Healthy children classified as ASA I

Children with maxillary primary molars indicated for extraction

Disqualifiers

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

Trial design

Treatments tested in this trial

  • A conventional dental syringe
  • GENI High-Speed Injection
  • GENI Moderate-Speed Injection
  • GENI Low-Speed Injection

Treatment groups

76 Participants
are divided into 4 treatment groups

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

Cairo University Status unavailable 3755220, Cairo, Giza GovernorateEgyptEgypt

Sponsors and collaborators

Tarek MHD kher al saka amini

Lead sponsor

Cairo University

Sponsor institution