SleeperOne vs. Conventional Infiltration: Pain Perception in Mandibular Primary Molar Extraction
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3-5
SponsorAmeera Alaa Eldin Abdalazim Khalifa
About this trial
This clinical trial is being conducted in the Department of Pediatric Dentistry, Faculty of Dentistry, Cairo University. The purpose of the study is to compare the pain perception and comfort of children during tooth extraction when using a computer-controlled local anesthetic device (SleeperOne® 5) versus the conventional syringe infiltration technique.
Children between 3 and 5 years of age who require extraction of a maxillary primary molar will be invited to participate. Before starting, a topical anesthetic gel (benzocaine) will be applied. Then, local anesthesia will be given using either the SleeperOne® device or the traditional syringe, depending on the group assigned.
Pain during injection and extraction will be assessed using both child-friendly rating scales and independent evaluation by the dentist. Patient anxiety, heart rate, and blood pressure will also be recorded.
This study aims to provide evidence on whether computer-controlled anesthesia can reduce children's pain and anxiety compared with the conventional method, leading to a more comfortable dental experience.
The study is a randomized clinical trial and will be conducted in a single visit at the Pediatric Dentistry Outpatient Clinic, Faculty of Dentistry, Cairo University. The results may help improve pain management and patient comfort during dental treatment for children.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Children Aged between 3 to 5 years.
Medically fit children classified as ASA physical status I and II
Parents acceptance to participate in the study (informed consent)
Children with teeth diagnostically confirmed to require extraction
Disqualifiers
Patients with an allergy to local anesthesia.
Uncooperative children
Children requiring general anesthesia
Trial design
Design model
Parallel
Treatments tested in this trial
SleeperOne®, dental Hitec, France
DeviceSleeperOne® is a computerized local anesthetic delivery system used to deliver 3% mepivacaine following application of 20% benzocaine topical gel. It is designed to reduce injection pain and improve comfort during pediatric dental procedures.
Conventional Infiltration
Procedure/SurgeryLocal anesthetic (3% mepivacaine) will be administered using a conventional dental syringe after the application of 20% benzocaine topical anesthetic.
Treatment groups
28 Participants
are divided into 2 treatment groupsGroup A: Conventional InfiltrationActive comparator 1 intervention
Group B: SleeperOne® DeviceExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Pain during injection
Pain during injection will be assessed using the Sound-Eye-Motor (SEM) pain scale, which is a validated observational scale for evaluating pain response in pediatric patients. The SEM scale consists of three components-sound, eye, and motor reaction-each scored from 1 to 4, where a lower score indicates minimal or no pain and a higher score indicates greater discomfort. The total score is interpreted to reflect the child's behavioral reaction to the injection stimulus.
Time frame
immediately during local anesthetic injectionSecondary outcomes
1
Patient anxiety
Patient anxiety will be assessed during the dental anesthesia procedure using the Modified Child Dental Anxiety Scale (MCDAS). The scale provides a subjective measure of the child's level of anxiety, scored from 8 to 40, with higher scores indicating greater anxiety.
Time frame
During injection and extraction in the same clinical visit2
Heart rate changes
Heart rate will be monitored using a digital pulse oximeter as an objective measure of patient anxiety. Baseline and intraoperative readings will be compared between groups.
Time frame
within 15 minutes after injection3
Blood pressure changes
Blood pressure will be recorded using a digital sphygmomanometer to evaluate physiological responses to local anesthesia. Baseline and intraoperative readings will be compared.
Time frame
within 15 minutes after injection4
Soft tissue injury
Soft tissue injury (lip or cheek biting, trauma due to numbness) will be reported by parents/patients during follow-up. Any incidence will be documented and compared between groups.
Time frame
Within 24 hours after the procedure.Locations
Sponsors and contacts
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Ameera Alaa Eldin Abdalazim Khalifa
Lead sponsor
Cairo University
Sponsor institution
Source ClinicalTrials.gov
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