This study aims to compare the pain felt by children during tooth extraction using two different techniques for giving local anesthesia. One group of children will receive anesthesia using a modern electronic device called SleeperOne® 5, which controls the flow and pressure of the anesthesia to reduce pain. The other group will receive anesthesia using the traditional syringe method, which is more commonly used in dental clinics.
The study will include children between the ages of 3 and 5 years old who need to have an upper baby molar tooth extracted. All children in the study will be healthy (classified as ASA I or II), and their parents must agree to participate.
During the procedure, each child will first receive a topical anesthetic gel to numb the surface. Then, based on random selection, the child will receive local anesthesia using either the SleeperOne® 5 device or the traditional syringe. Pain levels during the injection and during the extraction will be measured using special scales suitable for children. Other factors like how long the anesthesia takes to work and how long it lasts will also be recorded.
This research will help dentists understand whether the SleeperOne® 5 device offers a more comfortable experience for young children compared to the traditional method. The goal is to reduce fear and pain during dental treatments for kids.
Children aged 3-5 years old
Medically fit children classified as ASA physical status I and II
Parents acceptance to participate in the study (informed consent)
Pediatric patients having teeth that have been diagnostically confirmed as requiring extraction.
Uncooperative children.
Patients with an allergy to local anesthesia.
Children in need of treatment under general anesthesia.
Parallel
SleeperOne 5
DeviceA computerized local anesthetic delivery system (manufactured by Dental Hi-Tec, France) designed to minimize pain perception in children during dental procedures by controlling the pressure and flow rate of anesthetic injection. It will be used to deliver 3% mepivacaine (Mepecaine-L®, Alexandria Co. for Pharmaceuticals, Egypt) during maxillary primary molar extraction in pediatric patients.
(Conventional Infiltration Anesthesia)
Procedure/SurgeryLocal anesthetic solution (3% mepivacaine with no vasoconstrictor), manufactured by Alexandria Co. for Pharmaceuticals, Egypt. It will be administered using a 30-gauge short dental needle and standard dental syringe for conventional infiltration anesthesia during primary maxillary molar extraction in pediatric patients.
Pain perception during local anesthetic injection
Pain will be assessed during the injection phase using the Wong-Baker Faces Pain Rating Scale (WBFPRS), a validated tool for pediatric pain assessment. Children will be asked to point to the face that best describes their pain level immediately after the injection is completed.
Effectiveness: Onset and recovery time of local anesthesia
Effectiveness will be evaluated by recording the time from injection to onset of anesthesia and from completion of the procedure to recovery. Timing will be measured in minutes using a stopwatch.
Duration of the procedure (injecting the anesthesia)
The total length of the procedure will be recorded from the start of the anesthetic injection to the completion of tooth extraction. Time will be measured in minutes using a stopwatch.
Incidence of postoperative ulcers
The presence or absence of ulcers following the procedure will be evaluated through clinical examination and parental reporting. The outcome will be recorded as a binary value (yes/no).
Pain experienced during extraction
Pain perception during extraction will be assessed using the Sound, Eye, Motor (SEM) behavior scale. A numerical value will be recorded based on the patient's observed response.
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Aya Hesham ElSayed Mohamed ElTanahy
Lead sponsor
Cairo University
Sponsor institution
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