About this trial
This randomized controlled trial is conducted on pediatric dental patients to compare the effectiveness of local anesthesia administered using a dental anesthesia injector device versus the traditional syringe method. The study aims to assess and compare pain and anxiety levels associated with both methods, using both subjective (self-reported) and objective measures. The goal is to identify an alternative technique that minimizes pain and anxiety in pediatric dental patients.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
normal healthy patients (ASA I)
Undergoing the first dental local anesthesia experience
Presence of one at least vital deeply carious maxillary primary molar indicated for pulpotomy on each side of maxilla
Score 3 or 4 of Frankl scale of child behavior
Disqualifiers
Presence of gingivitis, dental abscess, facial trauma/ injury
Administration of analgesic 48 h before randomization
Presence of allergy from local anesthesia
Trial design
Crossover
Treatments tested in this trial
Dental Anesthesia Injector
DeviceTopical anesthesia lidocain for 1 minute will be applied on previously dried mucosa. Local anesthesia administration( artican 4% +1/100,000 With extra short needles 30G-10mm ) using Dental Anesthesia Injector.
conventional syringe
Other interventionTopical anesthesia lidocain for 1 minute will be applied on previously dried mucosa. Local anesthesia administration( artican 4% +1/100,000 With extra short needles 30G-10mm ) using conventional syringe
Treatment groups
Trial outcomes
Primary outcomes
Pain during injection
The pain felt by patient will be assessed by Visual analogue scale which is a subjective scale {rating from 0 (no pain) to 10 (worst pain ) } Pulse rate and oxygen saturation will be assessed also which are objective tools where the normal pulse rate is from 60 to 100 beats per minute, more than normal heart rate for the patient during injection and 1 minute after means anxiety The normal Oxygen saturation of the body is from 95% up to 100% the increase in the rating of the Oxygen saturation during the injection and 1 minute after injection means that the patient feels anxiety
Anxiety felt by the patient
Anxiety felt by the patient during dental visit will be assessed using Corah Dental Anxiety Scale which is a subjective scale consist of brief questionnaire designed to measure anxiety related to dental visits, each question has 5 answers from a to e (a) answers give rating 1 that mean least anxiety felt and (e) answers give rating 5 that mean sever anxiety. If the total rating of the 4 questions \<9 means that the patient has mild anxiety. If the total rating from 15 to 20 means that the patient has sever anxiety.
Secondary outcomes
Need for additional anesthesia
Need for additional anesthesia will be assessed by the operator if the patient feels pain and we have to administer additional anesthesia with the same concentration and the same tool of injection for the second time to treat the same tooth at same dental visit.
Sponsors and contacts
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