Assessment of Pain and Anxiety During Infiltration Anesthesia Using Dental Anesthesia Injector Versus Conventional Syringe in Pediatric Patients

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-8
SponsorAin Shams University

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 volunteers

Qualifiers

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

Design model

Crossover

Treatments tested in this trial

  • Dental Anesthesia Injector

    Device

    Topical 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 intervention

    Topical 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

40 Participants
are divided into 2 treatment groups
Group A: Dental Anesthesia InjectorExperimental treatment 1 intervention
Group B: Conventional syringeActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
The pain felt by patient will be assessed by Visual analogue scale, Pulse rate and Oxygen saturation at day 1 of anesthesia injection.
2

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.

Time frame
the scale will be used at day 1 of anesthesia injection

Secondary outcomes

1

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.

Time frame
The assessment will be done during dental visit at day 1 of anesthesia injection

Other outcomes

Sponsors and contacts

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