NCT07101068 Assessment of Pain and Anxiety During Infiltration Anesthesia Using Dental Anesthesia Injector Versus Conventional Syringe in Pediatric Patients
| NCT ID | NCT07101068 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ain Shams University |
| Condition | Dental Caries |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2024-01-25 |
| Primary Completion | 2025-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2024-01-25 with a primary completion date of 2025-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Inclusion Criteria: * 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 Exclusion Criteria: * Presence of gingivitis, dental abscess, facial trauma/ injury * Administration of analgesic 48 h before randomization * Presence of allergy from local anesthesia
Contact & Investigator
Sarah Mohamed Shafik, Associate Professor
STUDY DIRECTOR
Pediatric Dentistry department, Ain Shams University
Frequently Asked Questions
Who can join the NCT07101068 clinical trial?
This trial is open to participants of all sexes, aged 6 Years or older, up to 8 Years, studying Dental Caries. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07101068 currently recruiting?
Yes, NCT07101068 is actively recruiting participants. Contact the research team at samaa.abdo@dent.asu.edu.eg for enrollment information.
Where is the NCT07101068 trial being conducted?
This trial is being conducted at Cairo, Egypt, Cairo, Egypt.
Who is sponsoring the NCT07101068 clinical trial?
NCT07101068 is sponsored by Ain Shams University. The principal investigator is Sarah Mohamed Shafik, Associate Professor at Pediatric Dentistry department, Ain Shams University. The trial plans to enroll 40 participants.