Status:
COMPLETED
Pain Assessment During Mandibular Nerve Block Injection With the Aid of Dental Vibe Tool in Pediatric Dental Patients
Lead Sponsor:
Nourhan M.Aly
Collaborating Sponsors:
Alexandria University
Conditions:
Anesthesia, Local
Eligibility:
All Genders
5-7 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to valuate the effectiveness of DentalVibe(DV) tool in pain reduction during local anesthetic injection compared to traditional injection without aid of DentalVibe in pedi...
Detailed Description
This study is a crossover randomized controlled clinical trial where (N=60 ) children will be selected from the outpatient clinic of Pediatric Dentistry and Public Health Department, Faculty of Dentis...
Eligibility Criteria
Inclusion
- Age range from 5-7 years.
- Patients who are in need of pulpotomy dental treatment requiring bilateral local anesthesia in the mandible.
- Children free of any systemic disease or special health care needs.
- Positive or definitely positive behavior during preoperative assessments according to the Frankl Scale.
Exclusion
- Having active sites of pathosis in the area of injection that could affect anesthetic assessment.
- Signs of irreversible pulpitis or pulp necrosis.
- Radiographs show periapical or bifurcation radiolucency.
- Patients allergic to local anesthesia or having a family history of allergy to local anesthesia.
- Patients with acute oral or facial infection (swelling and/or cellulitis).
- Patients refusing to participate.
Key Trial Info
Start Date :
December 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 15 2019
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03790540
Start Date
December 1 2018
End Date
May 15 2019
Last Update
April 10 2020
Active Locations (1)
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1
Faculty of Dentistry, Alexandria University
Alexandria, Egypt, 21512