Local Anesthesia Pen vs Conventional Syringe in The Treatment of Pain and Dental Anxiety: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 22
- Locations
- 1
Study Overview
Brief Summary
The goal of this is to compare pain and anxiety that may occur during dental anesthesia delivery using conventional dental syringe and the dental anesthesia injector (wireless pain less pen in pediatric dentistry. This is a cross-over randomized clinical trial is to investigate if one technique more efficiant in reducing pain and anaxity. This study could include medically healthy children between the age 6-12 years old requiring restorative dental work. The main question aims to answer [is/are]: Is new painless injector pen better or equal to convintional syrange in reducing both pain and anaxity? Randomization will be generated. Children will recive the first dental treatment under eaither systems then a washout period of 14 days will be carries out, then the same patient will recive the dental treatment on the other side using the 2nd device acording to the manufactuurer instructions.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Supportive Care
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 6 Years to 12 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Children aged between 6-12 years old
- •Medically fit
- •Requiring dental restorative procedures (Filling).
Exclusion Criteria
- •Children younger than 6 years
- •Children older than 12 years
- •Any significant medical history
- •Requiring extensive restorative dental work type such as full crown coverage
Investigators
Shahad Abudawood
Assisstant Professor
King Abdulaziz University