Pain Perception of Maxillary Infiltration Injection of Dental Local Anesthesia Using "DentalVibe Comfort System" Compared to Maxillary Infiltration Injection Alone in a Group of Egyptian Children: A Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Cairo University
- Enrollment
- 21
- Primary Endpoint
- pain during injection
Study Overview
Brief Summary
The aim of this study is to compare pain during maxillary infiltration local anesthesia injection with the aid of DentalVibe comfort system in comparison to maxillary infiltration injection alone in pediatric dental patients.
Detailed Description
The aim of this study is to compare pain during maxillary infiltration local anesthesia injection with the aid of DentalVibe comfort system in comparison to maxillary infiltration injection alone.
Intervention:
History taking from the child and the parent including personal, medical and dental history as in the examination sheet (Appendix A) to assess inclusion criteria.
Clinical procedure:
Intervention group:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 6 Years to 7 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Healthy children aged 6-7 years old.
- •Apparently healthy Children.
- •Cooperative children.
- •Children with carious maxillary bilateral primary molars indicated for extraction.
Exclusion Criteria
- •Children who are allergic to amide group.
- •Children with Neurologic disorders.
- •Children with mental disability.
- •Presence of periapical or gingival legion.
- •Severe Gingivitis.
Arms & Interventions
DV group
Device: injection using DentalVibe comfort system. giving maxillary infiltration dental local anesthesia with the aid of "DentalVibe comfort system" on one side of the maxillary arch prior extraction of primary molar tooth
Intervention: injection using DentalVibe comfort system (Device)
C group
Device: traditional dental injection giving maxillary infiltration dental local anesthesia without the aid of "DentalVibe comfort system" on the other side of the maxillary arch prior extraction of primary molar tooth
Intervention: traditional dental injection (Device)
Outcomes
Primary Outcomes
pain during injection
Time Frame: within 1 year
pain assessment using FLACC behavioral pain assessment (scale 0-10) and Wong-Baker FACES pain rating scale (scale 0-10) e 0: Relaxed and comfortable 1-3: Mild discomfort. 4-6: Moderate pain. 7-10: Severe discomfort or pain or both.
Secondary Outcomes
No secondary outcomes reported
Investigators
Muaaz Marwan halal
principal investigator
Cairo University