Pain Perception of Dental Local Anesthesia Using "DentalVibe Comfort System" in a Group of Egyptian Children
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03033628|
Recruitment Status : Unknown
Verified February 2017 by Muaaz Marwan halal, Cairo University.
Recruitment status was: Not yet recruiting
First Posted : January 27, 2017
Last Update Posted : February 15, 2017
|Condition or disease||Intervention/treatment||Phase|
|Dental Anxiety||Device: injection using DentalVibe comfort system Device: traditional dental injection||Not Applicable|
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.
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 examination using mirror and probe to assess inclusion criteria. Before initiating the treatment, the site of the injection will be dried then prepped with antiseptic solution swab, then a topical anaesthetic agent (topical anesthetics 20% benzocaine) will be applied with a cotton tip applicator for 60 sec.
Demonstration will be performed by putting the device into direct contact with the children's nails before applying the device intraorally.
The cheek will be retracted and the device will be turned on.
1mL of local anesthetic solution (articaine hypochloride 4% with 1:100.000 epinephrine, Septodont) will be injected using a 27 gauge needle which will be delivered over 1 min.
AS that of the intervention group except, the device will be used only as a cheek retractor during the injection, but will be turned off.
Objective assessment will be performed by observing the patients behavior using the FLAAC scale during the anesthetic injection and needle insertion.
Subjective evaluation will be obtained using the Wong-Baker FACES pain rating scale.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||21 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Estimated Study Start Date :||April 1, 2017|
|Estimated Primary Completion Date :||June 1, 2017|
|Estimated Study Completion Date :||January 1, 2018|
Experimental: 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
Device: injection using DentalVibe comfort system
giving maxillary infiltration injection of dental local anesthesia using DentalVibe comfort system.
Active Comparator: 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
Device: traditional dental injection
giving maxillary infiltration injection of dental local anesthesia without using DentalVibe comfort system.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03033628
|Contact: Muaaz Hilal, DRemail@example.com|
|Study Director:||Norhan El-dokky, PHD||Cairo University|