An interventional study of injection using DentalVibe comfort system and traditional dental injection in Dental Anxiety, sponsored by Cairo University. Status unknown. Open to participants aged 6 Years to 7 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-02-15.
Sponsored by Cairo University · Not applicable, Interventional, and Other
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.
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:
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.
Control group:
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.
Assessment:
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.
Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.
Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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 using DentalVibe comfort system.
giving maxillary infiltration injection of dental local anesthesia without using DentalVibe comfort system.
pain during injection
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.
Time frame: within 1 year
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.
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Cairo University