Pain Perception of Dental Local Anesthesia Using "DentalVibe Comfort System" in a Group of Egyptian Children
NCT ID: NCT03033628
Last Updated: 2017-02-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
21 participants
INTERVENTIONAL
2017-04-01
2018-01-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
NONE
Study Groups
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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
injection using DentalVibe comfort system
giving maxillary infiltration injection of dental local anesthesia using DentalVibe comfort system.
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
traditional dental injection
giving maxillary infiltration injection of dental local anesthesia without using DentalVibe comfort system.
Interventions
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injection using DentalVibe comfort system
giving maxillary infiltration injection of dental local anesthesia using DentalVibe comfort system.
traditional dental injection
giving maxillary infiltration injection of dental local anesthesia without using DentalVibe comfort system.
Eligibility Criteria
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Inclusion Criteria
2. Apparently healthy Children.
3. Cooperative children.
4. Children with carious maxillary bilateral primary molars indicated for extraction.
Exclusion Criteria
2. Children with Neurologic disorders.
3. Children with mental disability.
4. Presence of periapical or gingival legion.
5. Severe Gingivitis.
6 Years
7 Years
ALL
Yes
Sponsors
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Cairo University
OTHER
Responsible Party
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Muaaz Marwan halal
principal investigator
Principal Investigators
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Norhan El-dokky, PHD
Role: STUDY_DIRECTOR
Cairo University
Central Contacts
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Other Identifiers
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CEBC-CU-2017-01-06
Identifier Type: -
Identifier Source: org_study_id
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