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Pain Perception of Dental Local Anesthesia Using "DentalVibe Comfort System" in a Group of Egyptian Children

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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
Sponsor:
Information provided by (Responsible Party):
Muaaz Marwan halal, Cairo University

Tracking Information
First Submitted Date  ICMJE January 22, 2017
First Posted Date  ICMJE January 27, 2017
Last Update Posted Date February 15, 2017
Estimated Study Start Date  ICMJE April 1, 2017
Estimated Primary Completion Date June 1, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 14, 2017)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 26, 2017)
  • pain during injection [ Time Frame: within 1 year ]
    Objective pain assessment using FLACC behavioral pain assessment (scale 0-10) 0: Relaxed and comfortable 1-3: Mild discomfort. 4-6: Moderate pain. 7-10: Severe discomfort or pain or both.
  • pain during injection [ Time Frame: within 1 year ]
    Subjective pain assessment using Wong-Baker FACES pain rating scale (scale 0-10) 0: No hurts. 2: Hurts a little bit. 4: Hurts a little more. 6: Hurts even more. 8: Hurts whole lot. 10: Hurts worst.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pain Perception of Dental Local Anesthesia Using "DentalVibe Comfort System" in a Group of Egyptian Children
Official Title  ICMJE 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
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:

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Dental Anxiety
Intervention  ICMJE
  • Device: injection using DentalVibe comfort system
    giving maxillary infiltration injection of dental local anesthesia using DentalVibe comfort system.
  • Device: traditional dental injection
    giving maxillary infiltration injection of dental local anesthesia without using DentalVibe comfort system.
Study Arms  ICMJE
  • 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
    Intervention: Device: injection 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
    Intervention: Device: traditional dental injection
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: January 26, 2017)
21
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 1, 2018
Estimated Primary Completion Date June 1, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Healthy children aged 6-7 years old.
  2. Apparently healthy Children.
  3. Cooperative children.
  4. Children with carious maxillary bilateral primary molars indicated for extraction.

Exclusion Criteria:

  1. Children who are allergic to amide group.
  2. Children with Neurologic disorders.
  3. Children with mental disability.
  4. Presence of periapical or gingival legion.
  5. Severe Gingivitis.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 7 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03033628
Other Study ID Numbers  ICMJE CEBC-CU-2017-01-06
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Muaaz Marwan halal, Cairo University
Study Sponsor  ICMJE Cairo University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Norhan El-dokky, PHD Cairo University
PRS Account Cairo University
Verification Date February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP