Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.

Condition or disease Intervention/treatment Phase
Dental Anxiety Device: injection using DentalVibe comfort system Device: traditional dental injection Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
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

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   6 Years to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Muaaz Hilal, DR 00201226090374 muaaz09@hotmail.com

Sponsors and Collaborators
Cairo University
Investigators
Layout table for investigator information
Study Director: Norhan El-dokky, PHD Cairo University
Layout table for additonal information
Responsible Party: Muaaz Marwan halal, principal investigator, Cairo University
ClinicalTrials.gov Identifier: NCT03033628    
Other Study ID Numbers: CEBC-CU-2017-01-06
First Posted: January 27, 2017    Key Record Dates
Last Update Posted: February 15, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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