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Comparative Evaluation Between the Effectiveness of Vibration Assisted Syringe and Conventional Syringe

Primary Purpose

Anxiety, Dental

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
vibraject
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety, Dental

Eligibility Criteria

4 Years - 6 Years (Child)All SexesAccepts Healthy Volunteers

inclusion criteria

  1. Cooperative patient. (rating 4 or 3 based on Frankl behavior scale).
  2. Children aging from 4 to 6 years
  3. Suffering from one or more deep carious lesions in their primary molars.
  4. Restorable primary molars

Exclusion Criteria:

  1. Medically compromised patients.
  2. Uncooperative children (rating 1 or 2 on the Frankl behavior scale) needing special line of treatment through general anesthesia.
  3. Signs and symptoms of irreversible pulpitis, spontaneous pain, necrosis or any signs and symptoms of abscess.
  4. Presence of any radiographic signs of abscess, bone loss, internal or external root resorption.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    study group

    control group

    Arm Description

    Group I (study group); children receiving intraoral injection of local anasethia using the vibration assisted syringe.

    Group II (control group): children receiving intraoral injection of local anasethia using the standard syringe.

    Outcomes

    Primary Outcome Measures

    Pain rating scale
    Visual linear analogue scale

    Secondary Outcome Measures

    anxiety
    Visual facial anxiety scale

    Full Information

    First Posted
    December 26, 2019
    Last Updated
    December 30, 2019
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04215055
    Brief Title
    Comparative Evaluation Between the Effectiveness of Vibration Assisted Syringe and Conventional Syringe
    Official Title
    Comparative Evaluation Between the Effectiveness of Vibration Assisted Syringe and Conventional Syringe in Decreasing Children Pain and Anxiety Perception During Local Anesthetic Injection ) Randomized Controlled Clinical Trial (
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 8, 2020 (Anticipated)
    Primary Completion Date
    February 2021 (Anticipated)
    Study Completion Date
    March 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    The study will be conducted to evaluate the effect of the vibration assisted syringe on pain perception and anxiety in children during intra oral injection of local anesthesia in comparison with conventional syringe.
    Detailed Description
    As for granted the main concern in pediatric dentistry is to guarantee a positive response from child for any further appointments, that's why we aim to manage a successful dental procedure keeping a stress free situation. Conventional local anesthetic technique is the most commonly used technique for anesthetizing teeth but in turn it has shown the highest levels of discomfort in comparison with other techniques. VibraJect is vibration associated syringe device, it is simple and cost effective solution to alleviate injection discomfort. It works because the light pressure of a Vibraject injection is carried rapidly to the brain by thicker insulated nerve tissues. In contrast, the needle prick travels on thinner nerve tissues, arriving too late for the brain to register the sensation. Vibraject is good news for the patient, because the anesthetic itself causes virtually no discomfort and good news for the dentist, who can work easily knowing that patient, is comfortable.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Anxiety, Dental

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    46 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    study group
    Arm Type
    Active Comparator
    Arm Description
    Group I (study group); children receiving intraoral injection of local anasethia using the vibration assisted syringe.
    Arm Title
    control group
    Arm Type
    Active Comparator
    Arm Description
    Group II (control group): children receiving intraoral injection of local anasethia using the standard syringe.
    Intervention Type
    Device
    Intervention Name(s)
    vibraject
    Intervention Description
    VibraJect; is a small battery-operated attachment that snaps on to the standard dental syringe. It delivers a high-frequency vibration to the needle which is strong enough for the patient to feel.
    Primary Outcome Measure Information:
    Title
    Pain rating scale
    Description
    Visual linear analogue scale
    Time Frame
    baseline
    Secondary Outcome Measure Information:
    Title
    anxiety
    Description
    Visual facial anxiety scale
    Time Frame
    baseline

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    4 Years
    Maximum Age & Unit of Time
    6 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    inclusion criteria Cooperative patient. (rating 4 or 3 based on Frankl behavior scale). Children aging from 4 to 6 years Suffering from one or more deep carious lesions in their primary molars. Restorable primary molars Exclusion Criteria: Medically compromised patients. Uncooperative children (rating 1 or 2 on the Frankl behavior scale) needing special line of treatment through general anesthesia. Signs and symptoms of irreversible pulpitis, spontaneous pain, necrosis or any signs and symptoms of abscess. Presence of any radiographic signs of abscess, bone loss, internal or external root resorption.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    mohamed abdallah
    Phone
    01122083204
    Email
    mohamedabdallah549@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    mohamed abdallah
    Organizational Affiliation
    Cairo University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    21406147
    Citation
    Roeber B, Wallace DP, Rothe V, Salama F, Allen KD. Evaluation of the effects of the VibraJect attachment on pain in children receiving local anesthesia. Pediatr Dent. 2011 Jan-Feb;33(1):46-50.
    Results Reference
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    PubMed Identifier
    23439049
    Citation
    Wilson S. Management of child patient behavior: quality of care, fear and anxiety, and the child patient. J Endod. 2013 Mar;39(3 Suppl):S73-7. doi: 10.1016/j.joen.2012.11.040.
    Results Reference
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    Comparative Evaluation Between the Effectiveness of Vibration Assisted Syringe and Conventional Syringe

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