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
About this trial
This is an interventional treatment trial for Anxiety, Dental
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.
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
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
background
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
background
Learn more about this trial
Comparative Evaluation Between the Effectiveness of Vibration Assisted Syringe and Conventional Syringe
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