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出境医 / 临床实验 / Local Anesthesia With Needle-free Injection System (anesthesia)

Local Anesthesia With Needle-free Injection System (anesthesia)

Study Description
Brief Summary:
The purpose of this study was to compare the pain during needle insertion and injection in mandibular molars anesthetized with either traditional syringe (control) or Comfort in System (experimental).

Condition or disease Intervention/treatment Phase
Pediatric Anesthesia Local Anesthesia Device: Comfort-in injection system Other: conventional injection with dental needle Not Applicable

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparision of Injection Pain Caused by the 'Comfort in' Injection System Versus a Traditional Syringe for Inferior Alveolar Nerve Block Anaesthesia in Primary Teeth
Actual Study Start Date : June 1, 2018
Actual Primary Completion Date : May 15, 2019
Actual Study Completion Date : June 15, 2019
Arms and Interventions
Arm Intervention/treatment
Experimental: experimental
local anesthesia applyed with Comfort in system
Device: Comfort-in injection system
local anesthesia during dental treatment

Active Comparator: conventional injection
local anesthesia applyed with conventional syringe
Other: conventional injection with dental needle
for local anesthesia during dental treatment

Outcome Measures
Primary Outcome Measures :
  1. Wong-Baker Faces Pain Rating Scale (PRS) [ Time Frame: 1 year ]
    The PRS measures the unpleasantness or affective dimension of a child's pain experience and is used in children aged 3-17 years old. The PRS consists of a set of cartoon faces with varying facial expressions ranging from a smile/laughter to tears, and each child is asked to select the facial expression that best represents his/her experience of discomfort. Each face has a numerical value ranging from 0 (smiling face, "no hurt") to 5 (crying/screaming face, "hurts worst").

  2. Face, Legg, Cry, Consolability Scale (FLACC) [ Time Frame: 1 year ]
    The scale comprised the following parameters: (1) Face, (2) Legs, (3) Activity, (4) Cry, and (5) Consolability. Each of the five categories is scored from 0-2, which results in a minimum total score of 0 and maximumof 10. According to this scale: 0=Relaxed and comfortable (no pain); 1-3=Mild discomfort; 4-6=Moderate pain; and 7-10=Severe discomfort or pain [Willis et al., 2003]. Behavioural parameters were recorded.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • In need of treatment of right and left molar teeth of mandible,

    • Does not have any systemic disorder,
    • High level of communication that can provide logical answers to the questions we ask
    • With parental consent,
    • Volunteers who want to participate in the research
    • 6-12 years old patients who are compatible with routine dental treatments in the pediatric clinic

Exclusion Criteria:

  • No need for treatment of right and left molar teeth of mandible,
  • Has a systemic condition
  • Low level of communication that cannot provide reasonable answers to the questions we ask
  • Without parental consent
  • Do not want to participate voluntarily in the research
  • Do not attend a check-in
  • Patients not in the 6-12 age group
Contacts and Locations

Locations
Layout table for location information
Turkey
Okan University Faculty of Dentistry
Istanbul, Turkey, 34959
Sponsors and Collaborators
Sinem yildirim
Tracking Information
First Submitted Date  ICMJE July 11, 2019
First Posted Date  ICMJE July 22, 2019
Last Update Posted Date July 22, 2019
Actual Study Start Date  ICMJE June 1, 2018
Actual Primary Completion Date May 15, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 19, 2019)
  • Wong-Baker Faces Pain Rating Scale (PRS) [ Time Frame: 1 year ]
    The PRS measures the unpleasantness or affective dimension of a child's pain experience and is used in children aged 3-17 years old. The PRS consists of a set of cartoon faces with varying facial expressions ranging from a smile/laughter to tears, and each child is asked to select the facial expression that best represents his/her experience of discomfort. Each face has a numerical value ranging from 0 (smiling face, "no hurt") to 5 (crying/screaming face, "hurts worst").
  • Face, Legg, Cry, Consolability Scale (FLACC) [ Time Frame: 1 year ]
    The scale comprised the following parameters: (1) Face, (2) Legs, (3) Activity, (4) Cry, and (5) Consolability. Each of the five categories is scored from 0-2, which results in a minimum total score of 0 and maximumof 10. According to this scale: 0=Relaxed and comfortable (no pain); 1-3=Mild discomfort; 4-6=Moderate pain; and 7-10=Severe discomfort or pain [Willis et al., 2003]. Behavioural parameters were recorded.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
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 Local Anesthesia With Needle-free Injection System
Official Title  ICMJE Comparision of Injection Pain Caused by the 'Comfort in' Injection System Versus a Traditional Syringe for Inferior Alveolar Nerve Block Anaesthesia in Primary Teeth
Brief Summary The purpose of this study was to compare the pain during needle insertion and injection in mandibular molars anesthetized with either traditional syringe (control) or Comfort in System (experimental).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Pediatric Anesthesia
  • Local Anesthesia
Intervention  ICMJE
  • Device: Comfort-in injection system
    local anesthesia during dental treatment
  • Other: conventional injection with dental needle
    for local anesthesia during dental treatment
Study Arms  ICMJE
  • Experimental: experimental
    local anesthesia applyed with Comfort in system
    Intervention: Device: Comfort-in injection system
  • Active Comparator: conventional injection
    local anesthesia applyed with conventional syringe
    Intervention: Other: conventional injection with dental needle
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 Completed
Actual Enrollment  ICMJE
 (submitted: July 19, 2019)
60
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 15, 2019
Actual Primary Completion Date May 15, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • In need of treatment of right and left molar teeth of mandible,

    • Does not have any systemic disorder,
    • High level of communication that can provide logical answers to the questions we ask
    • With parental consent,
    • Volunteers who want to participate in the research
    • 6-12 years old patients who are compatible with routine dental treatments in the pediatric clinic

Exclusion Criteria:

  • No need for treatment of right and left molar teeth of mandible,
  • Has a systemic condition
  • Low level of communication that cannot provide reasonable answers to the questions we ask
  • Without parental consent
  • Do not want to participate voluntarily in the research
  • Do not attend a check-in
  • Patients not in the 6-12 age group
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 12 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04028271
Other Study ID Numbers  ICMJE 2018/201
Marmara universty ( Other Identifier: Ethical Committe )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Sinem yildirim, Okan University
Study Sponsor  ICMJE Sinem yildirim
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Okan University
Verification Date July 2019

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