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Intraoperative Pain After Infiltration Technique Using Artpharma Versus Artinibsa in Children

Primary Purpose

Pain, Postoperative

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

About this trial

This is an interventional treatment trial for Pain, Postoperative focused on measuring Articaine, Extraction primary teeth, Infiltration technique, Postoperative pain, Intraoperative pain

Eligibility Criteria

6 Years - 9 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Children aged 6-9 years.
  • Children with maxillary primary molars indicated for extraction.

Exclusion Criteria:

  • Children with medical conditions.
  • Uncooperative children.
  • Parents or guardians who refuse participating in the study.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Artinibsa

    Artpharma

    Arm Description

    Powerful local anaesthetic with a short latency time. Its high lipid solubility gives it better diffusion through soft tissues and bone and makes it highly effective for infiltrative techniques.4%Articaine 1:100000.

    ArtPharma is a unique amide local anesthetic that is currently Used in dentistry Amides has taken over their predecessors esters with their enhanced performance.Each ml Articaine (D.C.I) 40.00 mg hydrochloride,Epinephrine (D.C.I) (tartrate) 0.01 mg

    Outcomes

    Primary Outcome Measures

    Intraoperative pain.
    Intraoperative pain: is measuring by using Wong Baker visual analogue scale and measuring unite is Scale (0-10).

    Secondary Outcome Measures

    Pain during injection(success rate).
    Pain during injection:is evaluated the success rate of anesthesia by using the visual analogue scale and measuring unite is categorical.
    Onset of anesthesia.
    onset of anesthesia:is measuring by using stop watch and the unit is minutes
    The sensation after injection.
    The sensation after injection: is evaluated the effect of the anesthesia by checking mucous using the probe and measuring unite is binary (Yes or No).

    Full Information

    First Posted
    January 1, 2020
    Last Updated
    October 4, 2020
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04221685
    Brief Title
    Intraoperative Pain After Infiltration Technique Using Artpharma Versus Artinibsa in Children
    Official Title
    Intraoperative Pain During Extraction of Maxillary Primary Molars Using Artpharma Versus Artinibsa in Children After Infiltration Technique: a Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    December 1, 2020 (Anticipated)
    Primary Completion Date
    December 1, 2021 (Anticipated)
    Study Completion Date
    December 1, 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 aim of this study is to assess Intraoperative pain for extraction of Maxillary primary molars using Artpharma Versus Artinibsa in children during infiltration technique.
    Detailed Description
    Articaine is used for pain control Like other local anesthetic drugs, articaine causes a temporary and completely reversible state of anesthesia (loss of sensation) during (dental) procedures.This local anesthesia was first synthesized by Rusching in 1969, and carried to the market in Germany by Hoechst AG, a life-sciences German company, under the brand name Ultracain ,it entered clinical practice in Germany in 1976. The name was changed in 1984, the year it was released in Canada. It then entered the United Kingdom in 1998, the United States in 2000 and Australia in 2005. At this time, articaine is available as a 4% solution containing 1:100, 000 or 1:200, 000 adrenaline. Articaine has been widely used in dental surgery.It started to use carticaine around 1977.In dentistry has been investigated widely. Articaine is a unique amide LA in that it contains a thiophene, instead of a benzene ring.The thiophene ring allows greater lipid solubility and effectiveness as a greater portion of an administered dose can enter neurons

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pain, Postoperative
    Keywords
    Articaine, Extraction primary teeth, Infiltration technique, Postoperative pain, Intraoperative pain

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Masking Description
    Single (Participant) single ( participant ) because the two interventions used in this trial are easily recognized by the investigator but the participant and the statistician will be blinded.
    Allocation
    Randomized
    Enrollment
    130 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Artinibsa
    Arm Type
    Active Comparator
    Arm Description
    Powerful local anaesthetic with a short latency time. Its high lipid solubility gives it better diffusion through soft tissues and bone and makes it highly effective for infiltrative techniques.4%Articaine 1:100000.
    Arm Title
    Artpharma
    Arm Type
    Experimental
    Arm Description
    ArtPharma is a unique amide local anesthetic that is currently Used in dentistry Amides has taken over their predecessors esters with their enhanced performance.Each ml Articaine (D.C.I) 40.00 mg hydrochloride,Epinephrine (D.C.I) (tartrate) 0.01 mg
    Intervention Type
    Other
    Intervention Name(s)
    Artpharma
    Intervention Description
    ArtPharma is a unique amide local anesthetic that is currently Used in dentistry Amides has taken over their predecessors esters with their enhanced performance.Each ml Articaine (D.C.I) 40.00 mg hydrochloride, Epinephrine (D.C.I) (tartrate) 0.01 mg
    Intervention Type
    Other
    Intervention Name(s)
    Artinibsa
    Intervention Description
    Powerful local anaesthetic with a short latency time. Its high lipid solubility gives it better diffusion through soft tissues and bone and makes it highly effective for infiltrative techniques.Each ml contains: Articaine (D.C.I) 40.00 mg hydrochloride, Epinephrine (D.C.I) (tartrate) 0.01 mg
    Primary Outcome Measure Information:
    Title
    Intraoperative pain.
    Description
    Intraoperative pain: is measuring by using Wong Baker visual analogue scale and measuring unite is Scale (0-10).
    Time Frame
    immediate
    Secondary Outcome Measure Information:
    Title
    Pain during injection(success rate).
    Description
    Pain during injection:is evaluated the success rate of anesthesia by using the visual analogue scale and measuring unite is categorical.
    Time Frame
    immediate
    Title
    Onset of anesthesia.
    Description
    onset of anesthesia:is measuring by using stop watch and the unit is minutes
    Time Frame
    Immediate
    Title
    The sensation after injection.
    Description
    The sensation after injection: is evaluated the effect of the anesthesia by checking mucous using the probe and measuring unite is binary (Yes or No).
    Time Frame
    Immediate

    10. Eligibility

    Sex
    All
    Gender Based
    Yes
    Gender Eligibility Description
    6-9years
    Minimum Age & Unit of Time
    6 Years
    Maximum Age & Unit of Time
    9 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Children aged 6-9 years. Children with maxillary primary molars indicated for extraction. Exclusion Criteria: Children with medical conditions. Uncooperative children. Parents or guardians who refuse participating in the study.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Hafedha Zain, Master
    Phone
    01114341678
    Email
    hafedha.abdullah@dentistry.cu.edu.eg
    First Name & Middle Initial & Last Name or Official Title & Degree
    Fatma Korany Ismail, Phd
    Email
    fatmadent@hotmail.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Intraoperative Pain After Infiltration Technique Using Artpharma Versus Artinibsa in Children

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