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
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
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
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
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Intraoperative Pain After Infiltration Technique Using Artpharma Versus Artinibsa in Children
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