Intraoperative Pain After Infiltration Technique Using Artpharma Versus Artinibsa in Children

Not Applicable

• Conditions: Pain, Postoperative
• Interventions: Other: Artpharma; Other: Artinibsa

• Registration Number: NCT04221685
• Lead Sponsor: Cairo University

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

Study Timeline

• Study First Submitted: 2020-01-01
• Study First Submitted QC: 2020-01-07
• Study First Posted: 2020-01-09
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-04
• Last Update Posted: 2020-10-08
• Study Start: 2020-12-01
• Primary Completion: 2021-12-01
• Study Completion: 2021-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 130

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Artpharma	Artpharma	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
Artinibsa	Artinibsa	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Onset of anesthesia.	Immediate	onset of anesthesia:is measuring by using stop watch and the unit is minutes
Pain during injection(success rate).	immediate	Pain during injection:is evaluated the success rate of anesthesia by using the visual analogue scale and measuring unite is categorical.
The sensation after injection.	Immediate	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).