Intraoperative Pain After Infiltration Technique Using Artpharma Versus Artinibsa in Children

Pain, Postoperative Clinical Trial

Official title:

Intraoperative Pain During Extraction of Maxillary Primary Molars Using Artpharma Versus Artinibsa in Children After Infiltration Technique: a Randomized Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04221685
• Other study ID #: IOP Use Artp Vs Artin inf
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 1, 2020
• Est. completion date: December 1, 2021

Study information

• Verified date: October 2020
• Source: Cairo University
• Contact: Hafedha Zain, Master
• Phone: 01114341678
• Email: hafedha.abdullah[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 130
• Est. completion date: December 1, 2021
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 9 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Other:
• 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
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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraoperative pain.	Intraoperative pain: is measuring by using Wong Baker visual analogue scale and measuring unite is Scale (0-10).	immediate
Secondary	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.	immediate
Secondary	Onset of anesthesia.	onset of anesthesia:is measuring by using stop watch and the unit is minutes	Immediate
Secondary	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).	Immediate