Assess Intraoperative Pain for Restorative Treatment of Maxillary 1st Permanent Molars Using Artinibsa Versus Artpharma in Children During Infiltration Technique

Pain Clinical Trial

Official title:

Intraoperative Pain During Restorative Treatment Of Maxillary First Permanent Molars Using Artinibsa Versus Artpharma In Children After Infiltration Technique: A Randomized Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04303234
• Other study ID #: CEBD-CU-2020-03-08
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2020
• Est. completion date: October 1, 2021

Study information

• Verified date: March 2020
• Source: Cairo University
• Contact: Amani ALAidaros, Master
• Phone: 01004358665
• Email: amani.alaidaroos[@]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 restorative treatment of Maxillary First Permanent Molars using Artinibsa Versus Artpharma in children during infiltration technique.

Description:

Local anesthesia is very important during dental procedure because it's a temporary loss of sensation which will lead to decrease the pain. Local anesthesia started with discovery of Cocaine in 1860. Followed by developments of Novocaine 1904 and lignocaine in 1942 by Lofgren. It became the gold standard drug compared to other local anesthetic. Later, several new drugs were discovered such as:Bupivacaine, Articaine, Mepivicaine etc. Articaine Hydrochloride (HCL) was available in Germany since 1976. It's the only amide local anesthesia containing ester group in its molecular structure leading to metabolizing of the drug by both plasma esterases and liver microsomal enzymes, the clinical efficacy and advantages of articaine is the duration of its anesthetic effect and its superior diffusion through the bony tissue.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 46
• Est. completion date: October 1, 2021
• Est. primary completion date: April 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 10 Years

Eligibility

Inclusion Criteria:

• Children aged 8-10 years old

• Mentally capable of communication

• Cooperative children need restorative treatment

Exclusion Criteria:

• Medically compromised patient

• Primary teeth requiring pulpotomy or pulpectomy

• Parent or guardians who refuse participating in the study

Related Conditions & MeSH terms

• Pain

Intervention

Other:
• Artinibsa
local anaesthetic solution 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 4%Articaine 1:100000.
• Artpharma
Its a special amide local anesthetic contain 4% articaine with epinephrine 1/200000 as a vasoconstrictor ,Contains only sulfite as a stabilizer (max 0.31 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: Wong Baker rating scale	Measuring by using Wong Baker rating scale the measuring unite is :Scale (0-10) including six faces.	During the procedure.
Secondary	Onset of anesthesia	is measuring by using stop watch and the unite is minutes. the unit is : minutes	Immediately after the injection.
Secondary	The sensation after injection	Evaluating the effect of the anesthesia by checking mucosa using the probe and measuring unite is binary (Yes or No)	Immediately after the injection.
Secondary	Time of numbness disappear	Time of disappearance of numbness sensation by asking the parent/child and measuring is binary (Yes or No).	2 hours postoperatively after the procedure.