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

Not Applicable

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

• Registration Number: NCT04303234
• Lead Sponsor: Cairo University

Brief 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.

Detailed 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.

Study Timeline

• Status Verified: 2020-03
• Study First Submitted: 2020-03-03
• Study First Submitted QC: 2020-03-10
• Last Update Submitted: 2020-03-10
• Study First Posted: 2020-03-11
• Last Update Posted: 2020-03-11
• Study Start: 2020-04-01
• Primary Completion: 2021-04-01
• Study Completion: 2021-10-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 46

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Artinibsa	Artinibsa	Powerful local anesthetic with short time for patients who can not tolerate normal doses of vasoconstrictor latency. High lipid solubility gives a better diffusion through the soft tissue and bone being very effective in infiltrative techniques. Duration: Latency time: 2 minutes Each mL contains: 4%Articaine 1:100000. Hydrochloride 40.00 mg, Epinephrine (D.C.I) 0.005 mg tartrate
Artpharma	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)

Primary Outcome Measures

Name	Time	Method
Intraoperative Pain: Wong Baker rating scale	During the procedure.	Measuring by using Wong Baker rating scale the measuring unite is :Scale (0-10) including six faces.

Secondary Outcome Measures

Name	Time	Method
Time of numbness disappear	2 hours postoperatively after the procedure.	Time of disappearance of numbness sensation by asking the parent/child and measuring is binary (Yes or No).
Onset of anesthesia	Immediately after the injection.	is measuring by using stop watch and the unite is minutes. the unit is : minutes
The sensation after injection	Immediately after the injection.	Evaluating the effect of the anesthesia by checking mucosa using the probe and measuring unite is binary (Yes or No)