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

Cairo University (CU)

Status: Unknown

Conditions: Pain

Treatments: Other: Artinibsa; Other: Artpharma

Study type: Interventional

Funder types: Other

Identifiers

NCT04303234

CEBD-CU-2020-03-08

Details and patient eligibility

About

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.

Full 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.

Enrollment: 46 estimated patients

Sex: All

Ages: 8 to 10 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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46 participants in 2 patient groups

Artinibsa

Active Comparator group

Description:

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

Treatment:

Other: Artinibsa

Artpharma

Experimental group

Description:

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)

Treatment:

Other: Artpharma