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

NCT ID: NCT04303234

Last Updated: 2020-03-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-01
• Study Completion Date: 2021-10-01

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.

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Artinibsa

Intervention Type: OTHER

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)

Group Type: EXPERIMENTAL

Artpharma

Intervention Type: OTHER

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)

Interventions

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.

Intervention Type: OTHER

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)

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Amani Hamed Hashem AL-Aidaros

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Amani ALAidaros, Master

Role: CONTACT

amani.alaidaroos@dentistry.cu.edu.eg

01004358665

Fatma Korany Ismail, Phd

Role: CONTACT

fatmadent@hotmail.com

Other Identifiers

CEBD-CU-2020-03-08

Identifier Type: -

Identifier Source: org_study_id