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

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

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.

Study Overview

• Status: Unknown
• Conditions: Pain
• Intervention / Treatment: Other: Artinibsa; Other: Artpharma

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 Type: Interventional
• Enrollment (Anticipated): 46
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 10 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	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.
Experimental: 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)	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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Onset of anesthesia	is measuring by using stop watch and the unite is minutes. the unit is : minutes	Immediately after the injection.
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.
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.

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2020
• Primary Completion (Anticipated): April 1, 2021
• Study Completion (Anticipated): October 1, 2021

Study Registration Dates

• First Submitted: March 3, 2020
• First Submitted That Met QC Criteria: March 10, 2020
• First Posted (Actual): March 11, 2020

Study Record Updates

• Last Update Posted (Actual): March 11, 2020
• Last Update Submitted That Met QC Criteria: March 10, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Articaine; Infiltration technique; Restoration primary teeth; Intraoperative pain
• Other Study ID Numbers: CEBD-CU-2020-03-08

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No