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Clinical Trials/NCT04303234
NCT04303234
Unknown
Not Applicable

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

Cairo University0 sites46 target enrollmentApril 1, 2020
ConditionsPain

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pain
Sponsor
Cairo University
Enrollment
46
Primary Endpoint
Intraoperative Pain: Wong Baker rating scale
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 1, 2020
End Date
October 1, 2021
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Amani Hamed Hashem AL-Aidaros

Principle Investigator

Cairo University

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

Outcomes

Primary Outcomes

Intraoperative Pain: Wong Baker rating scale

Time Frame: During the procedure.

Measuring by using Wong Baker rating scale the measuring unite is :Scale (0-10) including six faces.

Secondary Outcomes

  • Time of numbness disappear(2 hours postoperatively after the procedure.)
  • Onset of anesthesia(Immediately after the injection.)
  • The sensation after injection(Immediately after the injection.)

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