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

NCT04303234 | Unknown

• 1 other identifier: CEBD-CU-2020-03-08
• Study Type: interventional
• Target: 46
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pain

Keywords

Articaine; Infiltration technique; Restoration primary teeth; Intraoperative pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Onset of anesthesia

  Immediately after the injection.

• The sensation after injection

  Immediately after the injection.

• Time of numbness disappear

  2 hours postoperatively after the procedure.

Study Arms (2)

Artinibsa

ACTIVE COMPARATOR

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

Artpharma

EXPERIMENTAL

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

Interventions

Artinibsa 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.

Artinibsa

Artpharma 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)

Artpharma

Eligibility Criteria

• Age: 8 Years - 10 Years
• Gender Eligibility Details: 8-10 years old
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 8-10 years old
• Mentally capable of communication
• Cooperative children need restorative treatment

You may not qualify if:

• Medically compromised patient
• Primary teeth requiring pulpotomy or pulpectomy
• Parent or guardians who refuse participating in the study

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Amani ALAidaros, Master

CONTACT

01004358665; amani.alaidaroos@dentistry.cu.edu.eg

Fatma Korany Ismail, Phd

CONTACT

fatmadent@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: single ( participant ) because the two interventions used in this trial are easily recognized by the investigator but the participant and the statistician will be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: March 3, 2020
• First Posted: March 11, 2020
• Study Start: April 1, 2020
• Primary Completion: April 1, 2021
• Study Completion: October 1, 2021
• Last Updated: March 11, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share