Anesthetic Efficacy Of 4% ArtpharmaDent Versus 2% Mepecaine-L in Extraction of Lower First Primary Molars

NCT03942991 | Unknown

• 1 other identifier: 14422017496941
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

parallel technique will be done where the investigator (will be blinded) will give one type on anesthesia then performing the extraction and evaluating the intraoperative pain ,the same procedure will be done for the other type of anesthesia.

Conditions

Badly Decayed Lower First Primary Molars in Children

Outcome Measures

Primary Outcomes (1)

• Intra-Operative Pain during Extraction

  intraoperative pain will be measured using wong baker pain scale,The scale shows a series of faces ranging from a happy face at 0, or "no hurt", to a crying face at 10, which represents "hurts like the worst pain imaginable". Based on the faces and written descriptions, the patient chooses the face that best describes their level of pain Face

  Immediatly after etxraction

Study Arms (2)

2% Mepecaine-L

ACTIVE COMPARATOR

infiltration injection of 2% Mepivacaine

Drug: Mepivacaine 2% Injection

4% Artpharmadent

EXPERIMENTAL

infiltration injection of 4% Articaine

Drug: articaine

Interventions

articaine DRUG

infiltration injection of 4%artpharmadent

Also known as: Artpharmadent

4% Artpharmadent

Mepivacaine 2% Injection DRUG

infiltration injection of 2% Mepecaine-L

Also known as: 2% Mepecaine-L

2% Mepecaine-L

Eligibility Criteria

• Age: 6 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 6-8 years.
• Medically fit (ASA I, II).
• Mentally capable of communication.
• Having a mandibular first primary molar tooth that require Extraction.
• Child must give assent prior to participation, as well as parental informed written consent.
• Body weight \>20 kg.
• it should be the first dental treatment to the child

You may not qualify if:

• Medically and mentally compromised children.
• Children without a history of prolonged bleeding, platelet disorders, hypersensitivity,
• History of significant behavior management problems.
• Patients having active sites of pathosis in the area of injection.
• Patients who had taken analgesics or antibiotics in the 12-hrs preceding the injection.
• Patients allergic to Articaine and/or Mepivacaine and/or sulfur

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Interventions

Carticaine; Mepivacaine; Injections

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperidines; Drug Administration Routes; Drug Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 2, 2019
• First Posted: May 8, 2019
• Study Start: September 1, 2019
• Primary Completion: November 1, 2019
• Study Completion: December 1, 2019
• Last Updated: August 29, 2019

Record last verified: 2019-08