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

Anesthetic Efficacy Of 4% ArtpharmaDent Versus 2% Mepecaine-L for Infilteration Anesthesia in Extraction of Badly Decayed Lower First Primary Molars: Pilot Study

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.

Study Overview

• Status: Unknown
• Conditions: Badly Decayed Lower First Primary Molars in Children
• Intervention / Treatment: Drug: Mepivacaine 2% Injection; Drug: articaine

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 8 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 2% Mepecaine-L; infiltration injection of 2% Mepivacaine	Drug: Mepivacaine 2% Injection; infiltration injection of 2% Mepecaine-L; Other Names: 2% Mepecaine-L
Experimental: 4% Artpharmadent; infiltration injection of 4% Articaine	Drug: articaine; infiltration injection of 4%artpharmadent; Other Names: Artpharmadent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2019
• Primary Completion (Anticipated): November 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: May 2, 2019
• First Submitted That Met QC Criteria: May 6, 2019
• First Posted (Actual): May 8, 2019

Study Record Updates

• Last Update Posted (Actual): August 29, 2019
• Last Update Submitted That Met QC Criteria: August 27, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Mepivacaine; Carticaine
• Other Study ID Numbers: 14422017496941

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No