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

Sponsor
Cairo University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03942991
Collaborator
(none)
20
Enrollment
2
Arms
3
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Anesthetic Efficacy Of 4% ArtpharmaDent Versus 2% Mepecaine-L for Infilteration Anesthesia in Extraction of Badly Decayed Lower First Primary Molars: Pilot Study
Anticipated Study Start Date :
Sep 1, 2019
Anticipated Primary Completion Date :
Nov 1, 2019
Anticipated Study Completion Date :
Dec 1, 2019

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Intra-Operative Pain during Extraction [Immediatly after etxraction]

      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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Years to 8 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Cairo University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Nadeen Hossam Eldin Hosny Ahmed, Principal Investigator, Cairo University
    ClinicalTrials.gov Identifier:
    NCT03942991
    Other Study ID Numbers:
    • 14422017496941
    First Posted:
    May 8, 2019
    Last Update Posted:
    Aug 29, 2019
    Last Verified:
    Aug 1, 2019
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Mepivacaine
    Carticaine

    Study Results

    No Results Posted as of Aug 29, 2019