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Comparison of a Prophylactic Intraligamentary Injection of Piroxicam Versus Mepecaine of Post-endodontic Pain

Primary Purpose

Pulpitis - Irreversible

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
intraligamentary injection piroxicam
Intraligamentary mepevacaine
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulpitis - Irreversible focused on measuring Irreversible pulpitis, Post endodontic pain, Symptomatic pulpitis pain, Single visit RCT pain, Root canal treatment flare up, Single dose piroxicam, Intraligamentary piroxicam, Intraligamentary mepecaine

Eligibility Criteria

25 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • • Medically free patients

    • Patient's age between 25-50 years.
    • Molar or premolar teeth diagnosed clinically and radiographically with irreversible pulpitis and symptomatic apical periodontitis.
    • Positive patient's acceptance for participation in the study.
    • Sex include both male and female.
    • Patients who can understand Numerical Rating Scale (NRS)
    • Patients able to sign informed consent.

Exclusion Criteria:

  • • Pregnancy or lactation in female patients

    • Medically compromised patients.
    • Patient with multiple teeth that required endodontic treatment to eliminate the possibility of pain referral.
    • Patient with fracture or mobile or mutilated teeth.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    intraligamentary injection of piroxicam

    Intraligamentary mepevacaine

    Arm Description

    intraligamentary injection Piroxicam is another NSAID that which has the ability for the treatment of pain, fever and inflammation in the body , has a half-life of 50h in the plasma , oral piroxicam reaches a peak concentration in the plasma within 2 to 4 hours . The needle will be placed in the gingival sulcus at a 30- degree angle to the long axis of the tooth then apical pressure is applied until the needle wedged into the periodontal ligament between the tooth and the alveolar crest of the bone

    mepevacaine is an anesthetic (numbing medicine) that blocks the nerve impulses that send pain signals to brain . It is also used as an anesthetic for dental procedures.

    Outcomes

    Primary Outcome Measures

    The degree of postoperative pain at 6, 12, 24 and 48 postoperative hours which will be measured by Numeric Rate Scale , where the patient will be asked to rate the progress of pain on the NRS and inform the investigator with the results.
    Primary outcome will be collected by the operator through Numerical Rating Scale (NRS)20 which is an 11-point scale consisting of numbers from 0 through 10; 0 reading represents "no pain" , 1- 3 readings represent "mild pain" , 4- 6 readings represent "moderate pain" , 7- 10 readings represent "severe pain" No or mild pain will be considered as success while moderate or severe pain will be regarded as failure.

    Secondary Outcome Measures

    Full Information

    First Posted
    December 15, 2016
    Last Updated
    December 27, 2016
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03006107
    Brief Title
    Comparison of a Prophylactic Intraligamentary Injection of Piroxicam Versus Mepecaine of Post-endodontic Pain
    Official Title
    Comparison of the Efficacy of Prophylactic Intraligamentary Injection of Piroxicam Versus Mepecaine for Management of Post-endodontic Pain in Posterior Teeth
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    December 2016 (undefined)
    Primary Completion Date
    November 2017 (Anticipated)
    Study Completion Date
    January 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    to evaluate the effect of a single intraligamentary injection of piroxicam on postoperative pain associated with endodontic procedures.
    Detailed Description
    The pain after endodontic treatment is commonly severe in the first 24 hours after treatment, then it will reduce gradually until commonly disappearing after 7-10 days in most cases. Since piroxicam has a half-life of 50 hours in the plasma, it will be effective in controlling the most intense pain which occurs after endodontic treatment It appears that optimal clinical benefits can be achieved by administering drugs such as local anesthetics and NSAIDs before the onset of postoperative pain. Administering these drugs before a surgical or an endodontic procedure may be of benefit for longer procedures or for minimizing peripheral sensitization, which is a result of the cascade of inflammatory mediators that are released by tissue injury and fuel the subsequent inflammatory process

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pulpitis - Irreversible
    Keywords
    Irreversible pulpitis, Post endodontic pain, Symptomatic pulpitis pain, Single visit RCT pain, Root canal treatment flare up, Single dose piroxicam, Intraligamentary piroxicam, Intraligamentary mepecaine

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    26 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    intraligamentary injection of piroxicam
    Arm Type
    Experimental
    Arm Description
    intraligamentary injection Piroxicam is another NSAID that which has the ability for the treatment of pain, fever and inflammation in the body , has a half-life of 50h in the plasma , oral piroxicam reaches a peak concentration in the plasma within 2 to 4 hours . The needle will be placed in the gingival sulcus at a 30- degree angle to the long axis of the tooth then apical pressure is applied until the needle wedged into the periodontal ligament between the tooth and the alveolar crest of the bone
    Arm Title
    Intraligamentary mepevacaine
    Arm Type
    Active Comparator
    Arm Description
    mepevacaine is an anesthetic (numbing medicine) that blocks the nerve impulses that send pain signals to brain . It is also used as an anesthetic for dental procedures.
    Intervention Type
    Procedure
    Intervention Name(s)
    intraligamentary injection piroxicam
    Intervention Description
    intraligamentary injection Piroxicam is another NSAID that which has the ability for the treatment of pain, fever and inflammation in the body , has a half-life of 50h in the plasma , oral piroxicam reaches a peak concentration in the plasma within 2 to 4 hours . The needle will be placed in the gingival sulcus at a 30- degree angle to the long axis of the tooth then apical pressure is applied until the needle wedged into the periodontal ligament between the tooth and the alveolar crest of the bone
    Intervention Type
    Procedure
    Intervention Name(s)
    Intraligamentary mepevacaine
    Intervention Description
    mepevacaine is an anesthetic (numbing medicine) that blocks the nerve impulses that send pain signals to brain . It is also used as an anesthetic for dental procedures.
    Primary Outcome Measure Information:
    Title
    The degree of postoperative pain at 6, 12, 24 and 48 postoperative hours which will be measured by Numeric Rate Scale , where the patient will be asked to rate the progress of pain on the NRS and inform the investigator with the results.
    Description
    Primary outcome will be collected by the operator through Numerical Rating Scale (NRS)20 which is an 11-point scale consisting of numbers from 0 through 10; 0 reading represents "no pain" , 1- 3 readings represent "mild pain" , 4- 6 readings represent "moderate pain" , 7- 10 readings represent "severe pain" No or mild pain will be considered as success while moderate or severe pain will be regarded as failure.
    Time Frame
    up to 48 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    25 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: • Medically free patients Patient's age between 25-50 years. Molar or premolar teeth diagnosed clinically and radiographically with irreversible pulpitis and symptomatic apical periodontitis. Positive patient's acceptance for participation in the study. Sex include both male and female. Patients who can understand Numerical Rating Scale (NRS) Patients able to sign informed consent. Exclusion Criteria: • Pregnancy or lactation in female patients Medically compromised patients. Patient with multiple teeth that required endodontic treatment to eliminate the possibility of pain referral. Patient with fracture or mobile or mutilated teeth.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    marwa ga ahmed, student
    Phone
    01286171420
    Email
    marwa.ahmed@dentistry.cu.edu.eg
    First Name & Middle Initial & Last Name or Official Title & Degree
    Sherif A El khodary, Lecturer
    Phone
    01006609198
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Angie g Ghoneim, Professor
    Organizational Affiliation
    Department of endodontics - Faculty of Oral and Dental medicine - CU
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    marwa ga ahmed, student
    Organizational Affiliation
    Department of endodontics - Faculty of Oral and Dental medicine - CU
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    8935018
    Citation
    Penniston SG, Hargreaves KM. Evaluation of periapical injection of Ketorolac for management of endodontic pain. J Endod. 1996 Feb;22(2):55-9. doi: 10.1016/S0099-2399(96)80272-X.
    Results Reference
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    Citation
    Pharmacological Strategies to Control Post-operative Endodontic Pain. Dental Research Journal (Vol. 4, No. 2, Autumn-Winter 2007
    Results Reference
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    Citation
    3. Building effective strategies for the management of endodontic pain. Endodontic Topics 2002, 3, 93-105
    Results Reference
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    PubMed Identifier
    22432824
    Citation
    Atbaei A, Mortazavi N. Prophylactic intraligamentary injection of piroxicam (feldene) for the management of post-endodontic pain in molar teeth with irreversible pulpitis. Aust Endod J. 2012 Apr;38(1):31-5. doi: 10.1111/j.1747-4477.2010.00274.x. Epub 2010 Oct 24.
    Results Reference
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    PubMed Identifier
    7005368
    Citation
    Torabinejad M, Bakland LK. Prostaglandins: their possible role in the pathogenesis of pulpal and periapical diseases, part 2. J Endod. 1980 Oct;6(10):769-76. doi: 10.1016/S0099-2399(80)80107-5. No abstract available.
    Results Reference
    background
    PubMed Identifier
    3863874
    Citation
    Cohen JS, Reader A, Fertel R, Beck M, Meyers WJ. A radioimmunoassay determination of the concentrations of prostaglandins E2 and F2alpha in painful and asymptomatic human dental pulps. J Endod. 1985 Aug;11(8):330-5. doi: 10.1016/s0099-2399(85)80039-x. No abstract available.
    Results Reference
    background
    PubMed Identifier
    1940730
    Citation
    McNicholas S, Torabinejad M, Blankenship J, Bakland L. The concentration of prostaglandin E2 in human periradicular lesions. J Endod. 1991 Mar;17(3):97-100. doi: 10.1016/S0099-2399(06)81737-1.
    Results Reference
    background
    PubMed Identifier
    21902704
    Citation
    Mehrvarzfar P, Abbott PV, Saghiri MA, Delvarani A, Asgar K, Lotfi M, Karamifar K, Kharazifard MJ, Khabazi H. Effects of three oral analgesics on postoperative pain following root canal preparation: a controlled clinical trial. Int Endod J. 2012 Jan;45(1):76-82. doi: 10.1111/j.1365-2591.2011.01950.x. Epub 2011 Sep 8.
    Results Reference
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    PubMed Identifier
    12148679
    Citation
    Mehlisch DR. The efficacy of combination analgesic therapy in relieving dental pain. J Am Dent Assoc. 2002 Jul;133(7):861-71. doi: 10.14219/jada.archive.2002.0300.
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    PubMed Identifier
    3318443
    Citation
    Maccagno A, Di Giorgio EE, Caston OL, Sagasta CL. Double-blind controlled clinical trial of oral S-adenosylmethionine versus piroxicam in knee osteoarthritis. Am J Med. 1987 Nov 20;83(5A):72-7. doi: 10.1016/0002-9343(87)90855-2.
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    Comparison of a Prophylactic Intraligamentary Injection of Piroxicam Versus Mepecaine of Post-endodontic Pain

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