Clinical trial NCT03006107: 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
Overall status: UNKNOWN
Phase: NA
Conditions: 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
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2016-12-30
Enrollment: 26
Sex: ALL
Minimum age (years): 25
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: 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.
timeFrame: up to 48 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Department of endodontics - Faculty of Oral and Dental medicine - CU
name: Angie g Ghoneim, Professor
role: STUDY_CHAIR
affiliation: Department of endodontics - Faculty of Oral and Dental medicine - CU
name: marwa ga ahmed, student
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: Pharmacological Strategies to Control Post-operative Endodontic Pain. Dental Research Journal (Vol. 4, No. 2, Autumn-Winter 2007
citation: 3. Building effective strategies for the management of endodontic pain. Endodontic Topics 2002, 3, 93-105
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.
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.
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.
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.
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.
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.
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.