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

NCT03006107 | Unknown

• 1 other identifier: piroxicam _ Mepecaine
• Study Type: interventional
• Target: 26
• Locations: 0 countries
• Sites: N/A

Brief Summary

to evaluate the effect of a single intraligamentary injection of piroxicam on postoperative pain associated with endodontic procedures.

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

Outcome Measures

Primary Outcomes (1)

• 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.

  up to 48 hours

Study Arms (2)

intraligamentary injection of piroxicam

EXPERIMENTAL

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

Procedure: intraligamentary injection piroxicam

Intraligamentary mepevacaine

ACTIVE COMPARATOR

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.

Procedure: Intraligamentary mepevacaine

Interventions

intraligamentary injection piroxicam PROCEDURE

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

intraligamentary injection of piroxicam

Intraligamentary mepevacaine PROCEDURE

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.

Intraligamentary mepevacaine

Eligibility Criteria

• Age: 25 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Related Publications (10)

• 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.

  PMID: 8935018 BACKGROUND

• Pharmacological Strategies to Control Post-operative Endodontic Pain. Dental Research Journal (Vol. 4, No. 2, Autumn-Winter 2007

  BACKGROUND

• 3. Building effective strategies for the management of endodontic pain. Endodontic Topics 2002, 3, 93-105

  BACKGROUND

• 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.

  PMID: 22432824 BACKGROUND

• 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.

  PMID: 7005368 BACKGROUND

• 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.

  PMID: 3863874 BACKGROUND

• 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.

  PMID: 1940730 BACKGROUND

• 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.

  PMID: 21902704 BACKGROUND

• 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.

  PMID: 12148679 BACKGROUND

• 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.

  PMID: 3318443 BACKGROUND

Study Officials

• Angie g Ghoneim, Professor

  Department of endodontics - Faculty of Oral and Dental medicine - CU

  STUDY CHAIR

• marwa ga ahmed, student

  Department of endodontics - Faculty of Oral and Dental medicine - CU

  PRINCIPAL INVESTIGATOR

Central Study Contacts

marwa ga ahmed, student

CONTACT

01286171420; marwa.ahmed@dentistry.cu.edu.eg

Sherif A El khodary, Lecturer

CONTACT

01006609198

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: December 15, 2016
• First Posted: December 30, 2016
• Study Start: December 1, 2016
• Primary Completion: November 1, 2017
• Study Completion: January 1, 2018
• Last Updated: December 30, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share