Piroxicam Premedication for Postendodontic Pain in Non-vital Mandibular Molars

Overview

The aim of the study is to evaluate the effect of piroxicam (20mg) compared to placebo on post-endodontic pain of single-visit endodontic treatment of non-vital mandibular molars.

Full Title of Study: “Effect of Piroxicam Premedication on Postendodontic Pain in Mandibular Molars With Non-vital Pulp: A Randomized Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: September 1, 2020

Detailed Description

– Patients will be clinically and radiographically examined and their eligibility will be assessed. Eligible patients will be treated in one visit. – Patients will be randomly assigned to one of 2 groups: experimental group (premedication with 20 mg of piroxicam) and the control group (premedication with placebo). Each participant will receive a standard inferior alveolar nerve block injection. After endodontic treatment, patients will be given postoperative instructions and informed, in case of pain, to receive ibuprofen 200 mg as rescue medication. – Postendodontic pain intensity and incidence at the different pain categories (No, mild, moderate, severe) will be assessed 6, 12, 24, 48, 72 hours and 7 days postoperatively using a 0-10 numerical rate scale (NRS). Analgesic intake throughout the 7 days will be recorded.

Interventions

  • Drug: Piroxicam
    • 20mg piroxicam
  • Drug: Placebo
    • placebo

Arms, Groups and Cohorts

  • Experimental: Piroxicam drug
    • 20 mg piroxicam
  • Placebo Comparator: Placebo
    • placebo

Clinical Trial Outcome Measures

Primary Measures

  • Postendodontic pain using a pain-measuring scale
    • Time Frame: 6 hours
    • Postoperative pain is measured using the Numerical Rating Scale (NRS) which is an 11-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured 6 hours after the first visit
  • Postendodontic pain using a pain-measuring scale
    • Time Frame: 12 hours
    • Postoperative pain is measured using the Numerical Rating Scale (NRS) which is an 11-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured 12 hours after the first visit
  • Postendodontic pain using a pain-measuring scale
    • Time Frame: 24 hours
    • Postoperative pain is measured using the Numerical Rating Scale (NRS) which is an 11-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured 24 hours after the first visit
  • Postendodontic pain using a pain-measuring scale
    • Time Frame: 48 hours
    • Postoperative pain is measured using the Numerical Rating Scale (NRS) which is an 11-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured 48 hours after the first visit
  • Postendodontic pain using a pain-measuring scale
    • Time Frame: 72 hours
    • Postoperative pain is measured using the Numerical Rating Scale (NRS) which is an 11-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured 72 hours after the first visit
  • Postendodontic pain using a pain-measuring scale
    • Time Frame: 7 days
    • Postoperative pain is measured using the Numerical Rating Scale (NRS) which is an 11-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured 7 days after the first visit

Secondary Measures

  • Analgesic medication intake incidence
    • Time Frame: 7 days
    • Analgesic medication intake incidence (Yes/No) as a rescue medication in case postoperative pain persisted after the sham medication intake.

Participating in This Clinical Trial

Inclusion Criteria

1. Patients aging between 18-50 years old 2. Patients with mandibular molar with non-vital pulp. 3. Systemically- healthy patients (ASA I or II). 4. Patients who agree to attend for recall appointments and provide a written consent. Exclusion Criteria:

1. Pregnant or lactating female patients. 2. Patients allergic to piroxicam. 3. History of peptic ulceration. 4. Periapical abscess, fistula. 5. Non-restorable teeth. 6. Moderate or severe marginal periodontitis i.e. pocket probe>3mm.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 50 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Cairo University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Asmaa Fathelrahman Mohamed, Postgraduate Student, Department of Endodontics, Faculty of Dentistry, Cairo University – Cairo University
  • Overall Official(s)
    • Asmaa FE Mohamed, B.D.S, Principal Investigator, Cairo University
  • Overall Contact(s)
    • Asmaa FE Mhamed, B.D.S, +201273035494, logainali89@hotmail.com

References

Konagala RK, Mandava J, Pabbati RK, Anupreeta A, Borugadda R, Ravi R. Effect of pretreatment medication on postendodontic pain: A double-blind, placebo-controlled study. J Conserv Dent. 2019 Jan-Feb;22(1):54-58. doi: 10.4103/JCD.JCD_135_18.

Joshi N, Mathew S, George JV, Hegde S, Bhandi S, Madhu KS. Comparative evaluation of the efficacy of two modes of delivery of Piroxicam (Dolonex(®)) for the management of postendodontic pain: A randomized control trial. J Conserv Dent. 2016 Jul-Aug;19(4):301-5. doi: 10.4103/0972-0707.186454.

Nekoofar MH, Sadeghipanah M, Dehpour AR. Evaluation of meloxicam (A cox-2 inhibitor) for management of postoperative endodontic pain: a double-blind placebo-controlled study. J Endod. 2003 Oct;29(10):634-7.

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.