Piroxicam Premedication for Postendodontic Pain in Non-vital Mandibular Molars

Non-Vital Tooth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03998826
• Other study ID #: CEBD-CU-2019-06-13
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2019
• Est. completion date: December 1, 2020

Study information

• Verified date: July 2019
• Source: Cairo University
• Contact: Asmaa FE Mhamed, B.D.S
• Phone: +201273035494
• Email: logainali89[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 1, 2020
• Est. primary completion date: September 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Non-Vital Tooth
• Tooth, Nonvital

Intervention

Drug:
• Piroxicam
20mg piroxicam
• Placebo
placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postendodontic pain using a pain-measuring scale	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	6 hours
Primary	Postendodontic pain using a pain-measuring scale	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	12 hours
Primary	Postendodontic pain using a pain-measuring scale	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	24 hours
Primary	Postendodontic pain using a pain-measuring scale	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	48 hours
Primary	Postendodontic pain using a pain-measuring scale	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	72 hours
Primary	Postendodontic pain using a pain-measuring scale	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	7 days
Secondary	Analgesic medication intake incidence	Analgesic medication intake incidence (Yes/No) as a rescue medication in case postoperative pain persisted after the sham medication intake.	7 days