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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03998826
Other study ID # CEBD-CU-2019-06-13
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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