Piroxicam Premedication for Postendodontic Pain in Non-vital Mandibular Molars

Not Applicable

• Conditions: Non-Vital Tooth
• Interventions: Drug: Placebo; Drug: Piroxicam

• Registration Number: NCT03998826
• Lead Sponsor: Cairo University

Brief 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.

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.

Study Timeline

• Study First Submitted: 2019-06-25
• Study First Submitted QC: 2019-06-25
• Study First Posted: 2019-06-26
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-13
• Last Update Posted: 2019-07-16
• Study Start: 2019-09-01
• Primary Completion: 2020-09-01
• Study Completion: 2020-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	placebo
Piroxicam drug	Piroxicam	20 mg piroxicam

Primary Outcome Measures

Name	Time	Method
Postendodontic pain using a pain-measuring scale	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 Outcome Measures

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