Piroxicam Premedication for Postendodontic Pain in Non-vital Mandibular Molars

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03998826

Enrollment

Registered

2019-06-26

Start date

2019-09-01

Completion date

2020-12-01

Last updated

2019-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Vital Tooth

Keywords

Piroxicam, Postendodontic pain, analgesic intake

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.

Interventions

DRUGPiroxicam

20mg piroxicam

DRUGPlacebo

placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

The study will be participant and operator-blind where the participant and operator will not know the intervention done.

Intervention model description

Parallel Assignment Type: Two arm, parallel, randomized clinical trial. Allocation ratio: 1:1 Framework: Superiority.

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Postendodontic pain using a pain-measuring scale	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

Secondary

Measure	Time frame	Description
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.

Contacts

Primary ContactAsmaa FE Mhamed, B.D.S

logainali89@hotmail.com+201273035494

Backup ContactSuzan AW Amin, Ph.D

swaness@rocketmail.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026