Piroxicam Premedication for Postendodontic Pain in Non-vital Mandibular Molars

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-01

Study Completion Date

2020-12-01

Brief Summary

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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.

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Detailed Description

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* 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.

Conditions

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Non-Vital Tooth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

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

Study Groups

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Piroxicam drug

20 mg piroxicam

Group Type EXPERIMENTAL

Piroxicam

Intervention Type DRUG

20mg piroxicam

Placebo

placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

placebo

Interventions

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Piroxicam

20mg piroxicam

Intervention Type DRUG

Placebo

placebo

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No