Effectiveness if Premedication With Single Dose Piroxicam and Prednisolone After a Single Visit Root Canal Treatment .

NCT04124822 | Completed Phase 2

• 1 other identifier: Dikiohs2013
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Two drugs (Piroxicam and Prednisolone)are being compared for post operative endodontic pain after a single visit root canal treatment for 74 hours.

Conditions

Post-operative Endodontic Pain

Outcome Measures

Primary Outcomes (1)

• post operative pain

  post operative pain will be measured after single visit endodontic treatment using visual analog scale with readings 1 to 10 from 24 hours till 76 hours

  76 hours

Study Arms (3)

control

NO INTERVENTION

group 1 , is no intervention group in which root canal procedure will be done without drug as ideal protocol .

Piroxicam

EXPERIMENTAL

group 2 is given Piroxicam 20 mg half an hour before root canal treatment to manage post operative pain.

Drug: Piroxicam 20 mg

Prednisolone

EXPERIMENTAL

group 3 is given Prednisolone 20mg half an hour before root canal treatment to manage post operative pain.

Drug: prednisolone 20 mg

Interventions

Piroxicam 20 mg DRUG

Piroxicm is from oxicam family of anti inflammatory drug that inhibits prostaglandin synthesis and effectively lower pain threshold levels

Piroxicam

prednisolone 20 mg DRUG

prednisolone is from steroid family of anti inflammatory drug that inhibit arachidonic acid and effectively lowers the pain

Prednisolone

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patient ages from 20-40 years(28).
• Single rooted tooth with symptomatic irreversible pulpitis.
• With no analgesic or anti-inflammatory drug taken within a week period before procedure.

You may not qualify if:

• Patients presenting with any systemic disease
• Patients already taking premedication for endodontic pain.
• Pregnant or lactating patients.
• Multirooted teeth.
• Teeth with Pulpal necrosis.
• Previously treated or initiated root canal treatment.
• Patient presenting with allergy due to drug

Sponsors & Collaborators

• Dow University of Health Sciences: lead

Study Sites (1)

DUHS

Karachi, Sindh, 75500, Pakistan

Location

Related Publications (1)

• Tanwir A, Ahmed S, Akhtar H, Wahid U, Shakoor Abbasi M, Ahmed N. Effectiveness of Single Dose Premedication of Piroxicam and Prednisolone on Post Endodontic Pain in One Visit Root Canal Treatment: A Randomized Clinical Trial. Eur Endod J. 2022 Oct;7(3):187-192. doi: 10.14744/eej.2022.24119.

  PMID: 36217645 DERIVED

MeSH Terms

Interventions

Piroxicam; Prednisolone

Intervention Hierarchy (Ancestors)

Thiazines; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Anum Tanwir, BDS

  Dow University of Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: It is a double blinded study in which investigator /caregiver and participant will be blinded and 3rd person not in the study will be dispatching drugs from the coded bottles .
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MDS trainee (operative dentistry)

Model Details: subjects are randomly placed into one of the three groups: Placebo, Piroxicam (20 mg), Prednisolone (20 mg). The drugs will be given thirty minutes before procedure starts,followed by one visit root canal procedure. Postoperative pain will be evaluated up to 96 hours interval using a visual analog scale.

Study Record Dates

• First Submitted: August 19, 2019
• First Posted: October 11, 2019
• Study Start: May 30, 2018
• Primary Completion: July 15, 2019
• Study Completion: July 15, 2019
• Last Updated: October 11, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)