the Effect of Preoperative Sodium Ibuprofen on Postoperative Endodontic Pain

NCT04964622 | Completed Phase 1

• 1 other identifier: postoperative endodontic pain
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to clinically compare post-operative pain levels after administration of preoperative single dose of sodium ibuprofen versus placebo for patient with symptomatic irreversible pulpitis related to mandibular molar teeth.

Conditions

Irreversible Pulpitis

Outcome Measures

Primary Outcomes (1)

• postoperative pain

  pain will be measured by visual analogue scale(VAS). Postoperative pain levels were documented by the patients immediately after obturation, 6, 12, 24 and 48 hours post-treatment. The VAS consists a 10-cm line anchored by 2 extremes, ''no pain'' and ''pain as bad as it could be.'' Patients were asked to make a mark on the line that represents their level of perceived pain. Readings were transformed into categories; no pain (range of 0-4mm), mild pain (range of 5-44mm), moderate pain (range of 45-74mm) and severe pain (range of 75-100mm)

  Post-operative pain will be assessed immediately after treatment ,at 6 hours, at 12 hours, at 24 hours and 48 hours

Secondary Outcomes (1)

• need for rescue medication

  Amount of analgesics taken by the patient after root canal treatment, up to 48 hours postoperatively

Study Arms (2)

nurofen

OTHER

sodium ibuprofen 1 tablet (256) 30 minutes before treatment administered once (oral)

Drug: nurofen

placebo

PLACEBO COMPARATOR

starch tablet 30 minutes before treatment administered once (oral)

Drug: nurofen

Interventions

nurofen DRUG

tablet

Also known as: sodium ibuprofen

nurofen; placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients above 18 years old and below 66.
• Male or female
• Patients seeking root canal treatment
• Mandibular posterior molarteeth with Symptomatic irreversible pulpitis .
• Spontaneous pain
• Systematically healthy patient(ASA I,II)

You may not qualify if:

• Medically compromised patients having significant systemic disorders. (ASA III or IV)
• History of intolerance to NSAIDS.
• Patients with two or more adjacent teeth requiring endodontic treatment.
• External root resorption
• Internal root resorption
• Vertical root fracture
• Periapical lesion
• Pregnancy
• Use of ibuprofen in the last 12 hour
• Bleeding disorder
• Long term corticosteroid use
• Mobility Grade II or III.
• Pocket depth more than 5mm.
• Previous root canal therapy.
• Non-restorability

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, Egypt

Location

Related Publications (2)

• Smith EA, Marshall JG, Selph SS, Barker DR, Sedgley CM. Nonsteroidal Anti-inflammatory Drugs for Managing Postoperative Endodontic Pain in Patients Who Present with Preoperative Pain: A Systematic Review and Meta-analysis. J Endod. 2017 Jan;43(1):7-15. doi: 10.1016/j.joen.2016.09.010. Epub 2016 Dec 6.

  PMID: 27939729 RESULT

• Suresh N, Nagendrababu V, Koteeswaran V, Haritha JS, Swetha SD, Varghese A, Natanasabapathy V. Effect of preoperative oral administration of steroids in comparison to an anti-inflammatory drug on postoperative pain following single-visit root canal treatment - a double-blind, randomized clinical trial. Int Endod J. 2021 Feb;54(2):198-209. doi: 10.1111/iej.13416. Epub 2020 Nov 12.

  PMID: 32976660 RESULT

MeSH Terms

Interventions

Ibuprofen

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: drug will be put in sealed envelop and assistant supervisor will generate random sequence
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Model Details: patient with symptomatic irriversible pulpitis

Study Record Dates

• First Submitted: July 1, 2021
• First Posted: July 16, 2021
• Study Start: December 1, 2021
• Primary Completion: July 1, 2022
• Study Completion: September 1, 2022
• Last Updated: December 7, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)