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the Effect of Preoperative Sodium Ibuprofen on Postoperative Endodontic Pain

Primary Purpose

Irreversible Pulpitis

Status
Completed
Phase
Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
nurofen
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Irreversible Pulpitis

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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
  • Temporomandibular joint (TMJ) problems, bruxism, clenching or traumatic occlusion.
  • Inability to perceive the given instructions.

Sites / Locations

  • Cairo University

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Placebo Comparator

Arm Label

nurofen

placebo

Arm Description

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

starch tablet 30 minutes before treatment administered once (oral)

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

need for rescue medication
Amount of analgesics taken by the patient after root canal treatment

Full Information

First Posted
July 1, 2021
Last Updated
December 5, 2022
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT04964622
Brief Title
the Effect of Preoperative Sodium Ibuprofen on Postoperative Endodontic Pain
Official Title
Effect of Preoperative Single Dose of Sodium Ibuprofen Versus Placebo on Post-operative Pain for Patient With Symptomatic Irreversible Pulpitis Related to Mandibular Molar Teeth: Double Blind Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
December 1, 2021 (Actual)
Primary Completion Date
July 1, 2022 (Actual)
Study Completion Date
September 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed Description
Oral pharmacologic agents have been the primary option, and the use of drugs has increased exponentially. Many pharmacological agents have been used to manage endodontic pain, including Non-steroidal Anti-inflammatory Drugs (NSAIDs),.administration of NSAIDs before root canal treatment will reduce inflammatory process before it begins. NSAIDs are widely used to control post endodontic pain They act by blocking the activity of cyclooxygenase (COX 1 and 2) enzyme. In human dental pulps with irreversible pulpitis, a higher level of expression of COX 2.In cases of irreversible pulpitis NSAIDS can be administered preoperatively since they reduce the level of prostaglandinE2(PGE2) which is responsible for sensitization of nociceptors. Ibuprofen is one of the most commonly used NSAIDs and a potent inhibitor of prostaglandin (PG) synthesis that can manage various pain types and has anti-inflammatory activity. Enhancements in ibuprofen acid's pharmacokinetics have led to the development of ibuprofen salts with a faster dissolution rate and onset of action. These ibuprofen salts.Fast acting ibuprofen like Sodium ibuprofen delivers maximum plasma drug concentrations at about 30-40 min, compared with around 90-120 min for standard ibuprofen acid formulations

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irreversible Pulpitis

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Model Description
patient with symptomatic irriversible pulpitis
Masking
ParticipantCare Provider
Masking Description
drug will be put in sealed envelop and assistant supervisor will generate random sequence
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
nurofen
Arm Type
Other
Arm Description
sodium ibuprofen 1 tablet (256) 30 minutes before treatment administered once (oral)
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
starch tablet 30 minutes before treatment administered once (oral)
Intervention Type
Drug
Intervention Name(s)
nurofen
Other Intervention Name(s)
sodium ibuprofen
Intervention Description
tablet
Primary Outcome Measure Information:
Title
postoperative pain
Description
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)
Time Frame
Post-operative pain will be assessed immediately after treatment ,at 6 hours, at 12 hours, at 24 hours and 48 hours
Secondary Outcome Measure Information:
Title
need for rescue medication
Description
Amount of analgesics taken by the patient after root canal treatment
Time Frame
Amount of analgesics taken by the patient after root canal treatment, up to 48 hours postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: 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 Temporomandibular joint (TMJ) problems, bruxism, clenching or traumatic occlusion. Inability to perceive the given instructions.
Facility Information:
Facility Name
Cairo University
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27939729
Citation
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.
Results Reference
result
PubMed Identifier
32976660
Citation
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.
Results Reference
result

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the Effect of Preoperative Sodium Ibuprofen on Postoperative Endodontic Pain

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