the Effect of Preoperative Sodium Ibuprofen on Postoperative Endodontic Pain

Irreversible Pulpitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04964622
• Other study ID #: postoperative endodontic pain
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: December 1, 2021
• Est. completion date: September 1, 2022

Study information

• Verified date: December 2022
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 1, 2022
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Irreversible Pulpitis
• Pulpitis

Intervention

Drug:
• nurofen
tablet

Locations

Country	Name	City	State
Egypt	Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & 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. do — View 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 treatm — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	need for rescue medication	Amount of analgesics taken by the patient after root canal treatment	Amount of analgesics taken by the patient after root canal treatment, up to 48 hours postoperatively