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the Effect of Preoperative Sodium Ibuprofen on Postoperative Endodontic Pain

Cairo University (CU) logo

Cairo University (CU)

Status and phase

Completed
Phase 2
Phase 1

Conditions

Irreversible Pulpitis

Treatments

Drug: nurofen

Study type

Interventional

Funder types

Other

Identifiers

NCT04964622
postoperative endodontic pain

Details and patient eligibility

About

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.

Full 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

Enrollment

50 patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts 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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

50 participants in 2 patient groups, including a placebo group

nurofen
Other group
Description:
sodium ibuprofen 1 tablet (256) 30 minutes before treatment administered once (oral)
Treatment:
Drug: nurofen
placebo
Placebo Comparator group
Description:
starch tablet 30 minutes before treatment administered once (oral)
Treatment:
Drug: nurofen

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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