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the Effect of Preoperative Sodium Ibuprofen on Postoperative Endodontic Pain

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

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04964622
Enrollment
50
Registered
2021-07-16
Start date
2021-12-01
Completion date
2022-09-01
Last updated
2022-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Irreversible Pulpitis

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

Interventions

DRUGnurofen

tablet

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)

Masking description

drug will be put in sealed envelop and assistant supervisor will generate random sequence

Intervention model description

patient with symptomatic irriversible pulpitis

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
postoperative painPost-operative pain will be assessed immediately after treatment ,at 6 hours, at 12 hours, at 24 hours and 48 hourspain 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

MeasureTime frameDescription
need for rescue medicationAmount of analgesics taken by the patient after root canal treatment, up to 48 hours postoperativelyAmount of analgesics taken by the patient after root canal treatment

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026