the Effect of Preoperative Sodium Ibuprofen on Postoperative Endodontic Pain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-01

Study Completion Date

2022-09-01

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Irreversible Pulpitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

patient with symptomatic irriversible pulpitis

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers

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

Study Groups

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nurofen

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

Group Type OTHER

nurofen

Intervention Type DRUG

tablet

placebo

starch tablet 30 minutes before treatment administered once (oral)

Group Type PLACEBO_COMPARATOR

nurofen

Intervention Type DRUG

tablet

Interventions

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nurofen

tablet

Intervention Type DRUG

Other Intervention Names

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sodium ibuprofen

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes