Effect of Ibuprofen Sustained Release on Intraoperative and Postoperative Pain in Mandibular Molars

Study Overview
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Brief Summary
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The study is conducted to evaluate the effect of Ibuprofen sustained release premedication on the success of buccal infiltration anaesthesia, intaroperative pain and post operative pain in mandibular molars with symptomatic irreversible pulpitis and apical periodontitis

Official Title
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The Effect of Ibuprofen Sustained Release Oral Premedication on Intraoperative and Postoperative Pain After Single-visit Root Canal Treatment of Mandibular Molars With Symptomatic Irreversible Pulpitis and Apical Periodontitis

Conditions
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Anesthesia

Intervention / Treatment
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* Drug: Brufen Retard


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Systemically healthy patients (ASA I or II). Patients with Mandibular molar teeth diagnosed with: Pre-operative sharp pain marked on VAS scale by reading not less than 6. Vital exaggerated response of pulp tissue to cold pulp tester (ethyl chloride spray) and electric pulp tester. Normal periapical radiographic appearance or slight widening in lamina dura. Positive response and pain provoked by percussion. Exclusion Criteria: Allergy to Ibuprofen 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. Pregnant or nursing females. Teeth that have: Periodontal affection (with pocket depth greater than 5mm, associated with swelling or fistulous tract, or greater than grade I mobility) No possible restorability.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ibuprofen sustained release<br>Single dose of 800 mg Brufen Retard oral premedication will be administered 1 hour before local anesthesia | Drug: Brufen Retard<br>* 800 mg tablet of Brufen Retard will be adminstered orally one hour before local anesthesia<br>|
| Placebo Comparator: Placebo<br>1 capsule of 500 mg of glucose oral premedication will be adminstered 1 hour before local anesthesia | Drug: Brufen Retard<br>* 800 mg tablet of Brufen Retard will be adminstered orally one hour before local anesthesia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of buccal infiltration anaesthesia measured using Visual analogue scale | intensity of pain during root canal treatment procedures is recorded by the patient using VAS where 0=no pain, 1-3=mild pain, 4-6=moderate pain and 7-10=severe pain | During root canal treatment procedures | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intensity of intraoperative pain | intensity of pain during root canal treatment procedures is recorded by the patient using VAS where 0=no pain, 1-3=mild pain, 4-6=moderate pain and 7-10=severe pain | During root canal treatment procedures | 
| Postoperative pain | Intensity of pain felt after endodontic treatment recorded by the patient using VAS where 0=no pain, 1-3=mild pain, 4-6=moderate pain and 7-10=severe pain | up to 48 hours after endodontic treatment | 
| Number of needed analgesic tablets in case of intolerable pain | The patient will record the number of analgesic tablets taken in case of intolerable pain | up to 48 hours after endodontic treatment |