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

Cairo University48 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Anesthesia

Interventions

Brufen RetardDRUG

800 mg tablet of Brufen Retard will be adminstered orally one hour before local anesthesia

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Systemically healthy patients (ASA I or II). 2. 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: 1. Allergy to Ibuprofen 2. Medically compromised patients having significant systemic disorders. (ASA III or IV). 3. History of intolerance to NSAIDS. 4. Patients with two or more adjacent teeth requiring endodontic treatment. 5. Pregnant or nursing females. 6. 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.

Outcomes

Primary Outcomes

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

Time frame: During root canal treatment procedures

Secondary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: up to 48 hours after endodontic treatment

Central Contacts

Mariam Ah Hossam, B.D.S

CONTACT

01110913251 mariam.ahmed.hosam@dentistry.cu.edu.eg

Data from ClinicalTrials.gov

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