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

Not Applicable

• Conditions: Anesthesia
• Interventions: Drug: Brufen Retard

• Registration Number: NCT05053009
• Lead Sponsor: Cairo University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-09
• Study First Submitted: 2021-09-11
• Study First Submitted QC: 2021-09-21
• Last Update Submitted: 2021-09-21
• Study First Posted: 2021-09-22
• Last Update Posted: 2021-09-22
• Study Start: 2021-11
• Primary Completion: 2022-10
• Study Completion: 2022-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 48

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ibuprofen sustained release	Brufen Retard	Single dose of 800 mg Brufen Retard oral premedication will be administered 1 hour before local anesthesia
Placebo	Brufen Retard	1 capsule of 500 mg of glucose oral premedication will be adminstered 1 hour before local anesthesia

Primary Outcome Measures

Name	Time	Method
Efficacy of buccal infiltration anaesthesia measured using Visual analogue scale	During root canal treatment procedures	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

Secondary Outcome Measures

Name	Time	Method
Intensity of intraoperative pain	During root canal treatment procedures	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
Number of needed analgesic tablets in case of intolerable pain	up to 48 hours after endodontic treatment	The patient will record the number of analgesic tablets taken in case of intolerable pain
Postoperative pain	up to 48 hours after endodontic treatment	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