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

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

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 Overview

• Status: Not yet recruiting
• Conditions: Anesthesia
• Intervention / Treatment: Drug: Brufen Retard

• Study Type: Interventional
• Enrollment (Anticipated): 48
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mariam Ah Hossam, B.D.S; Phone Number: 002 01110913251; Email: mariam.ahmed.hosam@dentistry.cu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2021
• Primary Completion (Anticipated): October 1, 2022
• Study Completion (Anticipated): October 1, 2022

Study Registration Dates

• First Submitted: September 11, 2021
• First Submitted That Met QC Criteria: September 21, 2021
• First Posted (Actual): September 22, 2021

Study Record Updates

• Last Update Posted (Actual): September 22, 2021
• Last Update Submitted That Met QC Criteria: September 21, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Ibuprofen
• Other Study ID Numbers: ENDO3-7-1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No