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

Cairo University (CU)

Status: Unknown

Conditions: Anesthesia

Treatments: Drug: Brufen Retard

Study type: Interventional

Funder types: Other

Identifiers

NCT05053009

ENDO3-7-1

Details and patient eligibility

About

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

Enrollment: 48 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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48 participants in 2 patient groups, including a placebo group

Ibuprofen sustained release

Experimental group

Description:

Single dose of 800 mg Brufen Retard oral premedication will be administered 1 hour before local anesthesia

Treatment:

Drug: Brufen Retard

Placebo

Placebo Comparator group

Description:

1 capsule of 500 mg of glucose oral premedication will be adminstered 1 hour before local anesthesia

Treatment:

Drug: Brufen Retard