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Clinical Trials/NCT05053009
NCT05053009
Unknown
Not Applicable

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

Cairo University0 sites48 target enrollmentNovember 2021
ConditionsAnesthesia
InterventionsBrufen Retard

Overview

Phase
Not Applicable
Intervention
Brufen Retard
Conditions
Anesthesia
Sponsor
Cairo University
Enrollment
48
Primary Endpoint
Efficacy of buccal infiltration anaesthesia measured using Visual analogue scale
Last Updated
4 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
November 2021
End Date
October 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mariam Ahmed Hossam

Resident at faculty of dentistry, Cairo University

Cairo University

Eligibility Criteria

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
  • 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.

Arms & Interventions

Ibuprofen sustained release

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

Intervention: Brufen Retard

Placebo

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

Intervention: Brufen Retard

Outcomes

Primary Outcomes

Efficacy of buccal infiltration anaesthesia measured using Visual analogue scale

Time Frame: 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 Outcomes

  • Intensity of intraoperative pain(During root canal treatment procedures)
  • Number of needed analgesic tablets in case of intolerable pain(up to 48 hours after endodontic treatment)
  • Postoperative pain(up to 48 hours after endodontic treatment)

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