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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-30

Study Completion Date

2022-10-31

Brief Summary

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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

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Detailed Description

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Conditions

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Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel assignment

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Triple

Study Groups

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Ibuprofen sustained release

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

Group Type EXPERIMENTAL

Brufen Retard

Intervention Type DRUG

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

Placebo

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

Group Type PLACEBO_COMPARATOR

Brufen Retard

Intervention Type DRUG

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

Interventions

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Brufen Retard

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes