The Effect of Three Different Medications on Anesthetic Success and Postoperative Pain

Cairo University124 enrolled

Overview

Pain is a very important factor in Endodontic treatment, Both intra- and Post-operatively. In case of symptomatic Irreversible pulpitis, a build up of inflammatory mediators makes it very difficult for the operator to reach the desired level of anesthesia in order to deliver a pain free treatment as well as to eliminate or at least reduce post-operative pain incidence and severity. therefore, a number of pre- medications was suggested with variable success rates. Therefore this trial aims at the use of a new category of anti-inflammatory medications which would be less harmful than the standard NSAIDs or steroids.

Background and Rationale For patients with irreversible pulpitis, achieving adequate pulpal anesthesia during endodontic therapy is a major concern, posing a considerable difficulty from a clinical point of view as an inadequately anesthetized hot tooth with severe pain will not only elevate the patients' apprehension but will also stress the practicing clinician. Inferior alveolar nerve block (IANB) technique is commonly used to achieve pulpal anesthesia in mandibular teeth. The failure rates of a single IANB block injection of local anesthetic in patients with irreversible pulpitis range between 30 and 90 %. Several clinical studies identified inflammation as a major cause of failure of local anesthesia and an important component of the pathogenesis of hyperalgesia. The use of both steroidal and nonsteroidal anti-inflammatory drugs (NSAIDs) was investigated to improve the success rates of IANB anesthesia. Combined with the bioflavonoid rutin (Rutoside), the proteases Trypsin and Bromelain have been extensively investigated as alternatives to conventional therapies for pain and swelling associated with diverse conditions. The aim of the trial To assess the effect of Trypsin, Bromelain and Rutoside combination versus diclofenac potassium or prednisolone or placebo on the anesthetic success of IANB and postoperative pain in patients with symptomatic irreversible pulpitis. The null hypothesis tested is " In patients with symptomatic irreversible pulpitis in their mandibular molars, there is no difference between Trypsin, Bromelain and Rutoside combination or diclofenac potassium or prednisolone or placebo on anesthetic success and post-operative pain after endodontic treatment."

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Interventions

Trypsin, Bromelain and RutosideDRUG

Flamogen is a combination of trypsin 48 mgs, bromelain 90mg and rutoside 100 mg in one tablet that provides an anti inflammatory, anti edematous activity. each patient will receive a single dose of 2 tablets one hour before treatment.

Diclofenac Potassium 50mg TabDRUG

Non-steroidal anti inflammatory drug. Cataflam is known for its potent anti inflammatory and analgesic properties. each patient will receive one tablet of Cataflam 50 mg 1 hour before treatment.

Prednisolone Oral TabletDRUG

Steroids are potent anti inflammatory drugs, patients are going to receive one tablet of 20 mg solupred one hour before treatment

PlaceboOTHER

An opaque white capsule filled with starch

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with symptomatic irreversible pulpitis. * Patients with active pain (moderate-to-severe) in mandibular molars. * Males and females. * Patient with the ability to understand and use pain scales. * Patient who accepts to enroll to the study Exclusion Criteria: * Patients' allergies or any other contraindication to any of the used medications or mepivacaine. * Pregnant and lactating females. * Patients have been taking pain medication 12 hours earlier. * Patient has more than one symptomatic mandibular tooth in the same quadrant. * Patients with periradicular pathosis and/or radiolucency other than widened periodontal ligaments. * Patients with contributory medical history (ASA\>II).

Outcomes

Primary Outcomes

Success of Anesthesia

Success of Inferior alveolar Nerve block anesthesia will be measured by recording the patient's pain severity before and after anesthesia administration as well as during endodontic procedures. each patient will record his/her pain on a "Numerical Rating Scale" (NRS), the NRS is an eleven point scale anchored at both ends by zero representing no pain and 10 representing pain as bad as it could be.

Time frame: Perioperative

Post-operative pain

postoperative pain as recorded by the patient after completion of treatment in on visit. patient will receive a pain diary to record their postoperative pain incidence and severity at 6, 12, 24, 72 hours and 7 days after endodontic treatment. Each patient will record his/her pain on a "Numerical Rating Scale" (NRS), the NRS is an eleven point scale anchored at both ends by zero representing no pain and 10 representing pain as bad as it could be.

Time frame: Each patient will deliver his/her pain diary one week after root canal treatment