Comparative Evaluation of Preoperative Methylprednisolone or Ibuprofen on Anesthetic Efficacy of Inferior Alveolar Nerve Blocks in Patients With Symptomatic Irreversible Pulpitis

The NPDS Endodontic clinic is a referral base clinic. All scheduled and/or emergency (sick-call) patients undergo a thorough clinical and radiographic examination. Patients will be asked to enroll in this prospective study when a diagnosis of symptomatic irreversible pulpitis is established, nonsurgical root canal treatment is indicated and they meet all study inclusion/exclusion criteria. An investigator, not involved in treatment, will explain the study and answer all question(s). Those that agree to participate will be consented and enrolled.

To qualify for this study, each patient had a tooth that fulfilled the criteria for a clinical diagnosis of symptomatic irreversible pulpitis: a vital mandibular posterior tooth actively experiencing pain; a prolonged response to cold testing using Green Endo-Ice (1,1,1,2 tetrafluoroethane; Hygenic Corp, Akron, OH) and had not taken any analgesics within the past 8 hours.

Exclusion criteria are as follows: any person under the age of 18 years; allergies or sensitivities to Ibuprofen or Methylprednisolone; allergies or sensitivities to local anesthetics or sulfites; were pregnant or nursing; medical condiditons that contraindicate the ingestion of Ibuprofen or Methylprednisolone, such as : active or latent peptic ulcers, Crohn's Disease, ulcerative colitis, gastroesophageal refulx, systemic fungal infections, active herpetic infections, asthma, open-angle glaucoma, osteoporosis or cirrohsis; has as a medical condition requiring the use of steroid medications; or had a history of a serious medical condition preventing routine dental treatment. Patients with no response to cold testing, presence of periradicular pathology (other than a widened periodontal ligament), or the lack of vital coronal pulpal tissue upon endodontic access were also excluded from the study. Thus, confirming the clinical diagnosis of irreversible pulpitis.

After written informed consent is obtained, a study subject will rate their pain prior to administration of an analgesic on a visual analogue scale (VAS) (14). The VAS used is 10 cm in length and divided into four categories. No pain defined at 0 mm, mild pain 1mm to 50mm, moderate pain 51mm to 74mm, and severe pain is defined as 75mm or greater. Subjects' will rate their pain on this scale at specific timeframes during treatment dependent upon when anesthetic success is achieved.

Two oral medications are compared in this study: 800mg Ibuprofen and 40mg Methylprednisolone. The medications are blinded to the subject and the provider. Each medication will be compounded, visibly identical and labeled as either A or B by the Investigational Pharmacy Department at WRNNMC (the PI will be provided the code in a sealed envelope). A third party, not involved in the study, will distribute the blinded medication to the provider for administration to the subject. Forty-five minutes after oral administration of the blinded medication, an inferior alveolar nerve block (IANB) and long buccal nerve block (LBNB) will be administered to each subject. Prior to the injection, the anesthetic injection site is dried with a 2 x 2 gauze, then 20% benzocaine topical anesthetic gel is placed at the site for 1 minute using a cotton tip applicator. Standard IANB and LBNB injections are administered with a 27-gauge, 1 ¼ in. needle attached to an aspirating syringe. Each cartridge of anesthetic used contains 34mg of 2% lidocaine with 0.017mg of epinephrine. Each subject receives 2 full cartridges of anesthetic in total with 1.5 cartridges given as an IANB and 0.5 cartridges given as a LBNB. Each cartridge was measured in millimeters from the end of the aluminum cap to the stopper. This distance was found to be 50mm in length, therefore at the 25mm mark on every cartridge a line was drawn dividing all the anesthetic solution into halves. All injections were administered by one of three board certified endodontic staff members.