The Effect of Different Intra-canal Medications on Postoperative Pain

• Trial design:

• A Randomized controlled, double-blind, parallel-arm, clinical trial.
• Allocation ratio 1:1:1
• Framework: superiority
• Study settings:

Outpatient clinic of Endodontics at the Faculty of Dentistry, Egyptian Russian University, Badr city, Cairo governorate, Egypt.

• Eligibility criteria

• Inclusion criteria:

• Patients with necrotic pulps.
• Adult, healthy patients, older than 18 years old
• Males and females.
• Patient with the ability to understand and use pain scales.
• Patient who accepts enroll to the study.
• Exclusion criteria:

• Patients' allergies or any other contraindication to any of the medications used.
• Pregnant and lactating females.
• Patients have been taking pain medication 12 hours earlier.
• Patients who have more than one symptomatic mandibular tooth in the same quadrant.
• Patients with contributory medical history (ASA>II).
• Diagnosis:

The diagnosis of pulp necrosis is confirmed through the patients' history, lack of response to cold testing and negative response to electric pulp tester whenever .The treatment will be done on two- visits.

• Treatment procedure: Each patient will be given an NRS chart to rate her /his presenting pain as preoperative pain. After complete mechanical preparation, each patient will be randomly assigned to either of three groups as follows, group 1: ibuprofen will be used as an intracanal medication, group 2: nitrofurantoin will be used as an intra canal medication and group 3: CaOH will be used as an intracanal medicament. The access cavity will be then sealed with temporary filling (MD-TEMP, META BIOMED CO., LTD. Chungbuuk, Korea). Post-operative instructions and appropriate post-operative rescue medication will be prescribed (400mg Ibuprofen). All patients will be asked to record their postoperative pain level felt on NRS at 6, 12, 24, 48, 72 hours and 7 days.

One week after the first visit, patients will be recalled to the clinic to complete their root canal treatment as recommended. All canals will be dried then obturated by the modified single cone technique using 0.04 taper gutta percha points and epoxy resin sealer. Patients will be referred to an operative or a fixed prosthodontics specialist for crown placement at the Faculty of Dentistry, Egyptian Russian University.

Research objective (state the aim) The aim of this study is to assess the effect of ibuprofen, nitrofurantoin and calcium hydroxide on postoperative pain after endodontic treatment of necrotic mandibular posterior teeth.

Sample size: (if calculation equation is used please state) A total of 111 patients, 37 per group needed for the clinical trial was calculated

Grouping & Randomization used:(specify if present) Three groups Group 1: ibuprofen Group 2: nitrofurantoin Group 3: calcium hydroxide

Outcome variables:

The primary outcome the effect of ibuprofen, nitrofurantoin and calcium hydroxide on postoperative pain after endodontic treatment of necrotic mandibular posterior teeth.

Postoperative pain will be measured using NRS at 6, 12, 24, 48, 72 hours postoperatively. Numerical Rating Scale (NRS) (20): It is an 11-point scale consisting of numbers from 0 through 10; - 0 reading represents "no pain" - 1-3 readings represent "mild pain" - 4- 6 readings represent "moderate pain" - 7- 10 readings represent "severe pain"

Inclusion criteria

• Patients with necrotic pulps.
• Adult, healthy patients, older than 18 years old
• Males and females.
• Patient with the ability to understand and use pain scales.
• Patient who accepts enroll to the study.

Exclusion criteria

• Patients' allergies or any other contraindication to any of the medications used.
• Pregnant and lactating females.
• Patients have been taking pain medication 12 hours earlier.
• Patients who have more than one symptomatic mandibular tooth in the same quadrant.
• Patients with contributory medical history (ASA>II).