Clinical trial NCT03341260: Effect of Preoperative Diclofenac Potassium on Postoperative Endodontic Pain
Official title: Effect of Preoperative, Single-dose Diclofenac Potassium on Postoperative Endodontic Pain in Patients With Symptomatic Irreversible Pulpitis: A Double Blind Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Pulpitis - Irreversible
Keywords: Pulpitis, irreversible Pulpitis,
Diclofenac Potassium
Premedication, Preoperative Analgesic
Postoperative pain
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-11-14
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The patients will be randomly divided into 2 groups:

Experimental group:

50 mg Diclofenac Potassium to be administered one hour before treatment.

Control group:

Placebo to be administered one hour before treatment.
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to assess the effect of preoperative a single-dose of 50 mg diclofenac potassium on postoperative endodontic pain in mandibular molars with symptomatic irreversible pulpitis.

Detailed description: Patients with moderate-to-severe preoperative pain are selected. Patients receive either a single-dose of 50 mg diclofenac potassium (group A) or a placebo tablet as a control (group B). All patients receive the assigned premedication one hour before single-visit root canal treatment. Postoperative endodontic pain is measured at the following time points: 6 , 12,24,48 h after treatment. The incidence of analgesic intake is also recorded.

Eligibility criteria: Inclusion Criteria:

* Patients with active pain (moderate-to-severe) in mandibular molars.
* Patients with prolonged response to cold testing and electric pulp tester.
* Patient with the ability to understand and use pain scales.
* Patient with vital coronal pulp tissue on access.
* Patient who accept to enroll to the study.

Exclusion Criteria:

* Patients' allergies or any other contraindication to diclofenac potassium or articaine.
* Pregnant and lactating females.
* Patients having pain medication in the last 6 hours.
* 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 active peptic ulcer and gastrointestinal disorders.
* Patients with history of bleeding problems or anticoagulant use within the last month.

Primary outcomes:
measure: Postoperative endodontic pain
timeFrame: Up to 2 days after endodontic treatment
Secondary outcomes:
measure: Analgesic intake
timeFrame: Up to 2 days after endodontic treatment
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Dentistry Faculty
Study officials:
affiliation: Faculty of Oral and Dental Medicine/ Cairo University.
name: Amatallah H Al-Rawhani, Pos
role: PRINCIPAL_INVESTIGATOR
References:
citation: Elzaki WM, Abubakr NH, Ziada HM, Ibrahim YE. Double-blind Randomized Placebo-controlled Clinical Trial of Efficiency of Nonsteroidal Anti-inflammatory Drugs in the Control of Post-endodontic Pain. J Endod. 2016 Jun;42(6):835-42. doi: 10.1016/j.joen.2016.02.014. Epub 2016 Apr 12.
citation: Metri M, Hegde S, Bhandi S. Effect of pretreatment diclofenac sodium on postendodontic pain: A randomised controlled trial. J Conserv Dent. 2016 Jan-Feb;19(1):7-10. doi: 10.4103/0972-0707.173183.