Pulpitis - Irreversible
Conditions
Keywords
Pulpitis, irreversible Pulpitis,, Diclofenac Potassium, Premedication, Preoperative Analgesic, Postoperative pain
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.
Interventions
DRUGDiclofenac Potassium 50mg Tab.
A 50 mg tablet of the medication to be taken one hour before initiation of endodontic treatment.
DRUGPlacebo
A placebo will be taken one hour before initiation of endodontic treatment.
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative endodontic pain | Up to 2 days after endodontic treatment | Pain after completion root canal treatment measured by Heft-parker visual analogue scale. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Analgesic intake | Up to 2 days after endodontic treatment | The incidence of analgesic intake is recorded |
Countries
Egypt
Outcome results
None listed