A Comparison of Two Different Single Doses of Prednisolone on Endodontic Inter-appointment Pain
Status:
Not yet recruiting
Trial end date:
2020-12-31
Target enrollment:
Participant gender:
Summary
The purpose of this prospective randomized, double-blind, placebo-controlled study is to
compare the efficiency of 2 different single doses of pre-operative oral prednisolone (20 &
40 mg) for the control of inter-appointment endodontic pain in patients diagnosed with
symptomatic irreversible pulpitis. The tested null hypothesis is that there is no difference
in pain relief between the two doses.
Seventy-two patients presented for treatment at Dental University Hospital will be selected.
The inclusion criteria are systemically healthy patients (ASA classification I or II), with
no contraindications to corticosteroids (osteoporosis, systemic fungal infections, poorly
controlled insulin-dependent diabetes mellitus, ocular herpes simplex, primary glaucoma,
allergy to corticosteroids, ulcerative colitis, a compromised immune status, and major
psychosis). Patients under 18 years, pregnant or breast-feeding, took an analgesic agent
within the last 6 hours, those with un-restorable teeth, teeth with periodontal disease will
be excluded. Patients having mandibular molars with symptomatic irreversible pulpitis with
normal periapical area and moderate-severe preoperative pain (i.e. ≥ 34 mm on a visual analog
scale (VAS)) will be included.
Subjects will be randomly divided into 3 groups, namely placebo (control), 20 mg prednisolone
and 40 mg prednisolone according to a computerized random numbers. Each participant will
receive a single oral dose of either formulation (drug or placebo) 30 minutes before starting
endodontic treatment. All medications will be placed in identical containers and will be
coded; thus, both the operator and the patients will be blinded to the type of medication.
Endodontic treatment will be performed and canals will be instrumented to a minimum of size
30, .04 taper following the standardized protocol. Postoperative pain will be assessed by
using a visual analogue scale at 4, 12, 24 and 48 hours after initiation of therapy.