Pain Clinical Trial - A Comparison of Two Different Single Doses of

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04481971
Study type	Interventional
Source	King Saud University
Contact
Status	Not yet recruiting
Phase	Phase 2
Start date	August 9, 2020
Completion date	December 31, 2020

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

A Comparison of Two Different Single Doses of Prednisolone on Endodontic Inter-appointment Pain

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms