Comparative Evaluation of the Effectiveness of Premedication With Two Different Single Doses of Prednisolone on Inter-appointment Pain in Symptomatic Patients With Irreversible Pulpitis: a Double-blind Randomized Controlled Clinical Trial
| Registry | NCT04481971 |
|---|---|
| Status | Unknown |
| Phase | Phase 2 |
| Study type | Interventional; randomized, parallel, masking: double, treatment |
| Enrollment | 72 (Estimated) |
| Sponsor | King Saud University (Other) |
| Conditions | Endodontics, Pain |
| Interventions | Prednisolone, lactose in capsules gelatin (Drug) |
| Dates | start 2020-08-09 (estimated), primary completion 2020-11-01 (estimated), completion 2020-12-31 (estimated), first posted 2020-07-22, last updated 2020-07-22 |
Related Papers Related Patents Related Grants Related Experts
All trials for Endodontics All trials for Pain All trials of Prednisolone All trials of lactose in capsules gelatin
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| 40 mg | Experimental | Drug: Prednisolone | |
| 20 mg | Experimental | Drug: Prednisolone | |
| Placebo | Placebo comparator | Drug: lactose in capsules gelatin |
Sex: All, ages: 18 Years to 45 Years, accepts healthy volunteers
Inclusion Criteria: * 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). Exclusion Criteria: * 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