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

NCT04481971 | Unknown Phase 2

• 1 other identifier: E-20-4818
• Study Type: interventional
• Target: 72
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Endodontics; Pain

Outcome Measures

Primary Outcomes (1)

• Change in post-operative pain

  Questionnaire (visual analogue scale)

  Change from baseline pain and pain at 4, 12, 24, and 48 hours after initiation of therapy

Study Arms (3)

40 mg

EXPERIMENTAL

Drug: Prednisolone

20 mg

EXPERIMENTAL

Drug: Prednisolone

Placebo

PLACEBO COMPARATOR

Drug: lactose in capsules gelatin

Interventions

Prednisolone DRUG

Tablets

20 mg; 40 mg

lactose in capsules gelatin DRUG

Tablets

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• King Saud University: lead

MeSH Terms

Conditions

Pain

Interventions

Prednisolone; Lactose

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 12, 2020
• First Posted: July 22, 2020
• Study Start: August 9, 2020
• Primary Completion: November 1, 2020
• Study Completion: December 31, 2020
• Last Updated: July 22, 2020

Record last verified: 2020-07