Effect of Diclofenac Potassium Versus Prednisolone on Post-endodontic Pain and Pulpal IL-8 Expression

NCT04608981 | Unknown Phase 4

• 1 other identifier: CairoU_IL8
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

Brief Summary

To assess the effect of using diclofenac potassium versus prednisolone as a pre-medication compared to placebo on:

• Intensity of post-endodontic pain in patients with symptomatic irreversible pulpitis.
• Pulpal IL-8 expression.
• Incidence of post-endodontic pain in patients with symptomatic irreversible pulpitis.

Conditions

Symptomatic Irreversible Pulpitis

Keywords

prednisolone; diclofenac potassium; interleukin-8

Outcome Measures

Primary Outcomes (1)

• Change in the intensity of post-endodontic pain

  Pain intensity will be evaluated using visual analogue scale

  Immediately after treatment completion; and at 6, 12, 24, and 48 hours post-operatively

Secondary Outcomes (1)

• Quantification of pulpal IL-8

  During the procedure

Other Outcomes (1)

• Change in the incidence of post-endodontic pain

  Immediately after treatment completion; and at 6, 12, 24, and 48 hours post-operatively

Study Arms (3)

Prednisolone premedication

EXPERIMENTAL

Single, oral dose of 30 mg prednisolone pre-medication 30 min before starting endodontic treatment.

Drug: Prednisolone 30 mg

Diclofenac potassium premedication

EXPERIMENTAL

Single, oral dose of 50 mg diclofenac potassium pre-medication 1 hour before starting endodontic treatment.

Drug: Diclofenac Potassium 50mg Tab

Placebo

PLACEBO COMPARATOR

Placebo tablet 1 hour before starting endodontic treatment.

Drug: Placebo

Interventions

Prednisolone 30 mg DRUG

Steroidal anti-inflammatory drug as a preoperative medication

Also known as: One and a half tablets Solupred oro 20 mg, ARE, Aventis Intercontinental, Paris, France

Prednisolone premedication

Diclofenac Potassium 50mg Tab DRUG

Non-steroidal anti-inflammatory drug as a preoperative medication

Also known as: Cataflam; NOVARTIS Pharma, Basel, Switzerland

Diclofenac potassium premedication

Placebo DRUG

Starch

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age between 18-50 years.
• Males and females.
• American Society of Anesthesiologists class 1 or 2.
• Mandibular premolar teeth with:
• Endodontic pulpal diagnosis of symptomatic irreversible pulpitis
• Normal/slight widening in the periodontal membrane space (PMS).
• Patients who had not taken any anti-inflammatory drugs the day of the root canal procedure unless they belong to one of the intervention groups.
• Patients who accept to participate in the trial, understand the VAS, and can sign the informed consent

You may not qualify if:

• Cases with acute peri-apical conditions (acute apical periodontitis/ acute apical abscess), pulpal necrosis, previously initiated therapy, or previously treated.
• Teeth other than single-rooted teeth.
• Radiographic evidence of external or internal root resorption vertical root fracture, perforation, or calcification.
• Immature teeth.
• Unrestorable teeth or teeth with severe periodontal disease.
• Patients with a known allergy, sensitivity, or history of other adverse reactions to the medications administered.
• Patients with a history of active peptic ulcer within the preceding 12 months, bleeding problems, anticoagulant use within the last month, or kidney disease.
• Patients who took analgesics/ anti-inflammatory drugs (steroidal or non-steroidal) the day of endodontic treatment.
• Pregnant or nursing females.
• Patients who are unable to provide informed consent

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Interventions

Prednisolone; Diclofenac

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Ahmed A Soliman, MSc

  Cairo University

  PRINCIPAL INVESTIGATOR

• Khaled Ezzat, PhD

  Cairo University

  STUDY DIRECTOR

• Sara S Abouelenien, PhD

  Cairo University

  STUDY CHAIR

Central Study Contacts

Ahmed A Soliman, MSc

CONTACT

+201006779533; aasoliman89@gmail.com

Sara S Abouelenien, PhD

CONTACT

+201000703203

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: In this proposed study, the participant, and the assessor will be blinded. The participants will be blinded to the study hypothesis as to which intervention is expected to be better. The patients, who already do not know their treatment group, will assess the level of their post-endodontic pain. * The laboratory technician at the microbiological department will not know the treatment group of the patients. * The treatment groups will remain anonymous at the end of the study during assessment by the statistician.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 13, 2020
• First Posted: October 30, 2020
• Study Start: March 1, 2021
• Primary Completion: December 1, 2021
• Study Completion: February 1, 2022
• Last Updated: October 30, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share