Oral Dexamethasone for the Management of Symptomatic Irreversible Pulpitis Without Performing Pulpotomy

The Efficacy of Orally Administered Dexamethasone in the Management of Symptomatic Irreversible Pulpitis Without Performing Pulpotomy : : A Single-arm Open Clinical Trial

The efficacy of short course orally administered dexamethasone on the reduction of pain before conventional pulpotomy has not yet been demonstrated.

Therefore, the aim of this randomized clinical study is to assess the effect of dexamethasone on the reduction of pain in mandibular molars with irreversible pulpitis, without performing conventional pulpotomy in comparison to pain following pulpotomy.

Study Overview

• Status: Recruiting
• Conditions: Irreversible Pulpitis
• Intervention / Treatment: Drug: Dexamethasone Oral

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: L'emira Sara CHEHAB; Phone Number: +96176490949; Email: lemirasara.chehab@net.usj.edu.lb
• Study Contact Backup: Name: May Samaha Harfouche; Phone Number: 2211 9611421000; Email: may.samaha@usj.edu.lb

Study Locations

• Lebanon
  • Beirut, Lebanon
    • Recruiting
    • Saint Joseph University of Beirut
    • Contact: L'emira Sara CHEHAB; Phone Number: +96176490949; Email: lemirasara.chehab@net.usj.edu.lb

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Systemically healthy patients (Category: American Society of Anesthesiologists class 1) (ASA House of Delegates 2014) aged between 18 and 40 years with mandibular molars diagnosed with symptomatic irreversible pulpitis and a radiographically normal periapical region were included. Diagnosis was based on clinical and radiographic examination and pulp sensibility testing. Teeth were included if they responded long-term to cold test, the cold test was performed by injecting a syringe filled with cold water at the level of the suspicious tooth and the adjacent teeth. Teeth with deep occlusal decay, old restoration with underlying decay, recent restoration or crown were included. Patients that agreed to be contacted by phone after the emergency visit until pain relief, that were available to come back after the emergency visit for complete endodontic treatment and who had the ability to understand the informed consent form and pain recording scales used within this study were included.

Exclusion Criteria:

Teeth with acute or chronic apical abscess, pulp necrosis, septum syndrome and open apices were excluded. Medically compromised patients, pregnant and lactating women were excluded. Patients having history of allergy to local anesthetic solutions or any of the experimental drugs, on long-term medications that influenced pain threshold, analgesics, steroids and/or antibiotics in the recent past 24 h, were also excluded from the trial. Patients that suffered from a viral disease in evolution (Hepatitis, Herpes Zoster, Ocular Herpes), have or had a history of tuberculosis, hypertension, renal insufficiency, adrenocortical dysfunction, epilepsy, systemic fungal infections, GUILLAIN-BARRE syndrome, peptic ulcers and gastro intestinal disorders were excluded. Patients with Temporomandibular joint disorders were excluded. Patients suffering from mental disabilities were also excluded.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; Patients suffering from acute pain due to symptomatic irreversible pulpitis on a lower mandibular molar . Conventional emergency treatment is performed . Pulpotomy is performed after inferior alveolar nerve block injection ( IANB )
Experimental: Intervention Group; Patients suffering from acute pain due to symptomatic irreversible pulpitis on a lower mandibular molar . Short course orally administered dexamethasone after inferior alveolar nerve block injection without performing conventional pulpotomy	Drug: Dexamethasone Oral; For a patient suffering from an irreversible pulpitis on a lower mandibular molar , 4mg of dexamethasone are administered at baseline , after inferior alveolar nerve block injection and 4mg are administered 8 hours after the first dose at office

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain intensity	To measure the change of the intensity of pain on a visual analog scale at different time periods before and after the administration of dexamethasone in the intervention group and to measure pain before and after pulpotomy in the control group at different time periods	The pain was measured 4 times : 1- at baseline in the office on a visual analog scale , 2-8 hours after the first dose of dexa on a visual analog scale , 3- 12 hours after the first dose of dexa on a visual analog scale , 4- 24 hours afterthe first dose

Collaborators and Investigators

• Sponsor: May Samaha
• Investigators: Principal Investigator: L'emira Sara CHEHAB, Saint Joseph University of Beirut

Publications and helpful links

General Publications

• Mehrvarzfar P, Esnashari E, Salmanzadeh R, Fazlyab M, Fazlyab M. Effect of Dexamethasone Intraligamentary Injection on Post-Endodontic Pain in Patients with Symptomatic Irreversible Pulpitis: A Randomized Controlled Clinical Trial. Iran Endod J. 2016 Fall;11(4):261-266. doi: 10.22037/iej.2016.2.
• Pochapski MT, Santos FA, de Andrade ED, Sydney GB. Effect of pretreatment dexamethasone on postendodontic pain. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2009 Nov;108(5):790-5. doi: 10.1016/j.tripleo.2009.05.014. Epub 2009 Sep 12.
• Krasner P, Jackson E. Management of posttreatment endodontic pain with oral dexamethasone: a double-blind study. Oral Surg Oral Med Oral Pathol. 1986 Aug;62(2):187-90. doi: 10.1016/0030-4220(86)90044-7.
• Bidar M, Mortazavi S, Forghani M, Akhlaghi S. Comparison of Effect of Oral Premedication with Ibuprofen or Dexamethasone on Anesthetic Efficacy of Inferior Alveolar Nerve Block in Patients with Irreversible Pulpitis: A Prospective, Randomized, Controlled, Double-blind Study. Bull Tokyo Dent Coll. 2017;58(4):231-236. doi: 10.2209/tdcpublication.2016-0050.

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2023
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): June 1, 2023

Study Registration Dates

• First Submitted: February 15, 2023
• First Submitted That Met QC Criteria: March 6, 2023
• First Posted (Estimate): March 9, 2023

Study Record Updates

• Last Update Posted (Estimate): March 9, 2023
• Last Update Submitted That Met QC Criteria: March 6, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: "irreversible pulpitis " "mandibular molars " "pain" "pulpotomy" "dexamethasone"
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Dental Pulp Diseases; Pulpitis; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Dexamethasone
• Other Study ID Numbers: USJ-2022-212

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes