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

NCT05761730 | Unknown Phase 1 FDA Drug

• 1 other identifier: USJ-2022-212
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Irreversible Pulpitis

Keywords

"irreversible pulpitis " "mandibular molars " "pain" "pulpotomy" "dexamethasone"

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Control group

NO INTERVENTION

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 )

Intervention Group

EXPERIMENTAL

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

Interventions

Dexamethasone Oral DRUG

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

Intervention Group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• May Samaha: lead

Study Sites (1)

Saint Joseph University of Beirut

Beirut, Lebanon

RECRUITING

Related Publications (4)

• 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.

  PMID: 19748294 BACKGROUND

• 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.

  PMID: 27790253 BACKGROUND

• 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.

  PMID: 3528979 BACKGROUND

• 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.

  PMID: 29269717 BACKGROUND

MeSH Terms

Interventions

Dexamethasone

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• L'emira Sara CHEHAB

  saint joseph university of beirut

  PRINCIPAL INVESTIGATOR

Central Study Contacts

L'emira Sara CHEHAB

CONTACT

+96176490949; lemirasara.chehab@net.usj.edu.lb

May Samaha Harfouche

CONTACT

9611421000; may.samaha@usj.edu.lb

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of the medical library- Saint Joseph University

Model Details: The participants will be allocated to two groups randomly 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 ( intervention group ) in comparison to pain following pulpotomy ( control group )

Study Record Dates

• First Submitted: February 15, 2023
• First Posted: March 9, 2023
• Study Start: February 15, 2023
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: March 9, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

LE (1)