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

NCT ID: NCT05761730

Last Updated: 2023-03-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-15
• Study Completion Date: 2023-06-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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 )

Group Type: NO_INTERVENTION

No interventions assigned to this group

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

Group Type: EXPERIMENTAL

Dexamethasone Oral

Intervention Type: 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

Interventions

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

May Samaha

OTHER

Sponsor Role: lead

Responsible Party

May Samaha

Director of the medical library- Saint Joseph University

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

L'emira Sara CHEHAB

Role: PRINCIPAL_INVESTIGATOR

saint joseph university of beirut

Locations

Saint Joseph University of Beirut

Beirut, , Lebanon

Site Status: RECRUITING

Countries

Lebanon

Central Contacts

L'emira Sara CHEHAB

Role: CONTACT

lemirasara.chehab@net.usj.edu.lb

+96176490949

May Samaha Harfouche

Role: CONTACT

may.samaha@usj.edu.lb

9611421000 ext. 2211

Facility Contacts

L'emira Sara CHEHAB

Role: primary

lemirasara.chehab@net.usj.edu.lb

+96176490949

References

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.

Reference Type: BACKGROUND

PMID: 19748294 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27790253 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 3528979 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29269717 (View on PubMed)

Other Identifiers

USJ-2022-212

Identifier Type: -

Identifier Source: org_study_id