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

Primary Purpose

Irreversible Pulpitis

Status
Recruiting
Phase
Phase 1
Locations
Lebanon
Study Type
Interventional
Intervention
Dexamethasone Oral
Sponsored by
May Samaha
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irreversible Pulpitis focused on measuring "irreversible pulpitis " "mandibular molars " "pain" "pulpotomy" "dexamethasone"

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Saint Joseph University of BeirutRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control group

Intervention Group

Arm Description

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 )

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
February 15, 2023
Last Updated
March 6, 2023
Sponsor
May Samaha
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1. Study Identification

Unique Protocol Identification Number
NCT05761730
Brief Title
Oral Dexamethasone for the Management of Symptomatic Irreversible Pulpitis Without Performing Pulpotomy
Official Title
The Efficacy of Orally Administered Dexamethasone in the Management of Symptomatic Irreversible Pulpitis Without Performing Pulpotomy : : A Single-arm Open Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 15, 2023 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
May Samaha

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irreversible Pulpitis
Keywords
"irreversible pulpitis " "mandibular molars " "pain" "pulpotomy" "dexamethasone"

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
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 )
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm Description
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 )
Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Dexamethasone Oral
Intervention Description
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
Primary Outcome Measure Information:
Title
Pain intensity
Description
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
Time Frame
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
L'emira Sara CHEHAB
Phone
+96176490949
Email
lemirasara.chehab@net.usj.edu.lb
First Name & Middle Initial & Last Name or Official Title & Degree
May Samaha Harfouche
Phone
9611421000
Ext
2211
Email
may.samaha@usj.edu.lb
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
L'emira Sara CHEHAB
Organizational Affiliation
saint joseph university of beirut
Official's Role
Principal Investigator
Facility Information:
Facility Name
Saint Joseph University of Beirut
City
Beirut
Country
Lebanon
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
L'emira Sara CHEHAB
Phone
+96176490949
Email
lemirasara.chehab@net.usj.edu.lb

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
19748294
Citation
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.
Results Reference
background
PubMed Identifier
27790253
Citation
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.
Results Reference
background
PubMed Identifier
3528979
Citation
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.
Results Reference
background
PubMed Identifier
29269717
Citation
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.
Results Reference
background

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

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