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

Study Overview
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Brief Summary
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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.

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

Conditions
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Irreversible Pulpitis

Intervention / Treatment
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* Drug: Dexamethasone Oral


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>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<br>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<br>* 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<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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irreversible pulpitis  mandibular molars  pain pulpotomy dexamethasone