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Effect of Pretreatment Dexamethazone on Pain and Success of Nerve Block

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ClinicalTrials.gov Identifier: NCT03199482
Recruitment Status : Unknown
Verified June 2017 by Mai Mohamed Safei Eldin Sayed, Cairo University.
Recruitment status was:  Not yet recruiting
First Posted : June 27, 2017
Last Update Posted : June 27, 2017
Sponsor:
Information provided by (Responsible Party):
Mai Mohamed Safei Eldin Sayed, Cairo University

Brief Summary:
A Comparative Evaluation of the effect of pretreatment dexamethasone versus placebo on post-endodontic pain and success of inferior alveolar nerve block in Mandibular molars with symptomatic Irreversible Pulpitis: A Blinded Randomized Clinical Trial Therapeutic study

Condition or disease Intervention/treatment Phase
Postoperative Pain Drug: Dexamethasone Oral Tablet Drug: Placebo Early Phase 1

Detailed Description:

Participants, Interventions and Outcome

Setting:

Patients are of the clinic of endodontics at the faculty of oral and dental medicine, Cairo University, Urban area, Cairo governorate, Egypt.

  • The dental Unit is Adec 200 U.S.A.
  • The x-ray Machine is ViVi, S.r.I, Italy
  • The x-ray films are Kodac, speed D, size 2.
  • The operators are master degree students in the department of Endodontics.
  • No dental assistant
  • Time: 2017-2016

Procedure steps:

  1. Patients are asked to rate the pain level on numerical rating scale before the administration of drug to get the baseline record for the pain preoperatively.
  2. Thirty minutes before the endodontic procedure,dexamethasone (0.5 mg) or a placebo will be administered.Root canal therapy in all cases was completed in a single visit.
  3. After explanation of the treatment procedures (according to individual needs), the tooth will be anesthetized by an inferior alveolar nerve block (1.8 ml mepivacaine hydrochloride 2% 1: 100,000 epinephrine) using a side loading aspirating syringe and 27-gauge long needle.
  4. At 15-minutes post injection, access cavity will be performed using round bur size 4 and endo-z bur and the pain is recorded .
  5. Tooth is then isolated using rubber dam to prevent introduction of saliva and Bactria from the oral cavity.
  6. Checking the patency of the canal with K- file size 10 taper 0.02, extirpation of pulp with H-file size 15 taper 0.02 with recording the pain.
  7. Cleaning and shaping will be performed with a hybrid technique using hand K-files and rotary files for all teeth.
  8. Irrigation will be performed with 2.5% NaOCl after each instrument in all cases. At the end of instrumentation, the final irrigation will made by saline.
  9. After drying the canals with sterile paper points, they will be coated with AD-Seal sealer and obturated with gutta-percha using the lateral condensation technique.
  10. The tooth will be then temporized by using cavit temporary filling and reduced from occlusion.
  11. A rescue medication (ibuprofen) will be prescribed and the patients will be instructed to take it only if they experienced severe pain postoperatively. If rescue medication will be taken within the 48 hours after the treatment, then the patient will be excluded from the study.

Patients will be asked to make a mark on the point that represents level of perceived pain. (before the commencement of any treatment [baseline score]; at access and pulp extirpation, immediately after treatment completion; and 6, 12, 24, and 48 hours after the commencement of treatment). All subjects will be recalled after 2 days to return the pain diary and for a clinical evaluation.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: dexamethazone
Masking: Double (Participant, Care Provider)
Masking Description: investigator
Primary Purpose: Treatment
Official Title: A Comparative Evaluation of Effect of Dexamethazone on Postendodontic Pain and Success of Inferior Alveolar Nerve Block in Mandibular Molars With Symptomatic Irreversible Pulpitis
Estimated Study Start Date : July 12, 2017
Estimated Primary Completion Date : October 12, 2017
Estimated Study Completion Date : July 7, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Drug dexamethasone
preoperative single dose of dexamethasone 0.5 mg oral tablet given to patients before starting of root canal treatment by 30 minutes.
Drug: Dexamethasone Oral Tablet
single dose of tablet 0.5 mg dexamethasone given to patients before starting of root canal treatment by 30 minutes or placebo

Placebo Comparator: Placebo
Placebo will be administrated to patients before stating of root canal treatment
Drug: Placebo
Placebo will be administrated 30 minutes before start of root canal treatment




Primary Outcome Measures :
  1. Postoperative pain [ Time Frame: 48 hours ]
    Numerical rating scale


Secondary Outcome Measures :
  1. success of inferior alveolar nerve block [ Time Frame: 2 hours ]
    Numerical rating scale



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Patients in good health with no systemic disease (American Society of Anesthesiologists Class II)
  2. Patients having symptomatic irreversible pulpitis in one of their mandibular molars
  3. Age range is between 20 and 50 years
  4. Patients who can understand the categorical tool (points) for measurement
  5. Patients able to sign informed consent

Exclusion Criteria:

  1. Patients with positive percussion test
  2. Patients having history of necrosis with or without apical pathosis
  3. Patients have sinus tract or fistula extraoral or intraoral
  4. Patients having active pain in more than one molar
  5. Patients who had taken analgesics in the 12 hours preceding the preparation.
  6. Complicating systemic disease
  7. Subjects with allergies and hypersensitivity to or unable to take dexamethasone
  8. Teeth with grade 2 or 3 mobility

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03199482


Contacts
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Contact: mai M sayed, bachelore 01012232932 ext 2012 mai.safei247@gmail.com
Contact: amr M mansy, bachelore 01111663611 ext 2012 dr.amr.mansy.12@outlook.com

Locations
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Egypt
Faculty of Dentistry Recruiting
Cairo, Manyal, Egypt, 02
Contact: mai mohamed safei eldin, bachelore    0102232932 ext 2012    mai.safei247@gmail.com   
Sponsors and Collaborators
Cairo University
Investigators
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Study Director: Manar Hamouda, Professor Cairo University

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Responsible Party: Mai Mohamed Safei Eldin Sayed, Principle investigator, Cairo University
ClinicalTrials.gov Identifier: NCT03199482     History of Changes
Other Study ID Numbers: kinda
First Posted: June 27, 2017    Key Record Dates
Last Update Posted: June 27, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Dexamethasone
Dexamethasone acetate
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action