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Celebrex Premedication in Teeth With Symptomatic Irreversible Pulpitis

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ClinicalTrials.gov Identifier: NCT03339544
Recruitment Status : Not yet recruiting
First Posted : November 13, 2017
Last Update Posted : November 13, 2017
Sponsor:
Information provided by (Responsible Party):
Yousra Khaled Mohamed Ezzat, Cairo University

Brief Summary:
Assessing the efficacy of Celebrex premedication on pain during and after endodontic treatment in teeth with symptomatic irreversible pulpits

Condition or disease Intervention/treatment Phase
Pulpitis Drug: Celebrex premedication Drug: Placebo Not Applicable

Detailed Description:

Owing to the painful nature of endodotnic treatment in teeth with irreversible pulpits, administration of an analgesic and anti-inflammatory could help to lessen the perception of pain, hence decreasing the patient apprehension.

Previous clinical trials have shown that the use of NSAIDS as a premedication prior to endodontic treatment was effective in reducing the pain and increasing the anesthetic success, since as high as 80% of the patients with pre-operative pain experience pain after endodontic treatment.

In this study, Celebrex (Celecoxib) 200mg will be given to the patients 1 hour before initiation of the treatment, and its effect on reducing the pain will be compared with a placebo.

Celebrex being a selective COX-2 inhibitor, it will spare the physiological tissue prostaglandin production while inhibiting the inflammatory prostaglandin production thus allow for effective analgesia with fewer side effects than Non-Selective NSAIDS (nsNSAIDS).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Celebrex Pre-medication on the Intra and Post-treatment Endodontic Pain in Teeth With Symptomatic Irreversible Pulpitis: Double Blind Randomized Clinical Trial
Estimated Study Start Date : December 1, 2017
Estimated Primary Completion Date : December 1, 2018
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Celecoxib

Arm Intervention/treatment
Experimental: Celebrex premedication
Celebrex is a NSAID with selective COX-2 inhibition properties, is given as an intervention to assess the pain
Drug: Celebrex premedication
celebrex (celecoxib) 200mg is a non-steroidal anti-infalmmatory drug with selective COX-2 inhibition.
Other Name: Celecoxib

Placebo Comparator: Placebo tablets
placebo tablets to compare the efficacy of Celebrex on the intra-operative and post-operative pain accompanying endodontic treatment of teeth with irreversible pulpits
Drug: Placebo
placebo is given as a tablet before initiation of endodontic treatment




Primary Outcome Measures :
  1. pain intensity (intra-operative pain) [ Time Frame: 1 hour after administration of the drug up to 2 hours till the end of endodontic treatment ]
    pain intensity during endodontic treatment, measured by Visual Analogue Scale (pain scale)


Secondary Outcome Measures :
  1. alleviation of pain severity [ Time Frame: 24 hours ]
    severity of pain is measured by Visual Analogue Scale

  2. number of analgesic tablets taken by the patient after endodontic treatment [ Time Frame: 24 hours ]
    counting the number of analgesic tablets taken by the patient after the treatment



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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Medically free patients
  • Patients able to understand Visual Analogue Scale and sign the informed conset

Mandibular molar teeth with:

  • Preoperative sharp pain
  • Vital pulp tissue
  • Normal peripaical radiographic appearance or slight widening of the lamina dura

Exclusion Criteria:

  • Patients allergic to NSAIDS
  • Pregnant females
  • Patients having significant systemic disorder
  • Patients with psychological disturbances
  • Patients with bruxism or clenching

Teeth that have:

  • Associated with swelling or fistulous tract
  • Acute or chronic periapical abscess
  • Greater than grade I mobility
  • Periodontitis
  • No possible restorability
  • previous endodontic treatment

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): NCT03339544


Contacts
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Contact: Yousra Khaled +201003040660 yousra.aly28@gmail.com
Contact: Geraldine Ahmed +201226322227 geraldineahmed@gmail.com

Sponsors and Collaborators
Cairo University

Publications of Results:
Other Publications:
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Responsible Party: Yousra Khaled Mohamed Ezzat, Resident at Endodontic department. Faculty of Oral and Dental Medicine, Cairo University
ClinicalTrials.gov Identifier: NCT03339544     History of Changes
Other Study ID Numbers: celebrex premedication
First Posted: November 13, 2017    Key Record Dates
Last Update Posted: November 13, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Celecoxib
Pulpitis
Dental Pulp Diseases
Tooth Diseases
Stomatognathic Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action