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Celebrex Premedication in Teeth With Symptomatic Irreversible Pulpitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03339544
Recruitment Status : Unknown
Verified November 2017 by Yousra Khaled Mohamed Ezzat, Cairo University.
Recruitment status was:  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

Tracking Information
First Submitted Date  ICMJE November 1, 2017
First Posted Date  ICMJE November 13, 2017
Last Update Posted Date November 13, 2017
Estimated Study Start Date  ICMJE December 1, 2017
Estimated Primary Completion Date December 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 9, 2017)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: November 9, 2017)
  • alleviation of pain severity [ Time Frame: 24 hours ]
    severity of pain is measured by Visual Analogue Scale
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Celebrex Premedication in Teeth With Symptomatic Irreversible Pulpitis
Official Title  ICMJE Effect of Celebrex Pre-medication on the Intra and Post-treatment Endodontic Pain in Teeth With Symptomatic Irreversible Pulpitis: Double Blind Randomized Clinical Trial
Brief Summary Assessing the efficacy of Celebrex premedication on pain during and after endodontic treatment in teeth with symptomatic irreversible pulpits
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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Pulpitis
Intervention  ICMJE
  • Drug: Celebrex premedication
    celebrex (celecoxib) 200mg is a non-steroidal anti-infalmmatory drug with selective COX-2 inhibition.
    Other Name: Celecoxib
  • Drug: Placebo
    placebo is given as a tablet before initiation of endodontic treatment
Study Arms  ICMJE
  • Experimental: Celebrex premedication
    Celebrex is a NSAID with selective COX-2 inhibition properties, is given as an intervention to assess the pain
    Intervention: Drug: Celebrex premedication
  • 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
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 9, 2017)
46
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date December 1, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03339544
Other Study ID Numbers  ICMJE celebrex premedication
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Yousra Khaled Mohamed Ezzat, Cairo University
Study Sponsor  ICMJE Cairo University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Cairo University
Verification Date November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP