Celebrex Premedication in Teeth With Symptomatic Irreversible Pulpitis
Effect of Celebrex Pre-medication on the Intra and Post-treatment Endodontic Pain in Teeth With Symptomatic Irreversible Pulpitis: Double Blind Randomized Clinical Trial
1 other identifier
interventional
46
0 countries
N/A
Brief Summary
Assessing the efficacy of Celebrex premedication on pain during and after endodontic treatment in teeth with symptomatic irreversible pulpits
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2017
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 1, 2017
CompletedFirst Posted
Study publicly available on registry
November 13, 2017
CompletedStudy Start
First participant enrolled
December 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedNovember 13, 2017
November 1, 2017
1 year
November 1, 2017
November 9, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
pain intensity (intra-operative pain)
pain intensity during endodontic treatment, measured by Visual Analogue Scale (pain scale)
1 hour after administration of the drug up to 2 hours till the end of endodontic treatment
Secondary Outcomes (2)
alleviation of pain severity
24 hours
number of analgesic tablets taken by the patient after endodontic treatment
24 hours
Study Arms (2)
Celebrex premedication
EXPERIMENTALCelebrex is a NSAID with selective COX-2 inhibition properties, is given as an intervention to assess the pain
Placebo tablets
PLACEBO COMPARATORplacebo tablets to compare the efficacy of Celebrex on the intra-operative and post-operative pain accompanying endodontic treatment of teeth with irreversible pulpits
Interventions
celebrex (celecoxib) 200mg is a non-steroidal anti-infalmmatory drug with selective COX-2 inhibition.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Related Publications (2)
Lee Y, Rodriguez C, Dionne RA. The role of COX-2 in acute pain and the use of selective COX-2 inhibitors for acute pain relief. Curr Pharm Des. 2005;11(14):1737-55. doi: 10.2174/1381612053764896.
PMID: 15892672BACKGROUNDLapidus D, Goldberg J, Hobbs EH, Ram S, Clark GT, Enciso R. Effect of premedication to provide analgesia as a supplement to inferior alveolar nerve block in patients with irreversible pulpitis. J Am Dent Assoc. 2016 Jun;147(6):427-37. doi: 10.1016/j.adaj.2016.01.006. Epub 2016 Mar 4.
PMID: 26952243RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Resident at Endodontic department. Faculty of Oral and Dental Medicine
Study Record Dates
First Submitted
November 1, 2017
First Posted
November 13, 2017
Study Start
December 1, 2017
Primary Completion
December 1, 2018
Study Completion
December 1, 2019
Last Updated
November 13, 2017
Record last verified: 2017-11
Data Sharing
- IPD Sharing
- Will not share