Celebrex Premedication in Teeth With Symptomatic Irreversible Pulpitis
Primary Purpose
Pulpitis
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Celebrex premedication
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Pulpitis
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Celebrex premedication
Placebo tablets
Arm Description
Celebrex is a NSAID with selective COX-2 inhibition properties, is given as an intervention to assess the pain
placebo tablets to compare the efficacy of Celebrex on the intra-operative and post-operative pain accompanying endodontic treatment of teeth with irreversible pulpits
Outcomes
Primary Outcome Measures
pain intensity (intra-operative pain)
pain intensity during endodontic treatment, measured by Visual Analogue Scale (pain scale)
Secondary Outcome Measures
alleviation of pain severity
severity of pain is measured by Visual Analogue Scale
number of analgesic tablets taken by the patient after endodontic treatment
counting the number of analgesic tablets taken by the patient after the treatment
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03339544
Brief Title
Celebrex Premedication in Teeth With Symptomatic Irreversible Pulpitis
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2017 (Anticipated)
Primary Completion Date
December 1, 2018 (Anticipated)
Study Completion Date
December 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulpitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
46 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Celebrex premedication
Arm Type
Experimental
Arm Description
Celebrex is a NSAID with selective COX-2 inhibition properties, is given as an intervention to assess the pain
Arm Title
Placebo tablets
Arm Type
Placebo Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
Celebrex premedication
Other Intervention Name(s)
Celecoxib
Intervention Description
celebrex (celecoxib) 200mg is a non-steroidal anti-infalmmatory drug with selective COX-2 inhibition.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
placebo is given as a tablet before initiation of endodontic treatment
Primary Outcome Measure Information:
Title
pain intensity (intra-operative pain)
Description
pain intensity during endodontic treatment, measured by Visual Analogue Scale (pain scale)
Time Frame
1 hour after administration of the drug up to 2 hours till the end of endodontic treatment
Secondary Outcome Measure Information:
Title
alleviation of pain severity
Description
severity of pain is measured by Visual Analogue Scale
Time Frame
24 hours
Title
number of analgesic tablets taken by the patient after endodontic treatment
Description
counting the number of analgesic tablets taken by the patient after the treatment
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yousra Khaled
Phone
+201003040660
Email
yousra.aly28@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Geraldine Ahmed
Phone
+201226322227
Email
geraldineahmed@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
15892672
Citation
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.
Results Reference
background
PubMed Identifier
26952243
Citation
Lapidus 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.
Results Reference
result
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Celebrex Premedication in Teeth With Symptomatic Irreversible Pulpitis
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