Effect of Celebrex Pre-medication on the Intra and Post-treatment Endodontic Pain in Teeth With Symptomatic Irreversible Pulpitis: Double Blind Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Cairo University
- Enrollment
- 46
- Primary Endpoint
- pain intensity (intra-operative pain)
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 20 Years to 40 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Celebrex premedication
Celebrex is a NSAID with selective COX-2 inhibition properties, is given as an intervention to assess the pain
Intervention: Celebrex premedication (Drug)
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: Placebo (Drug)
Outcomes
Primary Outcomes
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 Outcomes
- alleviation of pain severity(24 hours)
- number of analgesic tablets taken by the patient after endodontic treatment(24 hours)
Investigators
Yousra Khaled Mohamed Ezzat
Resident at Endodontic department. Faculty of Oral and Dental Medicine
Cairo University