Clinical trial NCT03339544: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Pulpitis
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-11-13
Enrollment: 46
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: pain intensity (intra-operative pain)
timeFrame: 1 hour after administration of the drug up to 2 hours till the end of endodontic treatment
Secondary outcomes:
measure: alleviation of pain severity
timeFrame: 24 hours
measure: number of analgesic tablets taken by the patient after endodontic treatment
timeFrame: 24 hours
Other outcomes:
Locations:
Study officials:
References:
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.
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.