Celebrex Premedication in Teeth With Symptomatic Irreversible Pulpitis

Pulpitis Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03339544
• Other study ID #: celebrex premedication
• Status: Not yet recruiting
• Phase: N/A
• First received: November 1, 2017
• Last updated: November 9, 2017
• Start date: December 1, 2017
• Est. completion date: December 2019

Study information

• Verified date: November 2017
• Source: Cairo University
• Contact: Yousra Khaled
• Phone: +201003040660
• Email: yousra.aly28[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Assessing the efficacy of Celebrex premedication on pain during and after endodontic treatment in teeth with symptomatic irreversible pulpits

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 46
• Est. completion date: December 2019
• Est. primary completion date: December 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Pulpitis

Intervention

Drug:
• Celebrex premedication
celebrex (celecoxib) 200mg is a non-steroidal anti-infalmmatory drug with selective COX-2 inhibition.
• Placebo
placebo is given as a tablet before initiation of endodontic treatment

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

References & Publications (2)

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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	alleviation of pain severity	severity of pain is measured by Visual Analogue Scale	24 hours
Secondary	number of analgesic tablets taken by the patient after endodontic treatment	counting the number of analgesic tablets taken by the patient after the treatment	24 hours