Celebrex Premedication in Teeth With Symptomatic Irreversible Pulpitis

Sponsor

Cairo University (Other)

Overall Status

Unknown status

CT.gov ID

NCT03339544

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Pulpitis	Drug: Celebrex premedication Drug: Placebo	N/A

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

Anticipated Enrollment :

46 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Dec 1, 2017

Anticipated Primary Completion Date :

Dec 1, 2018

Anticipated Study Completion Date :

Dec 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Celebrex premedication Celebrex is a NSAID with selective COX-2 inhibition properties, is given as an intervention to assess the pain	Drug: Celebrex premedication celebrex (celecoxib) 200mg is a non-steroidal anti-infalmmatory drug with selective COX-2 inhibition. Other Names: Celecoxib
Placebo Comparator: 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	Drug: Placebo placebo is given as a tablet before initiation of endodontic treatment

Arm

Intervention/Treatment

Experimental: Celebrex premedication

Celebrex is a NSAID with selective COX-2 inhibition properties, is given as an intervention to assess the pain

Drug: Celebrex premedication

celebrex (celecoxib) 200mg is a non-steroidal anti-infalmmatory drug with selective COX-2 inhibition.

Other Names:

Celecoxib

Placebo Comparator: 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

Drug: Placebo

placebo is given as a tablet before initiation of endodontic treatment

Outcome Measures

Primary Outcome Measures

pain intensity (intra-operative pain) [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 Outcome Measures

alleviation of pain severity [24 hours]
severity of pain is measured by Visual Analogue Scale
number of analgesic tablets taken by the patient after endodontic treatment [24 hours]
counting the number of analgesic tablets taken by the patient after the treatment

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 40 Years

Sexes Eligible for Study:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

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.

Responsible Party:

Yousra Khaled Mohamed Ezzat, Resident at Endodontic department. Faculty of Oral and Dental Medicine, Cairo University

ClinicalTrials.gov Identifier:

NCT03339544

Other Study ID Numbers:

celebrex premedication

First Posted:

Nov 13, 2017

Last Update Posted:

Nov 13, 2017

Last Verified:

Nov 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Pulpitis

Celecoxib

Study Results

No Results Posted as of Nov 13, 2017