Celebrex Premedication in Teeth With Symptomatic Irreversible Pulpitis

NCT ID: NCT03339544

Last Updated: 2017-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-01

Study Completion Date

2019-12-31

Brief Summary

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

Detailed Description

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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).

Conditions

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Pulpitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Celebrex premedication

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

Group Type EXPERIMENTAL

Celebrex premedication

Intervention Type DRUG

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

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

placebo is given as a tablet before initiation of endodontic treatment

Interventions

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Celebrex premedication

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

Intervention Type DRUG

Placebo

placebo is given as a tablet before initiation of endodontic treatment

Intervention Type DRUG

Other Intervention Names

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Celecoxib

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Yousra Khaled Mohamed Ezzat

Resident at Endodontic department. Faculty of Oral and Dental Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Yousra Khaled

Role: CONTACT

Phone: +201003040660

Email: [email protected]

Geraldine Ahmed

Role: CONTACT

Phone: +201226322227

Email: [email protected]

References

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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.

Reference Type BACKGROUND
PMID: 15892672 (View on PubMed)

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.

Reference Type RESULT
PMID: 26952243 (View on PubMed)

Other Identifiers

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celebrex premedication

Identifier Type: -

Identifier Source: org_study_id