Celebrex Premedication in Teeth With Symptomatic Irreversible Pulpitis

Not Applicable

• Conditions: Pulpitis
• Interventions: Drug: Celebrex premedication; Drug: Placebo

• Registration Number: NCT03339544
• Lead Sponsor: Cairo University

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 Timeline

• Status Verified: 2017-11
• Study First Submitted: 2017-11-01
• Study First Submitted QC: 2017-11-09
• Last Update Submitted: 2017-11-09
• Study First Posted: 2017-11-13
• Last Update Posted: 2017-11-13
• Study Start: 2017-12-01
• Primary Completion: 2018-12-01
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 46

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Celebrex premedication	Celebrex premedication	Celebrex is a NSAID with selective COX-2 inhibition properties, is given as an intervention to assess the pain
Placebo tablets	Placebo	placebo tablets to compare the efficacy of Celebrex on the intra-operative and post-operative pain accompanying endodontic treatment of teeth with irreversible pulpits

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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