Comparison of a Prophylactic Intraligamentary Injection of Piroxicam Versus Mepecaine of Post-endodontic Pain

Not Applicable

• Conditions: Pulpitis - Irreversible
• Interventions: Procedure: intraligamentary injection piroxicam; Procedure: Intraligamentary mepevacaine

• Registration Number: NCT03006107
• Lead Sponsor: Cairo University

Brief Summary

to evaluate the effect of a single intraligamentary injection of piroxicam on postoperative pain associated with endodontic procedures.

Detailed Description

The pain after endodontic treatment is commonly severe in the first 24 hours after treatment, then it will reduce gradually until commonly disappearing after 7-10 days in most cases. Since piroxicam has a half-life of 50 hours in the plasma, it will be effective in controlling the most intense pain which occurs after endodontic treatment It appears that optimal clinical benefits can be achieved by administering drugs such as local anesthetics and NSAIDs before the onset of postoperative pain. Administering these drugs before a surgical or an endodontic procedure may be of benefit for longer procedures or for minimizing peripheral sensitization, which is a result of the cascade of inflammatory mediators that are released by tissue injury and fuel the subsequent inflammatory process

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Status Verified: 2016-12
• Study Start: 2016-12
• Study First Submitted: 2016-12-15
• Study First Submitted QC: 2016-12-27
• Last Update Submitted: 2016-12-27
• Study First Posted: 2016-12-30
• Last Update Posted: 2016-12-30
• Primary Completion: 2017-11
• Study Completion: 2018-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

• • Medically free patients

  • Patient's age between 25-50 years.
  • Molar or premolar teeth diagnosed clinically and radiographically with irreversible pulpitis and symptomatic apical periodontitis.
  • Positive patient's acceptance for participation in the study.
  • Sex include both male and female.
  • Patients who can understand Numerical Rating Scale (NRS)
  • Patients able to sign informed consent.

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Exclusion Criteria

• • Pregnancy or lactation in female patients

  • Medically compromised patients.
  • Patient with multiple teeth that required endodontic treatment to eliminate the possibility of pain referral.
  • Patient with fracture or mobile or mutilated teeth.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intraligamentary injection of piroxicam	intraligamentary injection piroxicam	intraligamentary injection Piroxicam is another NSAID that which has the ability for the treatment of pain, fever and inflammation in the body , has a half-life of 50h in the plasma , oral piroxicam reaches a peak concentration in the plasma within 2 to 4 hours . The needle will be placed in the gingival sulcus at a 30- degree angle to the long axis of the tooth then apical pressure is applied until the needle wedged into the periodontal ligament between the tooth and the alveolar crest of the bone
Intraligamentary mepevacaine	Intraligamentary mepevacaine	mepevacaine is an anesthetic (numbing medicine) that blocks the nerve impulses that send pain signals to brain . It is also used as an anesthetic for dental procedures.

Primary Outcome Measures

Name	Time	Method
The degree of postoperative pain at 6, 12, 24 and 48 postoperative hours which will be measured by Numeric Rate Scale , where the patient will be asked to rate the progress of pain on the NRS and inform the investigator with the results.	up to 48 hours	Primary outcome will be collected by the operator through Numerical Rating Scale (NRS)20 which is an 11-point scale consisting of numbers from 0 through 10; 0 reading represents "no pain" , 1- 3 readings represent "mild pain" , 4- 6 readings represent "moderate pain" , 7- 10 readings represent "severe pain" No or mild pain will be considered as success while moderate or severe pain will be regarded as failure.