Comparison Between Intraligamentary Piroxicam and Articaine

Early Phase 1

• Conditions: Pulpitis - Irreversible
• Interventions: Drug: Intra-ligamentary Piroxicam; Drug: Intra-ligamentary Articaine

• Registration Number: NCT03612323
• Lead Sponsor: Cairo University

Brief Summary

Comparing the efficacy of intra-ligamentary Piroxicam and intra-ligamentary Articaine on pain during and after endodontic treatment of mandibular molars with symptomatic irreversible pulpitis.

Detailed Description

Owing to the painful nature of endodontic treatment in teeth with symptomatic irreversible pulpitis and difficulty in achieving effective anesthesia particularly in mandibular molars due to various factors such as different bony landmarks, anatomical variations, needle deflection, accessory innervation, so local anesthesia isn't enough in such cases. Piroxicam is a long-acting potent analgesic non selective oxicams derivative, has a half-life of 50 hrs in the plasma.The onset of action of oral Piroxicam is 2-4 hrs, but it is anticipated that injectable piroxicam could produce more rapid onset of action. It could favourably overcome the intense pain up to 48 hrs following the treatment. It is also postulated that the intraligamentary injection enables the application of anti-inflammatory agents in the periapical intraosseous region. Moreover, intra-ligamentary injection of local anesthesia was reported to be an effective and easy way to control severe pain during endodontic treatment mainly in mandibular teeth which are more difficult than maxillary teeth , thus piroxicam may be effective as an adjuvant drug to support the action of local anesthetics.

Study Timeline

• Study First Submitted: 2018-07-16
• Status Verified: 2018-08
• Study First Submitted QC: 2018-08-01
• Last Update Submitted: 2018-08-01
• Study First Posted: 2018-08-02
• Last Update Posted: 2018-08-02
• Study Start: 2018-11
• Primary Completion: 2019-05
• Study Completion: 2019-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Healthy and medically free patients.
• Acute symptomatic irreversible pulpitis of the mandibular first or second molar teeth.
• Vital teeth with no history of previous root canal treatment.
• Teeth that could be treated endodontically in single visit.
• Teeth with normal periodontium, not sensitive to percussion with no periapical radiolucency.
• Patients able to understand numerical rating scale and sign the informed consent.

Read More

Exclusion Criteria

• Known hypersensitivity to piroxicam.
• Pregnancy or lactation.
• Asthma or allergy to other anti-inflammatory drugs.
• History of peptic ulceration.
• Teeth associated with swelling or fistulous tract, acute or chronic periapical abscess.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intra-ligamentary Piroxicam	Intra-ligamentary Piroxicam	Piroxicam is a long acting potent Non steroidal anti-inflammatory drug (NSAID)with half life of 50 hours in plasma, is given as intervention to assess the pain,will be administered by intra-ligamentary technique by injecting 0.4 milliliter (mL) of 20 milligram (Mg) piroxicam.
Intra-ligamentary Articaine	Intra-ligamentary Articaine	Articaine is a local anesthetic agent, will be administered by intraligamentary technique by injecting 0.4 milliliter (mL) of 4% articaine

Primary Outcome Measures

Name	Time	Method
Alleviation of post-operative pain severity	up to 48 hours	the patient will be asked to rate the progress of pain on the NRS and inform the investigator with the results,Primary outcome will be collected by the operator through Numerical Rating Scale (NRS) 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.

Secondary Outcome Measures

Name	Time	Method
Intra-operative pain during access cavity preparation and instrumentation which will be measured ny Numerical Rating Scale (NRS)	immediately after injection of the drug up to 2 hours till end of endodontic treatment	the patient will be asked to rate the progress of pain on the NRS and inform the investigator with the results,secondary outcome will be assessed through Numerical Rating Scale (NRS) 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.