Comparison Between Intraligamentary Piroxicam and Articaine

Pulpitis - Irreversible Clinical Trial

Official title:

Comparative Evaluation of the Efficacy of Intra-ligamentary Injection of 20 Milligram (Mg) Piroxicam Versus 4% Articaine in Management of Endodontic Pain in Patients With Symptomatic Irreversible Pulpitis in Mandibular Molars

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03612323
• Other study ID #: Piroxicam_Articaine
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: November 2018
• Est. completion date: August 2019

Study information

• Verified date: August 2018
• Source: Cairo University
• Contact: Lobna Elhadad, student
• Phone: +201279811117
• Email: lobna.elhadad[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: August 2019
• Est. primary completion date: May 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

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.

Related Conditions & MeSH terms

• Pulpitis
• Pulpitis - Irreversible

Intervention

Drug:
• Intra-ligamentary Piroxicam
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
• Intra-ligamentary Articaine
Articaine is a local anesthetic agent , has been reported to be an effective anesthetic in controlling pain during root canal treatment

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Alleviation of post-operative pain severity	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.	up to 48 hours
Secondary	Intra-operative pain during access cavity preparation and instrumentation which will be measured ny Numerical Rating Scale (NRS)	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.	immediately after injection of the drug up to 2 hours till end of endodontic treatment