Comparison Between Intraligamentary Piroxicam and Articaine

NCT ID: NCT03612323

Last Updated: 2018-08-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-30
• Study Completion Date: 2019-08-31

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.

Conditions

Pulpitis - Irreversible

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Intra-ligamentary Piroxicam

Intervention Type: DRUG

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, will be administered by intraligamentary technique by injecting 0.4 milliliter (mL) of 4% articaine

Group Type: ACTIVE_COMPARATOR

Intra-ligamentary Articaine

Intervention Type: DRUG

Articaine is a local anesthetic agent , has been reported to be an effective anesthetic in controlling pain during root canal treatment

Interventions

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

Intervention Type: DRUG

Intra-ligamentary Articaine

Articaine is a local anesthetic agent , has been reported to be an effective anesthetic in controlling pain during root canal treatment

Intervention Type: DRUG

Other Intervention Names

Feldene; Articaine

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Lobna Elhadad

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lobna Elhadad, Student

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Central Contacts

Lobna Elhadad, student

Role: CONTACT

lobna.elhadad@dentistry.cu.edu.eg

+201279811117

Marwa Bedeir

Role: CONTACT

M.bedeir81@gmail.com

+201006611104

Other Identifiers

Piroxicam_Articaine

Identifier Type: -

Identifier Source: org_study_id