Comparison Between Intraligamentary Piroxicam and Articaine

Cairo University (CU)

Status and phase: Unknown; Early Phase 1

Conditions: Pulpitis - Irreversible

Treatments: Drug: Intra-ligamentary Articaine; Drug: Intra-ligamentary Piroxicam

Study type: Interventional

Funder types: Other

Identifiers

NCT03612323

Piroxicam_Articaine

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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20 participants in 2 patient groups

Intra-ligamentary Piroxicam

Experimental group

Description:

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.

Treatment:

Drug: Intra-ligamentary Piroxicam

Intra-ligamentary Articaine

Active Comparator group

Description:

Articaine is a local anesthetic agent, will be administered by intraligamentary technique by injecting 0.4 milliliter (mL) of 4% articaine

Treatment:

Drug: Intra-ligamentary Articaine