Clinical trial NCT03612323: Comparison Between Intraligamentary Piroxicam and Articaine
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Pulpitis - Irreversible
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-08-02
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Alleviation of post-operative pain severity
timeFrame: up to 48 hours
Secondary outcomes:
measure: Intra-operative pain during access cavity preparation and instrumentation which will be measured ny Numerical Rating Scale (NRS)
timeFrame: immediately after injection of the drug up to 2 hours till end of endodontic treatment
Other outcomes:
Locations:
Study officials:
affiliation: Cairo University
name: Lobna Elhadad, Student
role: PRINCIPAL_INVESTIGATOR
References: