Comparison Between Intraligamentary Piroxicam and Articaine
Primary Purpose
Pulpitis - Irreversible
Status
Unknown status
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Intra-ligamentary Piroxicam
Intra-ligamentary Articaine
Sponsored by

About this trial
This is an interventional prevention trial for Pulpitis - Irreversible
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intra-ligamentary Piroxicam
Intra-ligamentary Articaine
Arm 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.
Articaine is a local anesthetic agent, will be administered by intraligamentary technique by injecting 0.4 milliliter (mL) of 4% articaine
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03612323
Brief Title
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
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
November 2018 (Anticipated)
Primary Completion Date
May 2019 (Anticipated)
Study Completion Date
August 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulpitis - Irreversible
7. Study Design
Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intra-ligamentary Piroxicam
Arm Type
Experimental
Arm 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.
Arm Title
Intra-ligamentary Articaine
Arm Type
Active Comparator
Arm Description
Articaine is a local anesthetic agent, will be administered by intraligamentary technique by injecting 0.4 milliliter (mL) of 4% articaine
Intervention Type
Drug
Intervention Name(s)
Intra-ligamentary Piroxicam
Other Intervention Name(s)
Feldene
Intervention Description
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
Intervention Name(s)
Intra-ligamentary Articaine
Other Intervention Name(s)
Articaine
Intervention Description
Articaine is a local anesthetic agent , has been reported to be an effective anesthetic in controlling pain during root canal treatment
Primary Outcome Measure Information:
Title
Alleviation of post-operative pain severity
Description
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.
Time Frame
up to 48 hours
Secondary Outcome Measure Information:
Title
Intra-operative pain during access cavity preparation and instrumentation which will be measured ny Numerical Rating Scale (NRS)
Description
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.
Time Frame
immediately after injection of the drug up to 2 hours till end of endodontic treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lobna Elhadad, student
Phone
+201279811117
Email
lobna.elhadad@dentistry.cu.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Marwa Bedeir
Phone
+201006611104
Email
M.bedeir81@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lobna Elhadad, Student
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
12. IPD Sharing Statement
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Comparison Between Intraligamentary Piroxicam and Articaine
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