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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intra-ligamentary Piroxicam | Experimental | 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. |
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| Intra-ligamentary Articaine | Active Comparator | Articaine is a local anesthetic agent, will be administered by intraligamentary technique by injecting 0.4 milliliter (mL) of 4% articaine |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intra-ligamentary Piroxicam | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lobna Elhadad, student | Contact | +201279811117 | lobna.elhadad@dentistry.cu.edu.eg | |
| Marwa Bedeir | Contact | +201006611104 | M.bedeir81@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Lobna Elhadad, Student | Cairo University | Principal Investigator |
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| ID | Term |
|---|---|
| D010894 | Piroxicam |
| D002355 | Carticaine |
| ID | Term |
|---|---|
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| Intra-ligamentary Articaine | Drug | Articaine is a local anesthetic agent , has been reported to be an effective anesthetic in controlling pain during root canal treatment |
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| immediately after injection of the drug up to 2 hours till end of endodontic treatment |
| D006571 |
| Heterocyclic Compounds |
| D013876 | Thiophenes |