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The aim of this prospective randomized clinical trial is to evaluate the effect of different apical size and taper preparation (35. 04; 35. 06; 45. 04 and 45. 06) on postoperative pain at 6, 12, 24, 48 and 72 hours, and intra-canal bacterial count in patients having mandibular premolars with necrotic pulps.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Root canal instrumentation EdgeFile X7 to size #35/0.06 | Experimental | The mechanical preparation will be continued using EdgeFile X7 #35 .04 and #35 .06 |
|
| Root canal instrumentation EdgeFile X7 to size #45/0.04 | Experimental | The mechanical preparation will be continued using EdgeFile X7 #35 .04, #40 .04 and #45 .04 |
|
| Root canal instrumentation EdgeFile X7 to size #45/0.06 | Experimental | The mechanical preparation will be continued using EdgeFile X7 #35 .04, #40 .04, #45 .04 and #45 .06 |
|
| Root canal instrumentation EdgeFile X7 to size #35/0.04 | Active Comparator | The mechanical preparation will be continued using EdgeFile X7 #35 .04 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Root canal instrumentation EdgeFile X7 to size #35/0.06 | Other | Instrumentation will be performed using an endodontic motor at a speed of 300 rpm and a torque of 2 Ncm |
|
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative pain | Postendodontic pain will be measured using Numerical Rating Scale. The Numerical Rating Scale consists of a 0-10 scale, with (0) meaning "no pain" and (10) meaning "the worst pain imaginable". No or mild pain response will be considered success. | up to 72 hours after endodontic treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Intra-canal bacterial reduction | Intra-canal bacterial count will be measured using a culture technique. The resultant growth will be visually quantified by counting the number of colony forming units per millilitre (CFUs/ mL) | Bacterial samples will be taken Immediately after root canal instrumentation. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nermeen Ibrahim, Master's | Contact | 01114323345 | 002 | nermin.awadallah@dentistry.cu.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Nermeen Ibrahim, Master's | Misr University for Science and Technology | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34058250 | Background | Fatima S, Kumar A, Andrabi SMUN, Mishra SK, Tewari RK. Effect of Apical Third Enlargement to Different Preparation Sizes and Tapers on Postoperative Pain and Outcome of Primary Endodontic Treatment: A Prospective Randomized Clinical Trial. J Endod. 2021 Sep;47(9):1345-1351. doi: 10.1016/j.joen.2021.05.010. Epub 2021 May 29. | |
| 28483164 |
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|
| Root canal instrumentation EdgeFile X7 to size #45/0.04 | Other | Instrumentation will be performed using an endodontic motor at a speed of 300 rpm and a torque of 2 Ncm |
|
|
| Root canal instrumentation EdgeFile X7 to size #45/0.06 | Other | Instrumentation will be performed using an endodontic motor at a speed of 300 rpm and a torque of 2 Ncm |
|
|
| Root canal instrumentation EdgeFile X7 to size #35/0.04 | Other | Instrumentation will be performed using an endodontic motor at a speed of 300 rpm and a torque of 2 Ncm |
|
|
| Rodrigues RCV, Zandi H, Kristoffersen AK, Enersen M, Mdala I, Orstavik D, Rocas IN, Siqueira JF Jr. Influence of the Apical Preparation Size and the Irrigant Type on Bacterial Reduction in Root Canal-treated Teeth with Apical Periodontitis. J Endod. 2017 Jul;43(7):1058-1063. doi: 10.1016/j.joen.2017.02.004. Epub 2017 May 5. |
| ID | Term |
|---|---|
| D003790 | Dental Pulp Necrosis |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D003788 | Dental Pulp Diseases |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D009336 | Necrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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