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The study compares the post operative pain after root canal therapy, after using different irrigation protocols. The subjects are divided into 3 groups and different irrigation protocol is used in each group. One group undergoes final irrigation after root canal therapy with a sonic activation device, and in the other two groups, side-vented and open-ended needles are used. Post operative pain is then compared at 8, 24, and 48 hour intervals.
Root canal therapy is a procedure in which inflamed pulp tissue and microorganisms are removed from root canals and pulp chamber, in order to eradicate infection and symptoms. Irrigation is a crucial step of an endodontic therapy and different methods and protocols are used to enhance the efficacy of irrigation. Sonic activation of root canal irrigation agent is one of the effective methods that enhance the outcomes and success rate of endo therapies. It removes the smear layer, bacterial biofilms and debris by acoustic streaming and agitating the irrigant inside root canals. Similarly, irrigation needles also play an important role in endodontic therapy, particularly by improving the delivery of irrigation agent to the apex of a root canal. conventionally, open ended needles have been used for irrigant delivery inside root canal but is not deemed very efficacious as they cannot penetrate deep into canals and cause extrusion of debris beyond the apex. This problem is solved by using side vented needles of smaller gauge (30 G) that leads to better irrigation and prevent extrusion of chemicals and debris outside the root apex.
In this study, the efficacy of all three different irrigation protocols will be compared and assessed based on post-operative pain, measured by Visual Analog Scale (VAS).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A - Open-ended needle | Experimental | Open ended needle group. Irrigation in this group shall be done using a conventional open-ended needle during root canal therapy |
|
| Group B- side-vented needle | Experimental | Side vented needle group. Irrigation in this group shall be done using a 30G side-vented needle during root canal therapy |
|
| Group C- Endoactivator | Experimental | Sonic activation group. In this group, final irrigation during endodontic therapy shall be done using a sonic activation device (Endoactivator) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Open ended needle irrigation | Device | irrigation during root canal shaping and cleaning using an open-ended needle |
|
| Measure | Description | Time Frame |
|---|---|---|
| Post Operative pain assessed by VAS after endodontic therapy | comparative evaluation of post operative pain after using different irrigation devices, using VAS (Visual Analog Scale). It is drawn as a straight line of 10 inches and marked in numbers which show intensity of pain, from 0-10, with 0 being no pain at all to10 being the worst pain imaginable. In detail, it is a scale which shows pain intensity in ascending order and can also be used to analyze the intensity of pain experienced by the patient. 0: No pain at all 1-3: mild pain 4-6: moderate pain 7-9: severe pain 10: worst pain imaginable | 1 week |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Athar Ali, BDS | Classified Specialist | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Armed Forces Institute of dentistry | Rawalpindi | Punjab Province | 64000 | Pakistan |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Feb 2, 2024 |
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Patients to be divided randomly into three groups after fulfilling the Inclusion Criteria, and not told about the specific intervention being done. Care provider/investigator knows which device they are using, while outcomes accessor is also masked.
| side vented needle irrigation | Device | irrigation during root canal shaping and cleaning using a 30-guage side-vented needle |
|
| Sonic activation | Device | Agitation of root canal irrigation solution with a sonic activation device (Endoactivator). |
|
| Feb 4, 2024 |
| Prot_SAP_ICF_000.pdf |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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