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the aim in this prospective in vivo randomized clinical trial to evaluate the influence of instrumentation technique ( reciprocation single file (wave one ) versus rotation single file (neolix) ) on post operative pain ( incidence ,degree and duration ) after endodontic treatment in single rooted lower premolars with symptomatic irreversible pulpits.
According to the inclusion criteria the patients enrolled in the study and allocated randomly into two groups either Wave One (group A) or Neolix ( group B) the endodontic treatment is done at single visit. firstly the patient's medical and dental history is taken .the patient assign on informed consent. and then,anaesthetized and access cavity performed and root canal preparation is done by either two systems and then irrigation and obturation is done. the patient record the post operative pain in sheet with NRS after 6,12,24,48hr and the operator will recall the patient to check the records and follow up the patient.
Medical and dental history: diagnostic charts will be collected in a case report form by the investigators and confirmed for eligibility with the assistant supervisor.
Radiographic examination : preoperative radiographs will be taken to examine the tooth structure,caries detection , periapical status .
Clinical examination : intraoral examination include visual examination for caries , restoration ,swelling ,fistula . mobility, percussion were done .
Diagnostic criteria for symptomatic irreversible pulpitis:
Intervention:
Forty four patients will included and they will be randomly divided into two groups A =root canal preparation with single reciprocating file (Wave One ® Dentsply , Switzerland) and B = Root canal preparation with single full rotation file (Neolix ® Neolix ,France) each group consisted from 22 patient .
Procedure steps :
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| neolix | Experimental | single full rotation file (Neolix ® Neolix ,France) the first file used is C1 file size 25 taper 12% as orifice opener and for coronal flaring for 2/3 of canal length the A1 file size 25 taper 8% in narrow or curved canals if size 10 K file (Mani Inc., Japan). is passively fit in the canal (most of the canals) , but in case of K-file (Mani Inc., Japan) size 20 loose in the canal so we choose large file size 40 taper 4% either of them to the full working length of the canal |
|
| wave one | Active Comparator | single reciprocating file (Wave One ® Dentsply , Switzerland) the canal preparation is done by primary file size 25 taper 8% in narrow or curved canals if size 10 K file (Mani Inc., Japan) is passively fit in the canal ( most of canals ) , but in case of K-file (Mani Inc., Japan) size 20 loose in the canal so we choose large large file size 40 taper 8% either of them to the full working length of the canal |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| neolix | Procedure | single rotation file |
| |
| wave one |
| Measure | Description | Time Frame |
|---|---|---|
| postoperative pain | intensity of postoperative pain after treatment by Numerical Rating Scale (0-10) | up to 48 hours after completion of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| yasmin hassan yousief, resident | Contact | 01146326683 | dr.yasmien90@yahoo.com | |
| alaa elbaz, ass. professor | Contact | 01000826286 |
| Name | Affiliation | Role |
|---|---|---|
| abeer marouzk, professor | faculty of oral and dental medicine -cairo university | Study Chair |
| alaa el baz, ass. professor | faculty of oral and dental medicine -cairo university | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17956561 | Background | Sathorn C, Parashos P, Messer H. The prevalence of postoperative pain and flare-up in single- and multiple-visit endodontic treatment: a systematic review. Int Endod J. 2008 Feb;41(2):91-9. doi: 10.1111/j.1365-2591.2007.01316.x. Epub 2007 Oct 23. | |
| 16448929 | Background | Tanalp J, Kaptan F, Sert S, Kayahan B, Bayirl G. Quantitative evaluation of the amount of apically extruded debris using 3 different rotary instrumentation systems. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2006 Feb;101(2):250-7. doi: 10.1016/j.tripleo.2005.03.002. Epub 2005 Oct 14. |
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| Procedure |
single reciprocation file |
|
| yasmin hassan yousief, resident | faculty of oral and dental medicine -cairo university | Principal Investigator |
| 14606784 | Background | Nekoofar MH, Sadeghipanah M, Dehpour AR. Evaluation of meloxicam (A cox-2 inhibitor) for management of postoperative endodontic pain: a double-blind placebo-controlled study. J Endod. 2003 Oct;29(10):634-7. doi: 10.1097/00004770-200310000-00005. |
| 19748294 | Background | Pochapski MT, Santos FA, de Andrade ED, Sydney GB. Effect of pretreatment dexamethasone on postendodontic pain. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2009 Nov;108(5):790-5. doi: 10.1016/j.tripleo.2009.05.014. Epub 2009 Sep 12. |
| 19826598 | Background | Ince B, Ercan E, Dalli M, Dulgergil CT, Zorba YO, Colak H. Incidence of postoperative pain after single- and multi-visit endodontic treatment in teeth with vital and non-vital pulp. Eur J Dent. 2009 Oct;3(4):273-9. |
| 21419285 | Background | Pak JG, White SN. Pain prevalence and severity before, during, and after root canal treatment: a systematic review. J Endod. 2011 Apr;37(4):429-38. doi: 10.1016/j.joen.2010.12.016. |