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To compare the effect of using Etidronate in sodium hypochlorite versus sodium hypochlorite irrigating solution on:
Patients will be clinically and radiographically examined and their eligibility will be assessed Eligible patients will be treated in 2 visits
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| etidronate in sodium hypochlorite | Experimental | It comes in a capsule containing 0.9 g of etidronate powder, which should be mixed immediately with 10 mL of a NaOCl solution of choice directly before treatment, resulting in a combined irrigant containing both active chlorine and approximately 9% etidronate. Irrigation with a total volume of 25 ml for each case |
|
| sodium hypochlorite | Active Comparator | irrigation with 2.5% NaOCl with a total volume of 25 ml for each case |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| etidronate in sodium hypochlorite | Combination Product | using etidronate in sodium hypochlorite solution with a volume of 5 ml between each instrument to reach a total volume of 25 ml |
| Measure | Description | Time Frame |
|---|---|---|
| postoperative pain | intensity of pain by Numerical rating scale from 0-10 | upto 48 hours after 1st visit |
| Measure | Description | Time Frame |
|---|---|---|
| bacterial load reduction | pre and post instrumentation samples to count intracanal bacteria (CFU/ml) | 1 hour after root canal preparation |
| Measure | Description | Time Frame |
|---|---|---|
| matrix metalloproteinase | Periapical MMP-9 level will be determined by ELISA. | one week after root canal preparation |
Inclusion Criteria:
Patients who are free from any physical or mental handicapping condition with no underlying systemic disease.
Mandibular permanent premolar teeth:
Patients' acceptance to participate in the trial.
Patients who can understand pain scale and can sign the informed consent
Exclusion Criteria:
Need special treatment steps which could involve additional visits with incision and drainage. Also, it could influence initiation and progression of postoperative pain.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Laila Z Ismail, M.Sc. | Contact | +201223487628 | laila.zakaria1990@gmail.com | |
| Shaimaa I Gawdat, Ph.D | Contact | +201222235502 | Shaimaagawdat@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Laila Z Ismail, M.Sc. | Cairo University | Principal Investigator |
| Shaimaa I Gawdat, Ph.D | Cairo University | Study Chair |
| Randa El boghdadi, Ph.D |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27616541 | Background | Morago A, Ordinola-Zapata R, Ferrer-Luque CM, Baca P, Ruiz-Linares M, Arias-Moliz MT. Influence of Smear Layer on the Antimicrobial Activity of a Sodium Hypochlorite/Etidronic Acid Irrigating Solution in Infected Dentin. J Endod. 2016 Nov;42(11):1647-1650. doi: 10.1016/j.joen.2016.07.023. Epub 2016 Sep 8. | |
| 25515403 | Background |
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| ID | Term |
|---|---|
| D003790 | Dental Pulp Necrosis |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D003788 | Dental Pulp Diseases |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D009336 | Necrosis |
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| ID | Term |
|---|---|
| D012968 | Etidronic Acid |
| D012973 | Sodium Hypochlorite |
| ID | Term |
|---|---|
| D004164 | Diphosphonates |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
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| sodium hypochlorite | Combination Product | irrigation with 25 ml 2.5% sodium hypochlorite . 5ml between each instrument. |
|
| Cairo University |
| Study Director |
| Arias-Moliz MT, Ordinola-Zapata R, Baca P, Ruiz-Linares M, Garcia Garcia E, Hungaro Duarte MA, Monteiro Bramante C, Ferrer-Luque CM. Antimicrobial activity of Chlorhexidine, Peracetic acid and Sodium hypochlorite/etidronate irrigant solutions against Enterococcus faecalis biofilms. Int Endod J. 2015 Dec;48(12):1188-93. doi: 10.1111/iej.12424. Epub 2015 Jan 8. |
| 19220516 | Background | Lottanti S, Gautschi H, Sener B, Zehnder M. Effects of ethylenediaminetetraacetic, etidronic and peracetic acid irrigation on human root dentine and the smear layer. Int Endod J. 2009 Apr;42(4):335-43. doi: 10.1111/j.1365-2591.2008.01514.x. Epub 2009 Feb 7. |
| 30993696 | Background | Ballal NV, Gandhi P, Shenoy PA, Shenoy Belle V, Bhat V, Rechenberg DK, Zehnder M. Safety assessment of an etidronate in a sodium hypochlorite solution: randomized double-blind trial. Int Endod J. 2019 Sep;52(9):1274-1282. doi: 10.1111/iej.13129. Epub 2019 May 13. |
| 22515905 | Background | Paque F, Rechenberg DK, Zehnder M. Reduction of hard-tissue debris accumulation during rotary root canal instrumentation by etidronic acid in a sodium hypochlorite irrigant. J Endod. 2012 May;38(5):692-5. doi: 10.1016/j.joen.2011.12.019. Epub 2012 Jan 23. |
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D006997 |
| Hypochlorous Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |
| D017670 | Sodium Compounds |