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| Name | Class |
|---|---|
| Alexandria University | OTHER |
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The aim of the present study is to assess clinically and radio-graphically the regenerative potential of immature permanent teeth with necrotic pulp using blood clot and Platelet rich fibrin scaffolds.
30 immature necrotic permanent teeth in patients will be allocated and divided into two groups. Group 1 will be treated by regenerative procedure using blood clot as a scaffold and Group 2 will be treated with regenerative procedures using combined blood clot and Platelet rich fibrin as a scaffold.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Induced blood clot scaffold | Active Comparator |
| |
| Induced blood clot scaffold combined with Platelet rich fibrin | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood clot scaffold | Biological | Bleeding will be induced in the canal by passing a size 30 sterile K-file 3 mm beyond the apex with the goal of having the entire canal filled with blood to the level of the cemento-enamel junction. Bleeding will be stopped just below the cemento enamel junction. Biodentine will be placed approximately 3-4 mm below the cementoenamel junction. |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective pain assessment | The patient will be asked about the presence of any pain or discomfort. Pain severity will be categorized as: no pain - mild pain - moderate pain - severe pain | 1 month |
| Subjective pain assessment | The patient will be asked about the presence of any pain or discomfort. Pain severity will be categorized as: no pain - mild pain - moderate pain - severe pain | 3 months |
| Subjective pain assessment | The patient will be asked about the presence of any pain or discomfort. Pain severity will be categorized as: no pain - mild pain - moderate pain - severe pain | 6 months |
| Subjective pain assessment | The patient will be asked about the presence of any pain or discomfort. Pain severity will be categorized as: no pain - mild pain - moderate pain - severe pain | 12 months |
| Assessment of pulp vitality | Pulp vitality will be assessed using thermal and electric pulp sensibility tests | 1 month |
| Assessment of pulp vitality | Pulp vitality will be assessed using thermal and electric pulp sensibility tests | 3 months |
| Assessment of pulp vitality | Pulp vitality will be assessed using thermal and electric pulp sensibility tests |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mahmoud MS Hassan, M.Sc | Faculty of Dentistry, Alexandria University, Egypt | Principal Investigator |
| Mohamed Ibrahim, PhD | Faculty of Dentistry, Alexandria University, Egypt | Study Director |
| Sybel M Moussa, PhD | Faculty of Dentistry, Alexandria University, Egypt | Study Director |
| Nihal A Lehita, PhD | Faculty of Dentistry, Alexandria University, Egypt | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dentistry, Alexandria University | Alexandria | 21512 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25219066 | Background | Bakhtiar H, Vatanpour M, Rayani A, Navi F, Asna-Ashari E, Ahmadi A, Jafarzadeh H. The plasma-rich in growth factor as a suitable matrix in regenerative endodontics: a case series. N Y State Dent J. 2014 Jun-Jul;80(4):49-53. | |
| 23581794 | Background | Keswani D, Pandey RK. Revascularization of an immature tooth with a necrotic pulp using platelet-rich fibrin: a case report. Int Endod J. 2013 Nov;46(11):1096-104. doi: 10.1111/iej.12107. Epub 2013 Apr 13. |
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| ID | Term |
|---|---|
| D003790 | Dental Pulp Necrosis |
| ID | Term |
|---|---|
| D003788 | Dental Pulp Diseases |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D009336 | Necrosis |
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| ID | Term |
|---|---|
| D056690 | Prolactin-Releasing Hormone |
| ID | Term |
|---|---|
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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The radiographic specialist and the statistician will be blinded to treatment group
|
| Blood clot scaffold combined with PRF | Biological | Platelet-rich fibrin will be prepared by drawing the patient blood into a 10mL test tube without the addition of an anticoagulant. To prevent the blood from coagulating after coming in contact with the glass tube, it will be centrifuged immediately using a table top centrifuge** at 400 g force for 12 minutes. Then platelet-rich fibrin membrane will be placed into the canal space to a level 3 mm below the cemento-enamel junction using hand plugger following the induction of apical bleeding by passing a number 30 sterile hand file 3 mm beyond the apex of the tooth. Biodentine cap will be placed over the platelet-rich fibrin scaffold. |
|
| 6 months |
| Assessment of pulp vitality | Pulp vitality will be assessed using thermal and electric pulp sensibility tests | 12 months |
| Assessment of root development | Continued root development will be assessed using cone beam computed tomography (CBCT) and compared with the contra-lateral healthy tooth | 1 month |
| Assessment of root development | Continued root development will be assessed using cone beam computed tomography (CBCT) and compared with the contra-lateral healthy tooth | 3 months |
| Assessment of root development | Continued root development will be assessed using cone beam computed tomography (CBCT) and compared with the contra-lateral healthy tooth | 6 months |
| Assessment of root development | Continued root development will be assessed using cone beam computed tomography (CBCT) and compared with the contra-lateral healthy tooth | 12 months |
| Assessment of the size of periapical radiolucency | Size of the lesion will be assessed using the periapical index score. The PAI provides an ordinal scale of 5 scores ranging from 1 (healthy) to 5 (severe periodontitis with exacerbating features). | 1 month |
| Assessment of the size of periapical radiolucency | Size of the lesion will be assessed using Cone Beam Computed Tomography (CBCT). | 1 month |
| Assessment of the size of periapical radiolucency | Size of the lesion will be assessed using the periapical index (PAI) score. The PAI provides an ordinal scale of 5 scores ranging from 1 (healthy) to 5 (severe periodontitis with exacerbating features). | 3 months |
| Assessment of the size of periapical radiolucency | Size of the lesion will be assessed using Cone Beam Computed Tomography (CBCT). | 3 months |
| Assessment of the size of periapical radiolucency | Size of the lesion will be assessed using the periapical index (PAI) score. The PAI provides an ordinal scale of 5 scores ranging from 1 (healthy) to 5 (severe periodontitis with exacerbating features). | 6 months |
| Assessment of the size of periapical radiolucency | Size of the lesion will be assessed using Cone Beam Computed Tomography (CBCT). | 6 months |
| Assessment of the size of periapical radiolucency | Size of the lesion will be assessed using the periapical index (PAI) score. The PAI provides an ordinal scale of 5 scores ranging from 1 (healthy) to 5 (severe periodontitis with exacerbating features). | 12 months |
| Assessment of the size of periapical radiolucency | Size of the lesion will be assessed using Cone Beam Computed Tomography (CBCT). | 12 months |
| 25984471 | Background | Yassen GH, Eckert GJ, Platt JA. Effect of intracanal medicaments used in endodontic regeneration procedures on microhardness and chemical structure of dentin. Restor Dent Endod. 2015 May;40(2):104-12. doi: 10.5395/rde.2015.40.2.104. Epub 2014 Dec 24. |
| 25823403 | Background | Yassen GH, Sabrah AH, Eckert GJ, Platt JA. Effect of different endodontic regeneration protocols on wettability, roughness, and chemical composition of surface dentin. J Endod. 2015 Jun;41(6):956-60. doi: 10.1016/j.joen.2015.02.023. Epub 2015 Mar 29. |
| 21743418 | Background | Neha K, Kansal R, Garg P, Joshi R, Garg D, Grover HS. Management of immature teeth by dentin-pulp regeneration: a recent approach. Med Oral Patol Oral Cir Bucal. 2011 Nov 1;16(7):e997-1004. doi: 10.4317/medoral.17187. |
| 21238791 | Background | Lovelace TW, Henry MA, Hargreaves KM, Diogenes A. Evaluation of the delivery of mesenchymal stem cells into the root canal space of necrotic immature teeth after clinical regenerative endodontic procedure. J Endod. 2011 Feb;37(2):133-8. doi: 10.1016/j.joen.2010.10.009. |
| 18436046 | Background | Cotti E, Mereu M, Lusso D. Regenerative treatment of an immature, traumatized tooth with apical periodontitis: report of a case. J Endod. 2008 May;34(5):611-6. doi: 10.1016/j.joen.2008.02.029. |
| 21846559 | Background | Cehreli ZC, Isbitiren B, Sara S, Erbas G. Regenerative endodontic treatment (revascularization) of immature necrotic molars medicated with calcium hydroxide: a case series. J Endod. 2011 Sep;37(9):1327-30. doi: 10.1016/j.joen.2011.05.033. Epub 2011 Jul 13. |
| 23439044 | Background | Law AS. Considerations for regeneration procedures. J Endod. 2013 Mar;39(3 Suppl):S44-56. doi: 10.1016/j.joen.2012.11.019. |
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |