Efficacy of Combined Blood Clot and Platelet Rich Fibrin Scaffolds in Regeneration of Necrotic Immature Permanent Teeth
2020年11月2日 更新者：Nourhan M.Aly
Efficacy of Combined Blood Clot and Platelet Rich Fibrin Scaffolds in Regeneration of Necrotic Immature Permanent Teeth (A Randomized Controlled Clinical Trial)
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.
研究概览
详细说明
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.
研究类型
介入性
注册 (实际的)
30
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
-
Alexandria、埃及、21512
- Faculty of dentistry, Alexandria university
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
8年 至 18年 (孩子、成人)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Necrotic incisors with immature roots
- Pulp space not needed for post and core.
- The patient has to be free from any coagulation disorders, with normal platelets count.
- Good oral hygiene
- Cooperative patient
Exclusion Criteria:
- Internal or external root resorption.
- Root fracture and/or alveolar fracture.
- Previous root canal treatment.
- Medically compromised patients
- Uncooperative patient
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：Induced blood clot scaffold
|
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. |
|
实验性的：Induced blood clot scaffold combined with Platelet rich fibrin
|
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.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Subjective pain assessment
大体时间：1 month
|
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
大体时间：3 months
|
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
大体时间：6 months
|
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
大体时间：12 months
|
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
大体时间：1 month
|
Pulp vitality will be assessed using thermal and electric pulp sensibility tests
|
1 month
|
|
Assessment of pulp vitality
大体时间：3 months
|
Pulp vitality will be assessed using thermal and electric pulp sensibility tests
|
3 months
|
|
Assessment of pulp vitality
大体时间：6 months
|
Pulp vitality will be assessed using thermal and electric pulp sensibility tests
|
6 months
|
|
Assessment of pulp vitality
大体时间：12 months
|
Pulp vitality will be assessed using thermal and electric pulp sensibility tests
|
12 months
|
|
Assessment of root development
大体时间：1 month
|
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
大体时间：3 months
|
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
大体时间：6 months
|
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
大体时间：12 months
|
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
大体时间：1 month
|
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
大体时间：1 month
|
Size of the lesion will be assessed using Cone Beam Computed Tomography (CBCT).
|
1 month
|
|
Assessment of the size of periapical radiolucency
大体时间：3 months
|
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
大体时间：3 months
|
Size of the lesion will be assessed using Cone Beam Computed Tomography (CBCT).
|
3 months
|
|
Assessment of the size of periapical radiolucency
大体时间：6 months
|
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
大体时间：6 months
|
Size of the lesion will be assessed using Cone Beam Computed Tomography (CBCT).
|
6 months
|
|
Assessment of the size of periapical radiolucency
大体时间：12 months
|
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
大体时间：12 months
|
Size of the lesion will be assessed using Cone Beam Computed Tomography (CBCT).
|
12 months
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Mahmoud MS Hassan, M.Sc、Faculty of Dentistry, Alexandria University, Egypt
- 研究主任：Mohamed Ibrahim, PhD、Faculty of Dentistry, Alexandria University, Egypt
- 研究主任：Sybel M Moussa, PhD、Faculty of Dentistry, Alexandria University, Egypt
- 学习椅：Nihal A Lehita, PhD、Faculty of Dentistry, Alexandria University, Egypt
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Law AS. Considerations for regeneration procedures. J Endod. 2013 Mar;39(3 Suppl):S44-56. doi: 10.1016/j.joen.2012.11.019.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2018年7月6日
初级完成 (实际的)
2020年1月20日
研究完成 (实际的)
2020年8月30日
研究注册日期
首次提交
2020年5月8日
首先提交符合 QC 标准的
2020年5月14日
首次发布 (实际的)
2020年5月18日
研究记录更新
最后更新发布 (实际的)
2020年11月4日
上次提交的符合 QC 标准的更新
2020年11月2日
最后验证
2020年11月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- blood clot/ PRF & regeneration
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研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
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