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Efficacy of Combined Blood Clot and Platelet Rich Fibrin Scaffolds in Regeneration of Necrotic Immature Permanent Teeth

Primary Purpose

Pulp Necroses

Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Blood clot scaffold
Blood clot scaffold combined with PRF
Sponsored by
Nourhan M.Aly
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulp Necroses focused on measuring Regenerative endodontics, Open apex, Immature necrotic teeth

Eligibility Criteria

8 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Faculty of Dentistry, Alexandria University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Induced blood clot scaffold

Induced blood clot scaffold combined with Platelet rich fibrin

Arm Description

Outcomes

Primary Outcome Measures

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
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
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
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
Assessment of pulp vitality
Pulp vitality will be assessed using thermal and electric pulp sensibility tests
Assessment of pulp vitality
Pulp vitality will be assessed using thermal and electric pulp sensibility tests
Assessment of pulp vitality
Pulp vitality will be assessed using thermal and electric pulp sensibility tests
Assessment of pulp vitality
Pulp vitality will be assessed using thermal and electric pulp sensibility tests
Assessment of root development
Continued root development will be assessed using cone beam computed tomography (CBCT) and compared with the contra-lateral healthy tooth
Assessment of root development
Continued root development will be assessed using cone beam computed tomography (CBCT) and compared with the contra-lateral healthy tooth
Assessment of root development
Continued root development will be assessed using cone beam computed tomography (CBCT) and compared with the contra-lateral healthy tooth
Assessment of root development
Continued root development will be assessed using cone beam computed tomography (CBCT) and compared with the contra-lateral healthy tooth
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).
Assessment of the size of periapical radiolucency
Size of the lesion will be assessed using Cone Beam Computed Tomography (CBCT).
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).
Assessment of the size of periapical radiolucency
Size of the lesion will be assessed using Cone Beam Computed Tomography (CBCT).
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).
Assessment of the size of periapical radiolucency
Size of the lesion will be assessed using Cone Beam Computed Tomography (CBCT).
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).
Assessment of the size of periapical radiolucency
Size of the lesion will be assessed using Cone Beam Computed Tomography (CBCT).

Secondary Outcome Measures

Full Information

First Posted
May 8, 2020
Last Updated
November 2, 2020
Sponsor
Nourhan M.Aly
Collaborators
Alexandria University
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1. Study Identification

Unique Protocol Identification Number
NCT04390854
Brief Title
Efficacy of Combined Blood Clot and Platelet Rich Fibrin Scaffolds in Regeneration of Necrotic Immature Permanent Teeth
Official Title
Efficacy of Combined Blood Clot and Platelet Rich Fibrin Scaffolds in Regeneration of Necrotic Immature Permanent Teeth (A Randomized Controlled Clinical Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
July 6, 2018 (Actual)
Primary Completion Date
January 20, 2020 (Actual)
Study Completion Date
August 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Nourhan M.Aly
Collaborators
Alexandria University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulp Necroses
Keywords
Regenerative endodontics, Open apex, Immature necrotic teeth

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
The radiographic specialist and the statistician will be blinded to treatment group
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Induced blood clot scaffold
Arm Type
Active Comparator
Arm Title
Induced blood clot scaffold combined with Platelet rich fibrin
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Blood clot scaffold
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
Blood clot scaffold combined with PRF
Intervention Description
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.
Primary Outcome Measure Information:
Title
Subjective pain assessment
Description
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
Time Frame
1 month
Title
Subjective pain assessment
Description
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
Time Frame
3 months
Title
Subjective pain assessment
Description
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
Time Frame
6 months
Title
Subjective pain assessment
Description
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
Time Frame
12 months
Title
Assessment of pulp vitality
Description
Pulp vitality will be assessed using thermal and electric pulp sensibility tests
Time Frame
1 month
Title
Assessment of pulp vitality
Description
Pulp vitality will be assessed using thermal and electric pulp sensibility tests
Time Frame
3 months
Title
Assessment of pulp vitality
Description
Pulp vitality will be assessed using thermal and electric pulp sensibility tests
Time Frame
6 months
Title
Assessment of pulp vitality
Description
Pulp vitality will be assessed using thermal and electric pulp sensibility tests
Time Frame
12 months
Title
Assessment of root development
Description
Continued root development will be assessed using cone beam computed tomography (CBCT) and compared with the contra-lateral healthy tooth
Time Frame
1 month
Title
Assessment of root development
Description
Continued root development will be assessed using cone beam computed tomography (CBCT) and compared with the contra-lateral healthy tooth
Time Frame
3 months
Title
Assessment of root development
Description
Continued root development will be assessed using cone beam computed tomography (CBCT) and compared with the contra-lateral healthy tooth
Time Frame
6 months
Title
Assessment of root development
Description
Continued root development will be assessed using cone beam computed tomography (CBCT) and compared with the contra-lateral healthy tooth
Time Frame
12 months
Title
Assessment of the size of periapical radiolucency
Description
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).
Time Frame
1 month
Title
Assessment of the size of periapical radiolucency
Description
Size of the lesion will be assessed using Cone Beam Computed Tomography (CBCT).
Time Frame
1 month
Title
Assessment of the size of periapical radiolucency
Description
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).
Time Frame
3 months
Title
Assessment of the size of periapical radiolucency
Description
Size of the lesion will be assessed using Cone Beam Computed Tomography (CBCT).
Time Frame
3 months
Title
Assessment of the size of periapical radiolucency
Description
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).
Time Frame
6 months
Title
Assessment of the size of periapical radiolucency
Description
Size of the lesion will be assessed using Cone Beam Computed Tomography (CBCT).
Time Frame
6 months
Title
Assessment of the size of periapical radiolucency
Description
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).
Time Frame
12 months
Title
Assessment of the size of periapical radiolucency
Description
Size of the lesion will be assessed using Cone Beam Computed Tomography (CBCT).
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mahmoud MS Hassan, M.Sc
Organizational Affiliation
Faculty of Dentistry, Alexandria University, Egypt
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mohamed Ibrahim, PhD
Organizational Affiliation
Faculty of Dentistry, Alexandria University, Egypt
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Sybel M Moussa, PhD
Organizational Affiliation
Faculty of Dentistry, Alexandria University, Egypt
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Nihal A Lehita, PhD
Organizational Affiliation
Faculty of Dentistry, Alexandria University, Egypt
Official's Role
Study Chair
Facility Information:
Facility Name
Faculty of Dentistry, Alexandria University
City
Alexandria
ZIP/Postal Code
21512
Country
Egypt

12. IPD Sharing Statement

Citations:
PubMed Identifier
25219066
Citation
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.
Results Reference
background
PubMed Identifier
23581794
Citation
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.
Results Reference
background
PubMed Identifier
25984471
Citation
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.
Results Reference
background
PubMed Identifier
25823403
Citation
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.
Results Reference
background
PubMed Identifier
21743418
Citation
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.
Results Reference
background
PubMed Identifier
21238791
Citation
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.
Results Reference
background
PubMed Identifier
18436046
Citation
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.
Results Reference
background
PubMed Identifier
21846559
Citation
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.
Results Reference
background
PubMed Identifier
23439044
Citation
Law AS. Considerations for regeneration procedures. J Endod. 2013 Mar;39(3 Suppl):S44-56. doi: 10.1016/j.joen.2012.11.019.
Results Reference
background

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Efficacy of Combined Blood Clot and Platelet Rich Fibrin Scaffolds in Regeneration of Necrotic Immature Permanent Teeth

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