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

Pulp Necroses Clinical Trial

Official title:

Efficacy of Combined Blood Clot and Platelet Rich Fibrin Scaffolds in Regeneration of Necrotic Immature Permanent Teeth (A Randomized Controlled Clinical Trial)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04390854
• Other study ID #: blood clot/ PRF & regeneration
• Status: Completed
• Phase: Phase 2
• Start date: July 6, 2018
• Est. completion date: August 30, 2020

Study information

• Verified date: November 2020
• Source: University of Alexandria
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 30, 2020
• Est. primary completion date: January 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Dental Pulp Necrosis
• Necrosis
• Pulp Necroses
• Thrombosis

Intervention

Biological:
• 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.
• Blood clot scaffold combined with PRF
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.

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry, Alexandria University	Alexandria

Sponsors (2)

Lead Sponsor	Collaborator
Nourhan M.Aly	Alexandria University

Country where clinical trial is conducted

Egypt, 

References & Publications (9)

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. — View 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. — View 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. — View 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. — View Citation

Law AS. Considerations for regeneration procedures. J Endod. 2013 Mar;39(3 Suppl):S44-56. doi: 10.1016/j.joen.2012.11.019. Review. — View 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. — View 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. Review. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Assessment of pulp vitality	Pulp vitality will be assessed using thermal and electric pulp sensibility tests	1 month
Primary	Assessment of pulp vitality	Pulp vitality will be assessed using thermal and electric pulp sensibility tests	3 months
Primary	Assessment of pulp vitality	Pulp vitality will be assessed using thermal and electric pulp sensibility tests	6 months
Primary	Assessment of pulp vitality	Pulp vitality will be assessed using thermal and electric pulp sensibility tests	12 months
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Assessment of the size of periapical radiolucency	Size of the lesion will be assessed using Cone Beam Computed Tomography (CBCT).	1 month
Primary	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
Primary	Assessment of the size of periapical radiolucency	Size of the lesion will be assessed using Cone Beam Computed Tomography (CBCT).	3 months
Primary	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
Primary	Assessment of the size of periapical radiolucency	Size of the lesion will be assessed using Cone Beam Computed Tomography (CBCT).	6 months
Primary	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
Primary	Assessment of the size of periapical radiolucency	Size of the lesion will be assessed using Cone Beam Computed Tomography (CBCT).	12 months