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

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.

Study Overview

• Status: Completed
• Conditions: Pulp Necroses
• Intervention / Treatment: Biological: Blood clot scaffold; Biological: Blood clot scaffold combined with PRF

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 2

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt, 21512
    • Faculty of Dentistry, Alexandria University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Induced blood clot scaffold	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.
Experimental: Induced blood clot scaffold combined with Platelet rich fibrin	Biological: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Nourhan M.Aly
• Collaborators: Alexandria University
• Investigators: Principal Investigator: Mahmoud MS Hassan, M.Sc, Faculty of Dentistry, Alexandria University, Egypt; Study Director: Mohamed Ibrahim, PhD, Faculty of Dentistry, Alexandria University, Egypt; Study Director: Sybel M Moussa, PhD, Faculty of Dentistry, Alexandria University, Egypt; Study Chair: Nihal A Lehita, PhD, Faculty of Dentistry, Alexandria University, Egypt

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 6, 2018
• Primary Completion (Actual): January 20, 2020
• Study Completion (Actual): August 30, 2020

Study Registration Dates

• First Submitted: May 8, 2020
• First Submitted That Met QC Criteria: May 14, 2020
• First Posted (Actual): May 18, 2020

Study Record Updates

• Last Update Posted (Actual): November 4, 2020
• Last Update Submitted That Met QC Criteria: November 2, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Open apex; Regenerative endodontics; Immature necrotic teeth
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Stomatognathic Diseases; Embolism and Thrombosis; Tooth Diseases; Dental Pulp Diseases; Necrosis; Thrombosis; Dental Pulp Necrosis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents, Local; Anti-Infective Agents; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Hormone Antagonists; Antifungal Agents; Steroid Synthesis Inhibitors; 14-alpha Demethylase Inhibitors; Cytochrome P-450 CYP2C9 Inhibitors; Clotrimazole; Miconazole
• Other Study ID Numbers: blood clot/ PRF & regeneration

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No