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

NCT04390854 | Completed Phase 2

• 1 other identifier: blood clot/ PRF & regeneration
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulp Necroses

Keywords

Regenerative endodontics; Open apex; Immature necrotic teeth

Outcome Measures

Primary Outcomes (20)

• 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

Study Arms (2)

Induced blood clot scaffold

ACTIVE COMPARATOR

Biological: Blood clot scaffold

Induced blood clot scaffold combined with Platelet rich fibrin

EXPERIMENTAL

Biological: Blood clot scaffold combined with PRF

Interventions

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.

Induced blood clot scaffold

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.

Induced blood clot scaffold combined with Platelet rich fibrin

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Internal or external root resorption.
• Root fracture and/or alveolar fracture.
• Previous root canal treatment.
• Medically compromised patients
• Uncooperative patient

Sponsors & Collaborators

• Nourhan M.Aly: lead
• Alexandria University: collaborator

Study Sites (1)

Faculty of Dentistry, Alexandria University

Alexandria, 21512, Egypt

Location

Related 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.

  PMID: 25219066 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.

  PMID: 23581794 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.

  PMID: 25984471 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.

  PMID: 25823403 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.

  PMID: 21743418 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.

  PMID: 21238791 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.

  PMID: 18436046 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.

  PMID: 21846559 BACKGROUND

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

  PMID: 23439044 BACKGROUND

MeSH Terms

Conditions

Dental Pulp Necrosis

Interventions

Prolactin-Releasing Hormone

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The radiographic specialist and the statistician will be blinded to treatment group
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Teaching Assistant of Dental Public Health and Statistician

Study Record Dates

• First Submitted: May 8, 2020
• First Posted: May 18, 2020
• Study Start: July 6, 2018
• Primary Completion: January 20, 2020
• Study Completion: August 30, 2020
• Last Updated: November 4, 2020

Record last verified: 2020-11

Locations

EG (1)