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Completed

NCT Number: NCT04390854

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

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.

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Key information

Conditions

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

Age range

8 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Faculty of Dentistry, Alexandria University

Alexandria, 21512, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Subjective pain assessment

    Time frame: 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

  2. Subjective pain assessment

    Time frame: 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. Subjective pain assessment

    Time frame: 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

  4. Subjective pain assessment

    Time frame: 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

  5. Assessment of pulp vitality

    Time frame: 1 month

    Pulp vitality will be assessed using thermal and electric pulp sensibility tests

  6. Assessment of pulp vitality

    Time frame: 3 months

    Pulp vitality will be assessed using thermal and electric pulp sensibility tests

  7. Assessment of pulp vitality

    Time frame: 6 months

    Pulp vitality will be assessed using thermal and electric pulp sensibility tests

  8. Assessment of pulp vitality

    Time frame: 12 months

    Pulp vitality will be assessed using thermal and electric pulp sensibility tests

  9. Assessment of root development

    Time frame: 1 month

    Continued root development will be assessed using cone beam computed tomography (CBCT) and compared with the contra-lateral healthy tooth

  10. Assessment of root development

    Time frame: 3 months

    Continued root development will be assessed using cone beam computed tomography (CBCT) and compared with the contra-lateral healthy tooth

  11. Assessment of root development

    Time frame: 6 months

    Continued root development will be assessed using cone beam computed tomography (CBCT) and compared with the contra-lateral healthy tooth

  12. Assessment of root development

    Time frame: 12 months

    Continued root development will be assessed using cone beam computed tomography (CBCT) and compared with the contra-lateral healthy tooth

  13. Assessment of the size of periapical radiolucency

    Time frame: 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).

  14. Assessment of the size of periapical radiolucency

    Time frame: 1 month

    Size of the lesion will be assessed using Cone Beam Computed Tomography (CBCT).

  15. Assessment of the size of periapical radiolucency

    Time frame: 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).

  16. Assessment of the size of periapical radiolucency

    Time frame: 3 months

    Size of the lesion will be assessed using Cone Beam Computed Tomography (CBCT).

  17. Assessment of the size of periapical radiolucency

    Time frame: 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).

  18. Assessment of the size of periapical radiolucency

    Time frame: 6 months

    Size of the lesion will be assessed using Cone Beam Computed Tomography (CBCT).

  19. Assessment of the size of periapical radiolucency

    Time frame: 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).

  20. Assessment of the size of periapical radiolucency

    Time frame: 12 months

    Size of the lesion will be assessed using Cone Beam Computed Tomography (CBCT).

Sponsors and collaborators

Lead sponsor

Nourhan M.Aly

Other

Collaborators

  • Alexandria University

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
May 18, 2020
Registry last updated
Nov 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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