Clinical and Radiographic Evaluation of Revascularization of Immature Anterior Permanent Teeth Using Concentrated Growth Factor (CGF) Versus Blood Clot (BC)

NCT ID: NCT06012331

Last Updated: 2024-02-06

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-30
• Study Completion Date: 2025-10-31

Brief Summary

The aim of this study is to compare clinical and radiographic evaluation treatment of necrotic immature permanent teeth using:

1. Concentrated Growth Factor

2. Blood Clot

Detailed Description

Rationale for conducting the research:

Concentrated growth factor (CGF) is relatively a new generation of platelet concentrate product, it contains more cytokines and growth factors compared with PRP and PRF also promotes the proliferation, migration, and differentiation of stem cells.

Conditions

Revascularization

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Concentrated Growth Factor (CGF)

Concentrated growth factor (CGF) is relatively a new generation of platelet concentrate product, it contains more cytokines and growth factors compared with PRP and PRF also promotes the proliferation, migration, and differentiation of stem cells

Group Type: EXPERIMENTAL

concentrated growth factors in open apex

Intervention Type: PROCEDURE

Dry canals with paper points. A 10 ml of venous blood will be collected and transferred to sterile tubes without anticoagulant solutions by a trained nurse. The tubes will be centrifuged machine using a one-step centrifugation protocol at variable rpm, after centrifugation, four layers will be obtained: the first layer at the top is serum, second layer is the fibrin buffy coat, the third layer is the liquid phase containing growth factors, The concentrated growth factor was separated from the red blood cells and serum using sterile scissors.

CGF will be packed into canal to the full working length using sterile pluggers.

The coronal level of the CGF gel is near the cervical area above cementoenamel junction and white MTA placed as capping material after CGF, then GIC and composite restoration

Blood Clot (BC)

Intervention Type: PROCEDURE

1. Create bleeding into the canal by over-instrumenting (induce by rotating a pre-curved K-file at 2 mm past the apical foramen with the goal of having the entire canal filled with blood to CEJ level)

2. Stop bleeding at a level that allows for 3-4 mm of restorative material.

3. Then white MTA as a coronal plug material be followed by GIC, then composite restoration.

Blood Clot (BC)

Inducing bleeding to facilitate healing is a common surgical procedure. The blood clot formed after hemorrhage, acts as a scaffold and rich source of growth factors, and could play an important role in tissue repair in the canal. The growth factors could stimulate differentiation, growth, and maturation of fibroblasts, odontoblasts and cementoblasts, from the immature undifferentiated mesenchymal cells in the newly formed tissue matrix

Group Type: ACTIVE_COMPARATOR

concentrated growth factors in open apex

Intervention Type: PROCEDURE

Dry canals with paper points. A 10 ml of venous blood will be collected and transferred to sterile tubes without anticoagulant solutions by a trained nurse. The tubes will be centrifuged machine using a one-step centrifugation protocol at variable rpm, after centrifugation, four layers will be obtained: the first layer at the top is serum, second layer is the fibrin buffy coat, the third layer is the liquid phase containing growth factors, The concentrated growth factor was separated from the red blood cells and serum using sterile scissors.

CGF will be packed into canal to the full working length using sterile pluggers.

The coronal level of the CGF gel is near the cervical area above cementoenamel junction and white MTA placed as capping material after CGF, then GIC and composite restoration

Blood Clot (BC)

Intervention Type: PROCEDURE

1. Create bleeding into the canal by over-instrumenting (induce by rotating a pre-curved K-file at 2 mm past the apical foramen with the goal of having the entire canal filled with blood to CEJ level)

2. Stop bleeding at a level that allows for 3-4 mm of restorative material.

3. Then white MTA as a coronal plug material be followed by GIC, then composite restoration.

Interventions

concentrated growth factors in open apex

Dry canals with paper points. A 10 ml of venous blood will be collected and transferred to sterile tubes without anticoagulant solutions by a trained nurse. The tubes will be centrifuged machine using a one-step centrifugation protocol at variable rpm, after centrifugation, four layers will be obtained: the first layer at the top is serum, second layer is the fibrin buffy coat, the third layer is the liquid phase containing growth factors, The concentrated growth factor was separated from the red blood cells and serum using sterile scissors.

CGF will be packed into canal to the full working length using sterile pluggers.

The coronal level of the CGF gel is near the cervical area above cementoenamel junction and white MTA placed as capping material after CGF, then GIC and composite restoration

Intervention Type: PROCEDURE

Blood Clot (BC)

1. Create bleeding into the canal by over-instrumenting (induce by rotating a pre-curved K-file at 2 mm past the apical foramen with the goal of having the entire canal filled with blood to CEJ level)

2. Stop bleeding at a level that allows for 3-4 mm of restorative material.

3. Then white MTA as a coronal plug material be followed by GIC, then composite restoration.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Children aged between 8_14 years.

2. Anterior tooth diagnosed with necrotic pulp (due to trauma, caries, or anomaly) responded negatively to sensibility tests.

3. Teeth not indicated for post and core.

4. A cooperative and compliant patient/parent.

5. Patients not allergic to medicaments necessary to complete the procedure.

6. Patients with no history of chronic systemic diseases.

Exclusion Criteria

1. Medically compromised patient.

2. Teeth with vertical fractures.

3. Non-restorable teeth.

4. Teeth when bleeding could not be induced.

5. Unable to attend follow-up visits.

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Hana Ahmed Omer

PhD researcher in pediatric dentistry and public health department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Hana A Omer, master

Role: CONTACT

hana.omer@dentistry.cu.edu.eg

+201144587858

Reem M Wahby, PhD

Role: CONTACT

reem.wahby@dentistry.cu.edu.eg

+201122788078

References

Kasprisin DO, Heiss R, Rausen AR. Cholelithiasis during remission of acute lymphocytic leukemia in a child. Clin Pediatr (Phila). 1981 Oct;20(10):678. No abstract available.

Reference Type: BACKGROUND

PMID: 6944166 (View on PubMed)

Ruskin KJ, Tissot M. A new method of communication between anesthesiologists. Anesthesiology. 1993 Oct;79(4):867. doi: 10.1097/00000542-199310000-00037. No abstract available.

Reference Type: BACKGROUND

PMID: 8214771 (View on PubMed)

Other Identifiers

dental pulp revascularization

Identifier Type: -

Identifier Source: org_study_id