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

Not Applicable

Not yet recruiting

• Conditions: Revascularization
• Interventions: Procedure: concentrated growth factors in open apex; Procedure: Blood Clot (BC)

• Registration Number: NCT06012331
• Lead Sponsor: Cairo University

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.

Study Timeline

• Study First Submitted: 2023-08-07
• Study First Submitted QC: 2023-08-19
• Study First Posted: 2023-08-25
• Status Verified: 2023-09
• Last Update Submitted: 2024-02-05
• Last Update Posted: 2024-02-06
• Study Start: 2024-06
• Primary Completion: 2024-12
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Concentrated Growth Factor (CGF)	Blood Clot (BC)	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
Blood Clot (BC)	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
Blood Clot (BC)	concentrated growth factors in open apex	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
Concentrated Growth Factor (CGF)	concentrated growth factors in open apex	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

Primary Outcome Measures

Name	Time	Method
clinically successful treatment	3,6,9,12 months	The treatment will be considered to be clinically successful when. Absence of pain will record it by verbal question to patient/ parent. Absence of tenderness to percussion) will record it by percussion test (by the back of the dental mirror) Absence of swelling and fistula or sinus tract -- will record it by visual clinical examination

Secondary Outcome Measures

Name	Time	Method
Radiographic Success treatment	6, 12 months	The treatment will be considered to be Radiographic Success when.; * Root elongation (increased root length): will be assessed in mm through a radiographic x-ray system measure from cementoenamel junction to the apex.; * Root maturation: increased root dentin thickness will be assessed in mm through a radiographic x-ray system for each case and will be calculated as the difference between the outer root area and the pulp space area.; * Absence or reduce in the size of periapical radiolucency: will be assessed in mm through a radiographic x-ray system.