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

Sponsor

Cairo University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06012331

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Concentrated Growth Factor
Blood Clot

Condition or Disease	Intervention/Treatment	Phase
Revascularization	Procedure: concentrated growth factors in open apex Procedure: Blood Clot (BC)	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Clinical and Radiographic Evaluation of Revascularization of Immature Anterior Permanent Teeth Using (CGF) Versus (BC)

Anticipated Study Start Date :

Dec 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2024

Anticipated Study Completion Date :

Jan 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	Procedure: 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 Procedure: Blood Clot (BC) 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) Stop bleeding at a level that allows for 3-4 mm of restorative material. Then white MTA as a coronal plug material be followed by GIC, then composite restoration.
Active Comparator: 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	Procedure: 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 Procedure: Blood Clot (BC) 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) Stop bleeding at a level that allows for 3-4 mm of restorative material. Then white MTA as a coronal plug material be followed by GIC, then composite restoration.

Arm

Intervention/Treatment

Experimental: Concentrated Growth Factor (CGF)

Procedure: 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

Procedure: Blood Clot (BC)

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) Stop bleeding at a level that allows for 3-4 mm of restorative material. Then white MTA as a coronal plug material be followed by GIC, then composite restoration.

Active Comparator: 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

Procedure: concentrated growth factors in open apex

Procedure: Blood Clot (BC)

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

8 Years to 14 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Children aged between 7-13 years.
Anterior tooth diagnosed with necrotic pulp (due to trauma, caries, or anomaly) responded negatively to sensibility tests.
Teeth not indicated for post and core.
A cooperative and compliant patient/parent.
Patients not allergic to medicaments necessary to complete the procedure.
Patients with no history of chronic systemic diseases.

Exclusion Criteria:

Medically compromised patient.
Teeth with vertical fractures.
Non-restorable teeth.
Teeth when bleeding could not be induced.
Unable to attend follow-up visits.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Hana Ahmed Omer, PhD researcher in pediatric dentistry and public health department, Cairo University

ClinicalTrials.gov Identifier:

NCT06012331

Other Study ID Numbers:

dental pulp revascularization

First Posted:

Aug 25, 2023

Last Update Posted:

Aug 30, 2023

Last Verified:

Aug 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Mitogens

Study Results

No Results Posted as of Aug 30, 2023