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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Revascularization
• Intervention / Treatment: Procedure: concentrated growth factors in open apex; Procedure: Blood Clot (BC)

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 Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hana A Omer, master; Phone Number: +201144587858; Email: hana.omer@dentistry.cu.edu.eg
• Study Contact Backup: Name: Reem M Wahby, PhD; Phone Number: +201122788078; Email: reem.wahby@dentistry.cu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
clinically successful treatment	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	3,6,9,12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiographic Success treatment	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.	6, 12 months

Collaborators and Investigators

• Sponsor: Cairo University

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: August 7, 2023
• First Submitted That Met QC Criteria: August 19, 2023
• First Posted (Actual): August 25, 2023

Study Record Updates

• Last Update Posted (Estimated): February 6, 2024
• Last Update Submitted That Met QC Criteria: February 5, 2024
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Mitosis Modulators; Mitogens
• Other Study ID Numbers: dental pulp revascularization

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No