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

Revascularization Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06012331
• Other study ID #: dental pulp revascularization
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: October 2025

Study information

• Verified date: September 2023
• Source: Cairo University
• Contact: Hana A Omer, master
• Phone: +201144587858
• Email: hana.omer[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: October 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 14 Years

Eligibility

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.

Related Conditions & MeSH terms

• Revascularization

Intervention

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
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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