Clinical and Radiographic Evaluation of Revascularization of Immature Anterior Permanent Teeth Using Concentrated Growth Factor (CGF) Versus Blood Clot (BC)
1 other identifier
interventional
50
0 countries
N/A
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2024
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 7, 2023
CompletedFirst Posted
Study publicly available on registry
August 25, 2023
CompletedStudy Start
First participant enrolled
June 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2025
CompletedFebruary 6, 2024
September 1, 2023
6 months
August 7, 2023
February 5, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Radiographic Success treatment
6, 12 months
Study Arms (2)
Concentrated Growth Factor (CGF)
EXPERIMENTALConcentrated 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)
ACTIVE COMPARATORInducing 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
Interventions
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
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.
Eligibility Criteria
You may qualify if:
- Children aged between 8\_14 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.
You may not qualify if:
- Medically compromised patient.
- Teeth with vertical fractures.
- Non-restorable teeth.
- Teeth when bleeding could not be induced.
- Unable to attend follow-up visits.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Related 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.
PMID: 6944166BACKGROUNDRuskin 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.
PMID: 8214771BACKGROUND
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD researcher in pediatric dentistry and public health department
Study Record Dates
First Submitted
August 7, 2023
First Posted
August 25, 2023
Study Start
June 1, 2024
Primary Completion
December 1, 2024
Study Completion
October 1, 2025
Last Updated
February 6, 2024
Record last verified: 2023-09