RevascularizationNCT06012331
Clinical and Radiographic Evaluation of Revascularization of Immature Anterior Permanent Teeth Using Concentrated Growth Factor (CGF) Versus Blood Clot (BC)
A study testing concentrated growth factors in open apex and Blood Clot (BC) in people with Revascularization, run by Cairo University.
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 Read more about this study
- Who is it for?
- Ages 8 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Revascularization
- What is being tested?
- concentrated growth factors in open apex and Blood Clot (BC)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Jun 2024to Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- Medically compromised patient.
- Teeth with vertical fractures.
- Non-restorable teeth.
- Teeth when bleeding could not be induced.
- Unable to attend follow-up visits.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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:
- Concentrated Growth Factor
- Blood Clot
Read the 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.
- Conditions
- Revascularization
- Being tested
- concentrated growth factors in open apex, Blood Clot (BC)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
concentrated growth factors in open apexProcedure or surgery
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)Procedure or surgery
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Concentrated Growth Factor (CGF) | Experimental | 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 Receives: Procedure: concentrated growth factors in open apex; Procedure: Blood Clot (BC) |
| Blood Clot (BC) | Active comparator | 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 Receives: Procedure: concentrated growth factors in open apex; Procedure: Blood Clot (BC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3,6,9,12 months
Secondary outcomes (1)
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.
Measured: 6, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2023
- Study startJun 2024 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for RevascularizationStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hana Ahmed Omer, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06012331
- Sponsor's protocol ID
- dental pulp revascularization
- Status last verified
- Sep 2023
- First submitted
- 7 Aug 2023
- Last updated
- 6 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 6944166Ruskin 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.
PubMed 8214771
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Evaluation of Revascularization of Immature Anterior Permanent Teeth Using (CGF) Versus (BC)
- ClinicalTrials.gov ID
- NCT06012331
- Acronym / sponsor ID
- dental pulp revascularization
- Conditions
- Revascularization
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jun 2024 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 25 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to compare clinical and radiographic evaluation treatment of necrotic immature permanent teeth using:
- Concentrated Growth Factor
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Concentrated Growth Factor (CGF) | Experimental | Procedure: concentrated growth factors in open apex, Procedure: 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) | Active comparator | Procedure: concentrated growth factors in open apex, Procedure: 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 |
Who may qualify
- Ages
- 8 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- Medically compromised patient.
- Teeth with vertical fractures.
- Non-restorable teeth.
- Teeth when bleeding could not be induced.
- Unable to attend follow-up visits.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| concentrated growth factors in open apexDry 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 or surgery | Blood Clot (BC), Concentrated Growth Factor (CGF) |
| Blood Clot (BC)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. | Procedure or surgery | Blood Clot (BC), Concentrated Growth Factor (CGF) |
Primary outcome
clinically successful treatment
Time frame: 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
1 secondary outcome
Radiographic Success treatment
Time frame: 6, 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2024.
- Background: PubMed 6944166Kasprisin 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.
- Background: PubMed 8214771Ruskin 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing concentrated growth factors in open apex and Blood Clot (BC) in people with Revascularization, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hana A Omer, master (+201144587858, hana.omer@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinically successful treatment (time frame: 3,6,9,12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06012331, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2024.