- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07538921
Clinical & Radiographic Evaluation of Concentrated Growth Factors (CGF) With Auto Transplanted Closed Apex Teeth (CGF-AT)
Clinical & Radiographic Evaluation of Concentrated Growth Factors (CGF) With Auto Transplanted Closed Apex Teeth (A Case Series Study).
This study aims to clinically and radiographically evaluate the effect of Concentrated Growth Factors (CGF) on the outcomes of autotransplantation of closed apex teeth. Tooth autotransplantation is considered a viable treatment option for replacing missing teeth; however, its success may be influenced by factors such as periodontal healing and pulpal revascularization, especially in teeth with closed apices.
Concentrated Growth Factors (CGF), as an advanced generation of platelet concentrates, are rich in growth factors that may enhance tissue regeneration, promote healing, and improve the success rate of transplanted teeth.
In this study, patients requiring tooth autotransplantation will be treated using CGF at the recipient site. Clinical outcomes, including tooth stability, periodontal health, and presence of complications, will be assessed. Radiographic evaluation will be performed to monitor bone healing, root resorption, and periodontal ligament integrity over a defined follow-up period.
The findings of this study are expected to provide evidence regarding the potential benefits of CGF in improving the success and prognosis of autotransplanted closed apex teeth.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Tooth autotransplantation is a well-established treatment modality for replacing missing teeth, particularly in young patients. However, the success of this procedure depends on multiple biological factors, including the preservation of the periodontal ligament, prevention of root resorption, and the potential for pulpal healing. In teeth with closed apices, pulpal revascularization is limited, which may negatively affect the long-term prognosis of the transplanted tooth.
Recently, platelet concentrates have gained increasing attention in regenerative dentistry due to their ability to enhance wound healing and tissue regeneration. Concentrated Growth Factors (CGF) represent an advanced generation of autologous platelet concentrates characterized by a dense fibrin matrix rich in growth factors such as transforming growth factor-beta (TGF-β), vascular endothelial growth factor (VEGF), and platelet-derived growth factor (PDGF). These biological mediators play a critical role in angiogenesis, cell proliferation, and tissue regeneration.
The present study is designed to evaluate the clinical and radiographic outcomes of using CGF in autotransplantation of teeth with closed apices. The hypothesis is that the application of CGF at the recipient site may enhance healing, improve periodontal ligament regeneration, and reduce the incidence of complications such as inflammatory or replacement root resorption.
Eligible patients requiring tooth autotransplantation will be recruited according to predefined inclusion and exclusion criteria. The surgical procedure will be performed following standard protocols, with careful atraumatic extraction of the donor tooth and proper preparation of the recipient socket. CGF will be prepared from the patient's own blood using a standardized centrifugation protocol and applied to the recipient site prior to transplantation.
Postoperative follow-up will be conducted at specific intervals to assess both clinical and radiographic outcomes. Clinical evaluation will include parameters such as tooth mobility, periodontal probing depth, gingival condition, pain, and presence of infection or ankylosis. Radiographic assessment will include evaluation of bone healing, periodontal ligament space, root resorption (inflammatory or replacement), and periapical status.
Data will be collected and analyzed to compare outcomes and determine the effectiveness of CGF in improving the success rate of autotransplanted closed apex teeth. The results of this study may contribute to establishing evidence-based protocols for enhancing regenerative outcomes in tooth autotransplantation procedures.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ahmed Mohamed Sayed, Master Degree
- Phone Number: 01125547882
- Email: ahmed_sayed@dentistry.cu.edu.eg
Study Locations
-
-
Elmanial
-
Cairo, Elmanial, Egypt
- Faculty of oral and dental surgery cairo university
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Donor Tooth : any 3rd molar tooth with fully developed roots (confirmed radiographically) and not functionally used (semi impacted, impacted but easily to be extracted, absence of the opposing etc…) .
- Recipient Site : Recipient 1st or 2nd molar region (either upper or lower) with adequate bone volume to receive the auto transplanted tooth.
- Oral Health: Good general oral hygiene and absence of active periodontal disease.
- Systemic Health: patients with no contraindications for minor oral surgery.
Exclusion Criteria:
- Poor Oral Hygiene: Presence of uncontrolled gingivitis or periodontitis.
- Systemic Conditions: Patients with systemic diseases that may impair healing (e.g., uncontrolled diabetes, immunosuppression, bleeding disorders or bone metabolic diseases ).
- Smoking: Active smokers or tobacco users.
- Pregnancy or Lactation: Female patients who are pregnant or breastfeeding
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: CGF assisted auto transplantation
Participants in this arm will undergo autotransplantation of teeth with closed apices using a standardized surgical protocol.
Concentrated Growth Factors (CGF) will be prepared from the patient's own blood and applied to the recipient site prior to placement of the donor tooth.
The transplanted tooth will then be stabilized using an appropriate splinting technique.
Patients will be followed up clinically and radiographically to assess healing outcomes and treatment success.
|
In this study, autotransplantation of teeth with closed apices will be performed following standard surgical protocols. The donor tooth will be atraumatically extracted with maximum preservation of the periodontal ligament, and the recipient socket will be carefully prepared to receive the transplanted tooth. In the intervention group, Concentrated Growth Factors (CGF) will be prepared from the patient's venous blood using a standardized centrifugation protocol. The obtained CGF will be applied to the recipient socket prior to placement of the donor tooth to enhance healing and promote tissue regeneration. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in Radiographic Bone Density at the Recipient Site
Time Frame: 6 months
|
Radiographic assessment of bone density at the recipient site will be performed using CBCT imaging to evaluate bone healing over time.
|
6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Abdelmoez Mohamed El-Sharkawy, Associate Professor, Cairo University
- Study Chair: Nesrine Mohammed Khairy, Professor of OMFS, Cairo University
- Principal Investigator: Ahmed Mohamed Sayed, master degree, Cairo University
Publications and helpful links
General Publications
- Keranmu D, Ainiwaer A, Nuermuhanmode N, Ling W. Application of concentrated growth factor to autotransplantation with inflammation in recipient area. BMC Oral Health. 2021 Oct 30;21(1):556. doi: 10.1186/s12903-021-01915-3.
- Czochrowska EM, Stenvik A, Bjercke B, Zachrisson BU. Outcome of tooth transplantation: survival and success rates 17-41 years posttreatment. Am J Orthod Dentofacial Orthop. 2002 Feb;121(2):110-9; quiz 193. doi: 10.1067/mod.2002.119979.
- Chen J, Wan Y, Lin Y, Jiang H. Considerations for Clinical Use of Concentrated Growth Factor in Maxillofacial Regenerative Medicine. J Craniofac Surg. 2021 Jun 1;32(4):1316-1321. doi: 10.1097/SCS.0000000000007182.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- CU-OMFS-CGF-AT-01-2026
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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