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The goal of this clinial trial is to detect Which one of two different platelet concentrate bio-membrane (first or third generation) is better in terms of marginal bone level and bone density around immediate implants in esthetic zone using Cone beam computerized tomography The plasma rich in growth factor or concentrated growth factor?
20 patients with nonrestorable maxillary tooth in the esthetic zone, Subjects will be enrolled
The study will use simple randomization to allocate patients into 2 groups, each group will be included 10 patients: Group A: (concentrated growth factor group) ten patients indicated for immediate implant in the maxillary anterior region (class II socket), will be a candidate for immediate implant placement with CGF combined with xenogeneic bone graft Group B: (platelet-rich in growth factor group) Ten patients who indicated immediate implant in the maxillary anterior region (class I or class II socket), will be a candidate for immediate implant placement with PRGF combined with xenogeneic bone graft.
with the increasing practice of dental implants; the esthetic outcome is considered as important as the functional and biological outcome Immediate implants have been evolved as the first treatment option in cases of the failed tooth to decrease the time of treatment plan To obtain an effective esthetic outcome with a single implant-supported restoration in the anterior region, it is crucial to preserve and maintain intact the bone anatomy
Numerous studies have explored the suitability of biocompatible materials in regenerative medicine. Platelet concentrates are originated from centrifuged blood and are named according to their biological characteristics, such as platelet-rich plasma, platelet-rich fibrin, and concentrated growth factor
Plasma rich in growth factors (PRGF), a subtype of P-PRP (pure platelet-rich plasma), is a supernatant enriched in plasma and platelet-derived morphogens, proteins, and growth factors. PRGF represents a complex pool of active mediators that may stimulate and accelerate tissue regeneration, which is generally safe to use and economical to obtain. Autologous PRGF has been approved for clinical use by the European Community and the U.S. Food and Drug Administration
CGF (concentrated growth factor), the third-generation platelet concentrate presented by Sacco in 2006 carries more growth factors and has a firmer fibrin structure than first-generation PRP and second-generation PRF (platelet-rich fibrin)
Aim of the study is
20 patients with nonrestorable maxillary tooth in the esthetic zone, Subjects will be enrolled
The study will use simple randomization to allocate patients into 2 groups, each group will be included 10 patients: Group A: (concentrated growth factor group) ten patients indicated for immediate implant in the maxillary anterior region (class II socket), will be a candidate for immediate implant placement with CGF combined with xenogeneic bone graft Group B: (platelet-rich in growth factor group) Ten patients who indicated immediate implant in the maxillary anterior region (class I or class II socket), will be a candidate for immediate implant placement with PRGF combined with xenogeneic bone graft.
Protocol for CGF preparation:
10 ml venous blood samples will be drawn from the patients and placed in a centrifuge tube without anticoagulants. Then the tubes will be placed in the centrifugation device in an opposing balanced manner and rotated in four sequential steps. The first step at 735 g (2249 ≈ 2200) for 2 min., the second one at 580 g (1998 ≈ 2000) for 4 min., the third one at 735 g (2249 ≈ 2200) for 4 min. and the fourth one at 905 g (2495 ≈ 2500) for 3 min. The result was a clot that was collected using a straight tweezer and ready to be used
Protocol for PRGF preparation:
30 ml venous blood will be collected from the patient then deposited in 5 mL tubes containing sodium citrate anticoagulant. Then the tubes will be centrifuged at 580 G (2270 rpm) for 8 minutes at room temperature. After centrifugation, the blood sample will be layered into the following four distinctive layers:
Surgical Phase
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group A (Concentrated Growth Factor) CGF | Active Comparator | ten patients indicated for immediate implant in the maxillary anterior region (class II socket) |
|
| group B (Plasma Rich in Growth Factor) PRGF | Active Comparator | Ten patients who indicated immediate implant in the maxillary anterior region (class I or class II socket), |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Drug: Growth Factors (CGF) | Drug | Application of biological membrane of Concentrated growth factor (CGF) over bone grafting and implant |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bone Density | evaluation of bone density around immediate implants as (D1,D2,D3,D4) | 9 months |
| Marginal Bone Level. | evaluation of marginal bone level around implant in comparison with baseline bone level immediately after surgery using a fixed point on CBCT | 9 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ahmed a khalil, PhD | oral medicine and periodontology department faculty of dentistry minia university | Study Director |
| Ahmed a Mustafa, PhD | oral medicine and periodontology department faculty of dentistry minia university | Study Director |
| hussein f mohammad, bachelor | oral medicine and periodontology department faculty of dentistry minia university | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dentistry Minia University | Minya | 61519 | Egypt |
age medical history oral hygiene status
after study completion and for 3 years
investigators related to official organization
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| ID | Title | Description |
|---|---|---|
| FG000 | Group A (Concentrated Growth Factor) CGF | ten patients indicated for immediate implant in the maxillary anterior region (class II socket) Drug: Growth Factors (CGF): Application of biological membrane of Concentrated growth factor (CGF) over bone grafting and implant Surgery: Dental Implant surgery: Immediate implant following extraction Tooth extraction: A Traumatic tooth extraction Xenogenic bone grafting: Application of bovine bone grafting over area of dehiscence around immediate implant |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 30, 2022 |
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The study will use simple randomization to allocate patients into 2 groups, each group will be included 10 patients.
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|
| Drug: Growth Factors (PRGF) | Drug | Application of biological membrane of Plasma rich in growth factors combined with Xenogeneic bone grafting material around immediate implant |
|
|
| Surgery: Dental Implant surgery | Procedure | Immediate implant following extraction |
|
| Tooth extraction | Procedure | A Traumatic tooth extraction |
|
| Xenogenic bone grafting | Procedure | Application of bovine bone grafting over area of dehiscence around immediate implant |
|
| FG001 | Group B (Plasma Rich in Growth Factor) PRGF | Ten patients who indicated immediate implant in the maxillary anterior region (class I or class II socket), Drug: Growth Factors (PRGF): Application of biological membrane of Plasma rich in growth factors combined with Xenogeneic bone grafting material around immediate implant Surgery: Dental Implant surgery: Immediate implant following extraction Tooth extraction: A Traumatic tooth extraction |
| COMPLETED |
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| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group A (Concentrated Growth Factor) CGF | Ten patients indicated for immediate implant in the maxillary anterior region (class II socket) Drug: Growth Factors (CGF): Application of biological membrane of Concentrated growth factor (CGF) over bone grafting and implant Surgery: Dental Implant surgery: Immediate implant following extraction Tooth extraction: A Traumatic tooth extraction Xenogenic bone grafting: Application of bovine bone grafting over area of dehiscence around immediate implant |
| BG001 | Group B (Plasma Rich in Growth Factor) PRGF | Ten patients who indicated immediate implant in the maxillary anterior region (class I or class II socket), Drug: Growth Factors (PRGF): Application of biological membrane of Plasma rich in growth factors combined with Xenogeneic bone grafting material around immediate implant Surgery: Dental Implant surgery: Immediate implant following extraction Tooth extraction: A Traumatic tooth extraction |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Bone Density | Mean | Standard Deviation | Hounsfield |
| |||||||||||||||
| Marginal bone level | Mean | Standard Deviation | millimeter |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Bone Density | evaluation of bone density around immediate implants as (D1,D2,D3,D4) | Posted | Mean | Standard Deviation | Hounsfield | 9 months |
|
|
| |||||||||||||||||||||||||||||
| Primary | Marginal Bone Level. | evaluation of marginal bone level around implant in comparison with baseline bone level immediately after surgery using a fixed point on CBCT | Posted | Mean | Standard Deviation | millimeter | 9 months |
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|
9 months
the surgery was done under local anasthesia, senstivity test was done preoperatively patients were subjected to detailed history taking to assure excluding of patients with present illness or immunocompromised status all steps were done in hospital
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group A (Concentrated Growth Factor) CGF | ten patients indicated for immediate implant in the maxillary anterior region (class II socket) Drug: Growth Factors (CGF): Application of biological membrane of Concentrated growth factor (CGF) over bone grafting and implant Surgery: Dental Implant surgery: Immediate implant following extraction Tooth extraction: A Traumatic tooth extraction Xenogenic bone grafting: Application of bovine bone grafting over area of dehiscence around immediate implant | 0 | 10 | 0 | 10 | 0 | 10 |
| EG001 | Group B (Plasma Rich in Growth Factor) PRGF | Ten patients who indicated immediate implant in the maxillary anterior region (class I or class II socket), Drug: Growth Factors (PRGF): Application of biological membrane of Plasma rich in growth factors combined with Xenogeneic bone grafting material around immediate implant Surgery: Dental Implant surgery: Immediate implant following extraction Tooth extraction: A Traumatic tooth extraction | 0 | 10 | 0 | 10 | 1 | 10 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| hemorrhage | Blood and lymphatic system disorders | Non-systematic Assessment | hemorrhage due to affection of blood vessels during implant surgery |
| |
| Nerve damage | Nervous system disorders | Non-systematic Assessment | encroachment of ASA or MSA nerves during the surgery |
| |
| violation of maxillary sinus | Surgical and medical procedures | Non-systematic Assessment | violation of maxillary sinus wall and schneiderian membrane during implantation |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| postoperative bleeding | Blood and lymphatic system disorders | Non-systematic Assessment | postoperative bleeding from the site of implant |
| |
| postoperative swelling | Surgical and medical procedures | Non-systematic Assessment | delayed edema after the surgical procedures |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| DR. Hussein fathy | Minia university, faculty of dentistry | +201092452350 | hussein.fathy@mu.edu.eg |
| Apr 26, 2024 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D036341 | Intercellular Signaling Peptides and Proteins |
| D014081 | Tooth Extraction |
| ID | Term |
|---|---|
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D019647 | Oral Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D003813 | Dentistry |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Participants |
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