Odontogenic Maxillary CystsPhase 4NCT03003013
Effect of Biphasic Bone Graft Material With Autologous Platelet-rich Fibrin on Bone Regeneration in a Maxillary Cyst
A Phase 4 study testing Biphasic Bone Graft Material (BGM) in Combination With Autologous Platelet-rich Fibrin (PRF) in people with Odontogenic Maxillary Cysts, run by Cairo University at 1 site in Egypt.
Trial summary
Effect of Biphasic Bone Graft Material (BGM) in combination with autologous platelet-rich fibrin (PRF) on bone regeneration in an odontogenic maxillary cyst: a randomized clinical trial Read more about this study
- Who is it for?
- Ages 15 to 60 years
- Conditions the study is for
- Odontogenic Maxillary Cysts
- What is being tested?
- Biphasic Bone Graft Material (BGM) in Combination With Autologous Platelet-rich Fibrin (PRF)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteEgypt
- Study dates
- Nov 2016to Dec 2018
- Phase
- Phase 4
- 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 15 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age range is 15: 60 years old.
- A maxillary odontogenic cysts larger than 3 cm in size.
Who cannot join
- A maxillary odontogenic cysts smaller than 3 cm in size.
- A mandibular odontogenic cysts.
- Non odontogenic cysts.
- Patients with thrombotic risk factors or taking anti-platelets drugs.
- Patients with systemic diseases
- -
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Oral & Dental Medicine Cairo University
Cairo
Sherif AbdelMonem Abdel Aziz, BDS, (+002)01009026713, dr_sherifelsaraf@yahoo.com
About this study
Official title: Effect of Biphasic Bone Graft Material (BGM) in Combination With Autologous Platelet-rich Fibrin (PRF) on Bone Regeneration in an Odontogenic Maxillary Cyst: a Randomized Clinical Trial
Effect of Biphasic Bone Graft Material (BGM) in combination with autologous platelet-rich fibrin (PRF) on bone regeneration in an odontogenic maxillary cyst: a randomized clinical trial
Read the detailed description
Odontogenic cysts are the most common form of cystic lesions that affect the oral and maxillofacial region. Their origin, mechanism of growth, as well as treatment problems have been often discussed.
Platelet rich fibrin (PRF) is a second generation platelet concentrate first developed in France by Choukron et al in 2001, prepared from centrifuged autologous blood. It is a fibrin clot rich in platelets without addition of bovine thrombin, calcium chloride or anticoagulant during preparation thus eliminating the risks associated with the use of thrombin. Platelet rich fibrin is derived from a natural and progressive polymerization occurring centrifugation. A progressive or relatively slow polymerization mode may increase incorporation of the circulating cytokines in the fibrin meshes which are then released in a relatively long-term and controllable way which in turn will help in soft tissue healing and accelerated bone regeneration.
Blood Derivatives Enhancing Bone Regeneration:
1-Fibrin glue: It is classically described as a two component mixture in which concentrated fibrinogen factor XIII and fibronectin are added to thrombin ,calcium choloride and an inhibitor of fibrinolysis to form a fibrin clot .
Shortcomings:
The risk of transmission of virus, like human immunodeficiency virus (HIV). 2. Autologous Fibrin Adhesives: The patient's blood is harvested 1:3 weeks before the intervention and requires separating one unit of whole blood cell component and plasma fraction for use as cryoprecipitate.
Shortcomings:
- Extremely long.
- Complex protocols. 3. Platelet rich plasma (PRP): It is a modification type of autologous fibrin adhesives which requires autologous blood collection in the immediate preoperative period and processing in the centrifugation which is then mixed with bovine thrombine and calcium chloride at the time of application.
Shortcomings:
- The use of bovine thrombin puts the patient at risk of life -threating coagulopathies associated with the development of antibodies to factor V , XI and thrombin .
- Higher concentration of thrombin impedes cell migration during bone healing.
- It mediates only the early aspects of bone repair. A variety of treatment modalities including the use of autogenous bone grafts and bone substitutes materials ,guided tissue regeneration (GTR) with the use of barrier membranes and growth factors have been used to stimulate bone regeneration mechanism.The drawbacks associated with autogenous bone grafts have led to the production of a large number of alternative bone substitute materials. Their biological behavior depends upon their chemical composition and physicochemical structure. Bone grafting materials include autografts, allografts, xenografts and alloplasts. The osteoconductive hydroxyapatite grafting materials have been widely used to enhance new bone regeneration.
SYMBIOS®:
Biphasic Bone Graft Material (BGM) is a resorbable inorganic bone forming material in granular form of plant origin derived from red marine algae. The chemical composition of this interconnected porous biological product is similar to the inorganic part of the human bone. It is a composition of 20% hydroxyapatite (HA) and 80% β-tricalciumphosphate (ß-TCP). Due to the high tricalcium- phosphate content of the product it resorbs significantly faster than pure hydroxyapatite. The biphasic BGM is biocompatible and osteoconductive. The selection of the two grain sizes is dependent on the defect.
Growth factors represent an area of interest for surgeons attempting to modify and enhance the wound healing process and tissue regeneration. However, the Platelet-Rich Plasma (PRP) is already in use for some time by hematologists for transfusions and prevention of bleeding episodes in patients with severe thrombocytopenia.
Uses of PRF Over PRP:
- The improved mechanical properties of PRF over conventional PRP translate it into a biologic matrix that is easy to handle and implant in awide variety of tissue repair applications.
- Platelets rich fibrin has increased modulus of elasticity. This property imparts it better pliability and drapability, allowing it to closely conform to awide variety of irregular surgical sites and surfaces similar to split thickness skin auto grafts.
- Platelet rich fibrin can easily be sutured to surgical site.
Benefits of this study to patients:
- Treatment of cystic lesions.
- Enhancement of bone regeneration.
Benefits of this study for other clinicians:
The study provides a new modality for the regeneration of new bone after cystic enucleation.
- Conditions
- Odontogenic Maxillary Cysts
- Being tested
- Biphasic Bone Graft Material (BGM) in Combination With Autologous Platelet-rich Fibrin (PRF)
- Keywords
- Odontogenic cysts, Bone substitutes materials, SYMBIOS®, Platelets rich fibrin (PRF), Bone regeneration
- Medical subject headings
- Odontogenic Cysts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biphasic Bone Graft Material (BGM) in Combination With Autologous Platelet-rich Fibrin (PRF)Procedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Biphasic Bone Graft With Autologous Platelet-rich Fibrin | Active comparator | Patients will undergo complete removal of the cystic cavity with the application of SYMBIOS biphasic bone graft material in combination with PRF in the cystic cavity Receives: Procedure: Biphasic Bone Graft Material (BGM) in Combination With Autologous Platelet-rich Fibrin (PRF) |
| Biphasic Bone Graft Material only | Active comparator | Patients will undergo complete removal of the cystic cavity with the application of SYMBIOS biphasic bone graft material without PRF in the cystic cavity Receives: Procedure: Biphasic Bone Graft Material (BGM) in Combination With Autologous Platelet-rich Fibrin (PRF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Swelling
Visual analogue scale
Measured: six weeks
Secondary outcomes (1)
bone regeneration
Gray scale value via cone beam CT
Measured: from six to nine months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2016 (estimated)
- Study startNov 2016
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Odontogenic Maxillary CystsStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sherif Abdel Monem Abdel Aziz, Cairo University
- Investigators
- Niven Abal Latif Askar, PhD, Study director, Assistant Professor of Oral& Maxillofacial Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03003013
- Sponsor's protocol ID
- CU
- Status last verified
- Jul 2018
- First submitted
- 16 Nov 2016
- Last updated
- 17 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Biphasic Bone Graft Material (BGM) in Combination With Autologous Platelet-rich Fibrin (PRF) on Bone Regeneration in an Odontogenic Maxillary Cyst: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03003013
- Acronym / sponsor ID
- CU
- Conditions
- Odontogenic Maxillary Cysts
- Keywords
- Odontogenic cysts, Bone substitutes materials, SYMBIOS®, Platelets rich fibrin (PRF), Bone regeneration
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Nov 2016 (actual)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 26 Dec 2016 (estimated)
- 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.
Effect of Biphasic Bone Graft Material (BGM) in combination with autologous platelet-rich fibrin (PRF) on bone regeneration in an odontogenic maxillary cyst: a randomized clinical trial
Detailed description
Odontogenic cysts are the most common form of cystic lesions that affect the oral and maxillofacial region. Their origin, mechanism of growth, as well as treatment problems have been often discussed.
Platelet rich fibrin (PRF) is a second generation platelet concentrate first developed in France by Choukron et al in 2001, prepared from centrifuged autologous blood. It is a fibrin clot rich in platelets without addition of bovine thrombin, calcium chloride or anticoagulant during preparation thus eliminating the risks associated with the use of thrombin. Platelet rich fibrin is derived from a natural and progressive polymerization occurring centrifugation. A progressive or relatively slow polymerization mode may increase incorporation of the circulating cytokines in the fibrin meshes which are then released in a relatively long-term and controllable way which in turn will help in soft tissue healing and accelerated bone regeneration.
Blood Derivatives Enhancing Bone Regeneration:
1-Fibrin glue: It is classically described as a two component mixture in which concentrated fibrinogen factor XIII and fibronectin are added to thrombin ,calcium choloride and an inhibitor of fibrinolysis to form a fibrin clot .
Shortcomings:
The risk of transmission of virus, like human immunodeficiency virus (HIV). 2. Autologous Fibrin Adhesives: The patient's blood is harvested 1:3 weeks before the intervention and requires separating one unit of whole blood cell component and plasma fraction for use as cryoprecipitate.
Shortcomings:
- Extremely long.
- Complex protocols. 3. Platelet rich plasma (PRP): It is a modification type of autologous fibrin adhesives which requires autologous blood collection in the immediate preoperative period and processing in the centrifugation which is then mixed with bovine thrombine and calcium chloride at the time of application.
Shortcomings:
- The use of bovine thrombin puts the patient at risk of life -threating coagulopathies associated with the development of antibodies to factor V , XI and thrombin .
- Higher concentration of thrombin impedes cell migration during bone healing.
- It mediates only the early aspects of bone repair. A variety of treatment modalities including the use of autogenous bone grafts and bone substitutes materials ,guided tissue regeneration (GTR) with the use of barrier membranes and growth factors have been used to stimulate bone regeneration mechanism.The drawbacks associated with autogenous bone grafts have led to the production of a large number of alternative bone substitute materials. Their biological behavior depends upon their chemical composition and physicochemical structure. Bone grafting materials include autografts, allografts, xenografts and alloplasts. The osteoconductive hydroxyapatite grafting materials have been widely used to enhance new bone regeneration.
SYMBIOS®:
Biphasic Bone Graft Material (BGM) is a resorbable inorganic bone forming material in granular form of plant origin derived from red marine algae. The chemical composition of this interconnected porous biological product is similar to the inorganic part of the human bone. It is a composition of 20% hydroxyapatite (HA) and 80% β-tricalciumphosphate (ß-TCP). Due to the high tricalcium- phosphate content of the product it resorbs significantly faster than pure hydroxyapatite. The biphasic BGM is biocompatible and osteoconductive. The selection of the two grain sizes is dependent on the defect.
Growth factors represent an area of interest for surgeons attempting to modify and enhance the wound healing process and tissue regeneration. However, the Platelet-Rich Plasma (PRP) is already in use for some time by hematologists for transfusions and prevention of bleeding episodes in patients with severe thrombocytopenia.
Uses of PRF Over PRP:
- The improved mechanical properties of PRF over conventional PRP translate it into a biologic matrix that is easy to handle and implant in awide variety of tissue repair applications.
- Platelets rich fibrin has increased modulus of elasticity. This property imparts it better pliability and drapability, allowing it to closely conform to awide variety of irregular surgical sites and surfaces similar to split thickness skin auto grafts.
- Platelet rich fibrin can easily be sutured to surgical site.
Benefits of this study to patients:
- Treatment of cystic lesions.
- Enhancement of bone regeneration.
Benefits of this study for other clinicians:
The study provides a new modality for the regeneration of new bone after cystic enucleation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Biphasic Bone Graft With Autologous Platelet-rich Fibrin | Active comparator | Procedure: Biphasic Bone Graft Material (BGM) in Combination With Autologous Platelet-rich Fibrin (PRF)Patients will undergo complete removal of the cystic cavity with the application of SYMBIOS biphasic bone graft material in combination with PRF in the cystic cavity |
| Biphasic Bone Graft Material only | Active comparator | Procedure: Biphasic Bone Graft Material (BGM) in Combination With Autologous Platelet-rich Fibrin (PRF)Patients will undergo complete removal of the cystic cavity with the application of SYMBIOS biphasic bone graft material without PRF in the cystic cavity |
Who may qualify
- Ages
- 15 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Age range is 15: 60 years old.
- A maxillary odontogenic cysts larger than 3 cm in size.
Key exclusion criteria (6 listed)
- A maxillary odontogenic cysts smaller than 3 cm in size.
- A mandibular odontogenic cysts.
- Non odontogenic cysts.
- Patients with thrombotic risk factors or taking anti-platelets drugs.
- Patients with systemic diseases
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 |
|---|---|---|
| Biphasic Bone Graft Material (BGM) in Combination With Autologous Platelet-rich Fibrin (PRF) | Procedure or surgery | Biphasic Bone Graft Material only, Biphasic Bone Graft With Autologous Platelet-rich Fibrin |
Primary outcome
Swelling
Time frame: six weeks
Visual analogue scale
1 secondary outcome
bone regeneration
Time frame: from six to nine months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2018.
- Individual participant dataSharing planned: No
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.
Niven Abal Latif Askar, PhD study director
Assistant Professor of Oral& Maxillofacial Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Biphasic Bone Graft Material (BGM) in Combination With Autologous Platelet-rich Fibrin (PRF) in people with Odontogenic Maxillary Cysts, run by Cairo University at 1 site in Egypt.
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 2 inclusion and 6 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 17 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Sherif AbdelMonem Abdel Aziz, B.D.S. ((+002)01009026713, dr_sherifelsaraf@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Swelling (time frame: six weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Jul 2018.