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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

Sherif AbdelMonem Abdel Aziz, B.D.S. contact

(+002)01009026713

dr_sherifelsaraf@yahoo.com

Egypt1 site, 1 recruiting
  • Faculty of Oral & Dental Medicine Cairo University

    Cairo

    Sherif AbdelMonem Abdel Aziz, BDS, (+002)01009026713, dr_sherifelsaraf@yahoo.com

    Recruiting

Other trials in Egypt

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:

  1. 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 .
  2. Higher concentration of thrombin impedes cell migration during bone healing.
  3. 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:

  1. 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.
  2. 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.
  3. 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.

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 groups in NCT03003013
Study groupRoleWhat they receive
Biphasic Bone Graft With Autologous Platelet-rich FibrinActive comparatorPatients 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 onlyActive comparatorPatients 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.

  1. Swelling

    Visual analogue scale

    Measured: six weeks

Secondary outcomes (1)
  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.

  1. First posted26 Dec 2016 (estimated)
  2. Study startNov 2016
  3. Primary completionDec 2018 (estimated)
  4. Study completionDec 2018 (estimated)

Resources

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)
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

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.

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