Neoplasms

Symptoms and General Pathology

All Conditions

Musculoskeletal Diseases

Mouth and Tooth Diseases

Cysts

Odontogenic Cysts

Jaw Cysts

Bone Cysts

Jaw Diseases

Stomatognathic Diseases

Active decompression

Null hypothesis active decompression and distraction sugosteogenesis is not faster than passive decompression in volume reduction of large cystic lesions

Volumetric Changes in Large Cystic Lesions Using Active Decompression and Distraction Sugosteogenesis vs Passive Decompression

In Patients With Large Cystic Lesion Does Volume Reduction Occurs Faster by Using Active Decompression and Distraction Sugosteogenesis Than Using Passive Decompression

Radwa Hydar Ragab

Principle investigator

Pathological Conditions, Anatomical

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

Patients will undergo complete removal of the cystic cavity with the application of SYMBIOS biphasic bone graft material without PRF in the cystic cavity

Biphasic Bone Graft Material (BGM) in Combination With Autologous Platelet-rich Fibrin (PRF)

Sherif AbdelMonem Abdel Aziz, B.D.S.

Sherif AbdelMonem Abdel Aziz, BDS

Niven Abal Latif Askar, PhD

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

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.

Effect of Biphasic Bone Graft Material With Autologous Platelet-rich Fibrin on Bone Regeneration in a Maxillary Cyst

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

Cairo University

Master student

Central Nervous System Depressants

All Drugs and Chemicals

Anesthetics

Cystostomy procedure is carried out with the same day delivery of a decompression appliance fabricated with a fully digital workflow. Enucleation of the cyst is carried out following decompression.

CBCT scans (Green X, Vatech, Hwaseong, Korea) are carried out prior to cystostomies. The scanning conditions are constant at 200 µm isotropic voxel size with 360° rotation, 94 kV tube voltage, 7.2 mA tube current and 9 s exposure time with a 15 × 8 cm field of view field of view (FOV).

Preoperative Cone Beam Computed Tomography (CBCT) scan

Surgical interventions are carried out in local anaesthesia. If it is deemed that a tooth or teeth included in the odontogenic cyst is of hopeless prognosis, it is removed at the time of cystostomy procedure. During cystostomy a bony window is created to accessthe cyst. The lining of the cyst is opened to accomodate the tube of the decompression appliance. A sample from the lining of the cyst is sent for histologic evaluation to confirm the diagnosis of odontogenic cyst.

tooth removal and cystostomy

The decompression appliances is delivered in the same sitting as the cystostomy. Patients are instructed on how to wear and clean their decompression device and are recalled for clinical examinations.

Decompression

Postoperative CBCT examination is performed six months into the decompression period using the same scanning conditions as those used for the preoperative CBCT scan.

Postoperative Cone Beam Computed Tomography (CBCT) scan

Following the decompression period enucleation of the remaining cyst is carried out in local anaesthesia.

Cyst Enucleation

Márton Kivovics, DMD MSc PhD

Dorottya Pénzes, DMD MSc

The aim of this prospective case series is to present clinical results with cystostomy, decompression and final enucleation of odontogenic cysts using a decompression device fabricated with a full digital workflow and delivered on the day of cystostomy. The secondary purpose of our study is to present the volumetric changes of the odontogenic cysts treated by decompression.

Cystostomy and decompression Patients rinse with 0.2% chlorhexidine solution for 1 min before surgery. Under local anesthesia, an envelope flap from marginal incision is elevated and teeth deemed for extraction are removed in an atraumatic manner. In those cases where the cyst may not be accessed from the sockets of the teeth removed osteotomies are carried out by round burs using a surgical handpiece (SURGmatic S11 L Pro , Kavo Dental, Brea, California, United States) and motor (MASTERsur LUX, Kavo Dental, Brea, California, United States) to create a bony window. A histological sample is collected from the cyst lining to confirm the initial diagnosis of odontogenic cyst. Wound margins are stabilized using single interrupted sutures. The decompression appliance is delivered in the same sitting. Patients are instructed on how to wear and clean their decompression device. Antibiotics (1 g amoxicillin-clavulanate twice a day for 5 days or, in case of side effects or known allergy to penicillin, 300 mg clindamycin 4 times a day for 4 days), non-steroid anti-inflammatory drugs (50 mg diclofenac 3 times a day for 3 days), and chlorhexidine mouthwash (twice a day for 21 days from the first day after surgery) are prescribed. Sutures are removed after 7 days

Postoperative imaging Postoperative CBCT examination is performed six months into the decompression period using the same scanning conditions as those used for the preoperative CBCT scan.

Data acquisition Pre- and postoperative CBCT reconstructions are registered by landmark registration using the 3DSlicer 4.10.2 (The Brigham and Women's Hospital, Inc., Boston, MA, USA) software. The volume of the odontogenic cysts before (Preoperative Volume) and following (Postoperative Volume) decompression are assessed by manual segmentation using the segment editor and segment statistics plug-in. Volume Reduction is calculated by subtracting the Postoperative Volume from the Preoperative Volume. Percentage of Volume Reduction is calculated as follows: Volume Reduction/Preoperative Volume X 100.

Decompression Decompression is maintained until the cyst reduces in volume to an extent, that enucleation may be performed with minimal risk of complications (damage to the anatomical landmarks blood vessels, nerves, roots of neighboring teeth, nasal cavity, maxillary sinuses). During the decompression period patients are recalled for clinical examination and radiographic control (panoramic radiographs) monthly.

Enucleation Following decompression enucleation of the remaining cyst is carried out under local anaesthesia.

Patients are recalled for clinical examination and radiographic control (panoramic radiographs) a year after enucleation to determine whether recurrence of the odontogenic cyst occurs or not.

Decompression of Odontogenic Cysts Using an Appliance Fabricated With a Fully Digital Workflow

The odontogenic cyst is resolved clinically and radiologically by bony healing

During follow up recurrence of the odontogenic cyst is observed

Volumetric changes of the cyst cavity during decompression.

Semmelweis University

Head of the Oral Surgery Unit

Guided lid surgery is performed to reduce the loss of bone post operative

The patient will receive active ordinary treatment for removal of odontogenic cysts

surgical cutting guide with piezo

control

yasser el hadidi

Marwa El Kassaby

mohamed diaa

to evaluate the percentage of bone volume regain along with postoperative pain in cases done using the bone lid technique in comparison with those done using the conventional cyst enucleation technique.

The study will involve eighteen patients selected from the outpatient clinic, Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Ain Shams University.

The patients included in this study will be informed about the full details of this research and they will sign an informed consent. Moreover, this research will be reviewed by the research ethics committee, Faculty of Dentistry, Ain Shams University.

Randomization:

The study consists of two groups each containing 10 patients. Patients will be randomly allocated according to predetermined computer-generated randomization using (www.randomizer.org).

PICO:

P: Patients with expansile cystic lesions with intact bony cortex of a minimum 1mm thickness.

I: Cyst enucleation using the bone lid technique and piezoelectric device. C: Cyst enucleation using the conventional buccal bone ostectomy technique. O: Percentage of bone volume recovery. T: 6 months postoperative.

Inclusion criteria:

1. Age ranging from 18-60 years.
2. Have free medical history or controlled systemic disease.
3. Expansile cystic lesion with intact cortical bone extending from 2-6 teeth.
4. A minimum thickness of 1 mm of the cortical bone.

Exclusion criteria:

1. Patients with history of surgery in the area affected by the cystic lesion.
2. Patients with suspected malignant tumors in the area.

Pre-operative assessment:

Proper history is obtained followed by palpation of the affected area to check tenderness or suspected superimposed infection. Aspiration biopsy is done to ensure the nature of the lesion being cystic. Cone Beam Computed Tomography (CBCT) is done to assess the exact size of the lesion and plan for the surgical cutting guide.

Patients with intact cortical bone related to the cystic lesion will be enrolled in this study. All patients will receive full information about the procedures where the risks and benefits will be thoroughly explained to them. They will then be asked to give their consent.

Sample size calculation:

Considering that there was around 93% difference between the cystic cavity before and after lid surgery with enucleation (19). After setting the α at 0.05 and β at 0.2; the minimal sample size was calculated and revealed that the minimum number to achieve statistical data was 10 patients in each goup (total number of patients= 20).

Pre-operative patient preparation:

1. Fasting for 6-8 hours before the procedure.
2. Laboratory investigations to assess his/ her medical condition if the procedure is to be performed under general anesthesia;

   * Complete blood count (CBC).
   * Bleeding profile; PT, PTT, INR.
   * Liver function test.
   * Kidney function test.
   * Blood sugar level; fasting and 2-hours post-brandial.

Surgical procedure:

Anesthetizing the surgical area is done using the selected suitable nerve block technique with articaine 4% and 1:100,000 epinephrine.

1. Flap reflection:

   A full thickness muco-periosteal flap is reflected using no.15 blade. The extent of the flap incisions shall involve one tooth mesial to the lesion and one tooth distal to the lesion.
2. Surgical guide fixation:

   The surgical cutting guide is adapted in place and fixed using micro-screws to ensure proper stability of the guide and accuracy of the bony window.
3. Bone lid fabrication:

   The bony window is cut guided by the edges in the cutting guide using piezoelectric device under copious irrigation. The window is then dissected bluntly from the attached cystic lesion using a muco-periosteal elevator and a bone curette.
4. Enucleation of the cystic lesion:

   The lesion is carefully separated from the surrounding bone using a muco-periosteal elevator and a bone curette while being held with a toothed tissue forceps or Allis forceps. The excised lesion will be placed in a jar containing 10% formaldehyde to be sent to the Oral Pathology lab for excisional biopsy confirmation of the nature of the lesion. This is followed by careful curettage of the surgical bed to ensure absence of any remnants of the lesion followed by rinsing using isotonic saline solution.
5. Fixation of the bone lid:

   The previously removed bone lid is reoriented back in place and fixed using 2.3 micro-plates and micro-screws for rigid fixation.
6. Closure of the flap:

The flap is sutured using 4-0 vicryl resorbable suture to achieve primary closure.

The control group will be done using the conventional buccal ostectomy technique by reflection of a full thickness mucoperiosteal flap followed by removal of part of the cortical bone to allow enough access to the cystic lesion. The lesion is enucleated afterwards by removing the entire lining and the flap is closed at the end of the procedure using 4-0 vicryl resorbable suture. No surgical guide is used and the removed part of the cortical bone is grinded using a high speed handpiece, a rounded surgical bur and a bone curette.

Immediate post-operative medications:

1. Amoxicillin/ clavulanate 1gm tablets every 12 hours for 5 days.
2. Chymotrypsin 300E.A.U. 2 tablets every 8 hours for 5 days.
3. Ibuprofen 600mg tablets every 12 hours for 5 days.

Immediate post-operative instructions:

1. Avoid vigorous rinsing or spitting for the first 24 hours.
2. Place ice packs over the surgical area for 10 minutes and repeated every 30 minutes over the first 6 hours.
3. Avoid hot, hard or crunchy food for the first 3 days.
4. After 24 hours, start rinsing with warm isotonic saline solution 3 times per day for 7 days.
5. After 24 hours, start placing warm packs over the surgical area 3 times per day for 7 days.

Follow up:

1. Percentage of bone volume regained will be evaluated using CBCT 6 months after the intervention (a total of 2 CBCTs; one pre-operative and one 6 months post-operative).
2. Pain will be assessed immediately postoperative and after 6 months by Visual Analog Scale from (0-10), as 0 means absence of pain and 10 means maximum pain.

Randomized clinical trial with 1:1 allocation ratio

The Evaluation of the Effect of Performing Guided Lid Surgery

The Evaluation of the Effect of Performing Guided Lid Surgery With Enucleation of Cystic Lesions Compared to Conventional Cystic Enucleation; a Randomized Clinical Trial

evaluation of pain by exposing patient to a visual analogue scale

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Volumetric Changes in Large Cystic Lesions Using Active Decompression and Distraction Sugosteogenesis vs Passive Decompression	NCT06262802	Odontogenic Cys...	Active decompre...	12 Years - 80 Years	Cairo University
Effect of Biphasic Bone Graft Material With Autologous Platelet-rich Fibrin on Bone Regeneration in a Maxillary Cyst	NCT03003013	Odontogenic Max...	Biphasic Bone G...	15 Years - 60 Years	Cairo University
Decompression of Odontogenic Cysts Using an Appliance Fabricated With a Fully Digital Workflow	NCT05253261	Odontogenic Cys...	Preoperative Co... tooth removal a... Decompression Postoperative C... Cyst Enucleatio...	5 Years -	Semmelweis University
The Evaluation of the Effect of Performing Guided Lid Surgery	NCT05358275	Odontogenic Cys...	surgical cuttin... control	18 Years - 60 Years	Ain Shams University
The Evaluation of the Effect of Performing Guided Lid Surgery	NCT05358275	Odontogenic Cys...	surgical cuttin... control	18 Years - 60 Years	Ain Shams University
Decompression of Odontogenic Cysts Using an Appliance Fabricated With a Fully Digital Workflow	NCT05253261	Odontogenic Cys...	Preoperative Co... tooth removal a... Decompression Postoperative C... Cyst Enucleatio...	5 Years -	Semmelweis University
Effect of Biphasic Bone Graft Material With Autologous Platelet-rich Fibrin on Bone Regeneration in a Maxillary Cyst	NCT03003013	Odontogenic Max...	Biphasic Bone G...	15 Years - 60 Years	Cairo University

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