ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 4 of 106 for:    Recruiting, Not yet recruiting, Available Studies | "Bone Transplantation"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03003013
Recruitment Status : Recruiting
First Posted : December 26, 2016
Last Update Posted : July 17, 2018
Sponsor:
Information provided by (Responsible Party):
Sherif Abdel Monem Abdel Aziz, Cairo University

Brief 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

Condition or disease Intervention/treatment Phase
Odontogenic Maxillary Cysts Procedure: Biphasic Bone Graft Material (BGM) in Combination With Autologous Platelet-rich Fibrin (PRF) Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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
Actual Study Start Date : November 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bone Grafts

Arm Intervention/treatment
Active Comparator: Biphasic Bone Graft With Autologous Platelet-rich Fibrin
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
Procedure: Biphasic Bone Graft Material (BGM) in Combination With Autologous Platelet-rich Fibrin (PRF)
Active Comparator: Biphasic Bone Graft Material only
Patients will undergo complete removal of the cystic cavity with the application of SYMBIOS biphasic bone graft material without PRF in the cystic cavity
Procedure: Biphasic Bone Graft Material (BGM) in Combination With Autologous Platelet-rich Fibrin (PRF)



Primary Outcome Measures :
  1. Swelling [ Time Frame: six weeks ]
    Visual analogue scale


Secondary Outcome Measures :
  1. bone regeneration [ Time Frame: from six to nine months ]
    Gray scale value via cone beam CT



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   15 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Inclusion criteria

  1. Age range is 15: 60 years old.
  2. A maxillary odontogenic cysts larger than 3 cm in size.

Exclusion criteria

  1. A maxillary odontogenic cysts smaller than 3 cm in size.
  2. A mandibular odontogenic cysts.
  3. Non odontogenic cysts.
  4. Patients with thrombotic risk factors or taking anti-platelets drugs.
  5. Patients with systemic diseases

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03003013


Contacts
Contact: Sherif AbdelMonem Abdel Aziz, B.D.S. (+002)01009026713 dr_sherifelsaraf@yahoo.com

Locations
Egypt
Faculty of Oral & Dental Medicine Cairo University Recruiting
Cairo, Egypt
Contact: Sherif AbdelMonem Abdel Aziz, BDS    (+002)01009026713    dr_sherifelsaraf@yahoo.com   
Sponsors and Collaborators
Cairo University
Investigators
Study Director: Niven Abal Latif Askar, PhD Assistant Professor of Oral& Maxillofacial Surgery

Responsible Party: Sherif Abdel Monem Abdel Aziz, Master student, Cairo University
ClinicalTrials.gov Identifier: NCT03003013     History of Changes
Other Study ID Numbers: CU
First Posted: December 26, 2016    Key Record Dates
Last Update Posted: July 17, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Sherif Abdel Monem Abdel Aziz, Cairo University:
Odontogenic cysts
Bone substitutes materials
SYMBIOS®
Platelets rich fibrin (PRF)
Bone regeneration

Additional relevant MeSH terms:
Cysts
Neoplasms
Pathological Conditions, Anatomical