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Patient Satisfaction and Bone Gain Following Autogenous Particulate Sticky Bone Preparation With Xenograft Versus Without Xenograft for Grafting of Maxillary Anterior Knife Edge Ridge in Partially Edentulous Patients for Implant Placement

Primary Purpose

Alveolar Bone Loss, Bone Graft; Complications

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Sticky bone augmentation
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alveolar Bone Loss focused on measuring implant , sticky bone

Eligibility Criteria

18 Years - 48 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • - Alveolar bone width 3mm or less in anterior maxillary knife edge ridge as evaluated preoperatively on the CBCT
  • Both sexes.
  • Good oral hygiene.
  • Age between 18 and 48 years. Highly motivated patients

Exclusion Criteria:

  • - Patient with Bad oral hygiene
  • Post-menopausal females with osteoporosis
  • Patient with uncontrolled systemic disease For instance: uncontrolled Diabetes Mellitus

Sites / Locations

  • School of Dentistry , Cairo University.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

anterior knife-edge maxilla graft (Without Xenograft Usage)

anterior knife edge maxilla graft (With Xenograft Usage)

Arm Description

The intervention will be a Sticky bone augmentation of defect. It is prepared using particulate autologous graft only along with fibrin glue and growth factors obtained from the patients' blood. The sample is withdrawn and placed in plastic tubes which are spun twice in a centrifuge at a certain speed and time. The first spin to obtain the fibrin glue and the second to obtain the growth factors. The mixture is added to the harvested autogenous bone to form a semi-solid bone graft that is easily manipulated in the recipient site.

The intervention will be the sticky bone augmentation of the defect using both particulate autogenous and xenograft bovine bone. The bone will be harvested from the donor, coupled with the bovine bone, the growth factors and the fibrin glue that is obtained from the patient's own blood sample. The venous blood sample is placed in plastic tubes to be centrifuged at a certain speed and time to obtain the fibrin glue and growth factors. The mixture is prepared until the bone is sticky and ready to be placed in the recipient defective maxilla

Outcomes

Primary Outcome Measures

Patient satisfaction
Patient satisfaction with the bone gain and the prosthetic implant placement

Secondary Outcome Measures

bone width gain
measured in mm
Successful implant placement
it will be measured using OsstellISQ

Full Information

First Posted
April 3, 2018
Last Updated
June 20, 2018
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT03556111
Brief Title
Patient Satisfaction and Bone Gain Following Autogenous Particulate Sticky Bone Preparation With Xenograft Versus Without Xenograft for Grafting of Maxillary Anterior Knife Edge Ridge in Partially Edentulous Patients for Implant Placement
Official Title
Patient Satisfaction and Bone Gain Following Autogenous Particulate Sticky Bone Preparation With Xenograft Versus Without Xenograft for Grafting of Maxillary Anterior Knife-edge Ridge in Partially Edentulous Patients for Implant Placement
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2018 (Anticipated)
Primary Completion Date
July 2019 (Anticipated)
Study Completion Date
August 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The aim is to evaluate the value and efficiency of sticky bone in the augmentation of alveolar ridge deficiency when being used with or without xenogenic bone graft for esthetic implant placement.
Detailed Description
Modern Dentistry aims to restore what is missing, no matter what the difficulty is. As many patients have lost their teeth to a number of factors, either trauma or disease or lack of care. Now the individuals are seeking to restore the function and esthetics. The more the number of teeth is missing along with ridge deficiencies can present serious challenges to the clinician. Implant supported prosthesis is an attractive option for restoring edentulous or partially edentulous patients. However, extensive loss of the alveolar bone is a complex problem that faces many surgeons. This era has witnessed numerous trials and research for bone augmentation for the defective alveolar ridge. The goal is to create sufficient space for endosseous implant placement in a knife edge ridge. Alveolar bone resorption occurs in either a horizontal or vertical direction. It can also be composite. There are 3 classes of bone-grafting materials based upon the mode of action. Autogenous bone is an organic material and forms bone by osteogenesis, osteoinduction, and osteoconduction. Allografts such as demineralized freeze-dried bone are osteoinductive and osteoconductive and may be cortical and/or trabecular in nature. Alloplasts such as hydroxyapatite and tricalcium phosphate may be synthetic or natural, vary in size, and are only osteoconductive. They can be divided into three types based upon the porosity of the product and include dense, macroporous, and microporous materials. In addition, alloplastic materials may be crystalline or amorphous. These materials have different properties and therefore indications. Previous studies have shown that although the autogenous bone is considered as the Gold Standard of bone grafting for its osteogenic potential, many drawbacks exist which limits its application. For instance, donor site morbidity is of concern. Bone harvesting procedures may put adjacent anatomical structures at a risk of damage. During chin bone harvesting, the mental nerve may be pulled under undue traction and the incisive nerve become interrupted when the harvesting depth is inordinate. Ramus bone harvesting can damage the inferior alveolar nerve. In addition, some patients may be reluctant to the harvesting procedures, especially when extra-oral donor sites are concerned. General anesthesia is mandatory for such operations. Recent research studies have looked into modifying the surgical techniques in order to regain the space for an implant along with finding satisfying esthetic outcomes. The literature shows the positive use of ridge splitting technique and alveolar distractors, with or without the aid of xenograft material and/or alloplastic material. Starting from the early 2000s, a new drift of guided bone regeneration research blew by. Platelet concentrates (PC); platelet-rich plasma (PRP) and platelet-rich fibrin (PRF)] were used for surgical procedures in medical and dental fields, particularly in Oral and Maxillofacial surgery, plastic surgery and sports medicine. They were utilized to accelerate healing of bone graft over the bony defects, many techniques utilizing platelet and fibrinogen concentrations have been introduced in the literature. Platelet is known to contain high quantities of growth factors, such as transforming growth 4 . Factors ß-1 (TGFß-1), platelet-derived growth factor (PDGF), epithelial growth factor (EGF), insulin growth factor-I (IFG-I) and vascular endothelial growth factors (VEGF), which stimulates cell proliferation and upregulates angiogenesis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alveolar Bone Loss, Bone Graft; Complications
Keywords
implant , sticky bone

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
anterior knife-edge maxilla graft (Without Xenograft Usage)
Arm Type
Experimental
Arm Description
The intervention will be a Sticky bone augmentation of defect. It is prepared using particulate autologous graft only along with fibrin glue and growth factors obtained from the patients' blood. The sample is withdrawn and placed in plastic tubes which are spun twice in a centrifuge at a certain speed and time. The first spin to obtain the fibrin glue and the second to obtain the growth factors. The mixture is added to the harvested autogenous bone to form a semi-solid bone graft that is easily manipulated in the recipient site.
Arm Title
anterior knife edge maxilla graft (With Xenograft Usage)
Arm Type
Experimental
Arm Description
The intervention will be the sticky bone augmentation of the defect using both particulate autogenous and xenograft bovine bone. The bone will be harvested from the donor, coupled with the bovine bone, the growth factors and the fibrin glue that is obtained from the patient's own blood sample. The venous blood sample is placed in plastic tubes to be centrifuged at a certain speed and time to obtain the fibrin glue and growth factors. The mixture is prepared until the bone is sticky and ready to be placed in the recipient defective maxilla
Intervention Type
Procedure
Intervention Name(s)
Sticky bone augmentation
Intervention Description
Autogenous sticky bone augmentation for the first group Autogenous sticky bone preparation with xenograft usage After 5-month of bone grafting; esthetic implant placement
Primary Outcome Measure Information:
Title
Patient satisfaction
Description
Patient satisfaction with the bone gain and the prosthetic implant placement
Time Frame
8 months after bone graft placement
Secondary Outcome Measure Information:
Title
bone width gain
Description
measured in mm
Time Frame
5 month after bone graft placement
Title
Successful implant placement
Description
it will be measured using OsstellISQ
Time Frame
5 months after bone graft placement

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
48 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: - Alveolar bone width 3mm or less in anterior maxillary knife edge ridge as evaluated preoperatively on the CBCT Both sexes. Good oral hygiene. Age between 18 and 48 years. Highly motivated patients Exclusion Criteria: - Patient with Bad oral hygiene Post-menopausal females with osteoporosis Patient with uncontrolled systemic disease For instance: uncontrolled Diabetes Mellitus
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
nesma m ibrahim, BDS
Phone
00201000750518
Email
nesmamattar@outlook.com
First Name & Middle Initial & Last Name or Official Title & Degree
mostafa I Shindy, PHD
Phone
00201121112222
Facility Information:
Facility Name
School of Dentistry , Cairo University.
City
Cairo
State/Province
Giza
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

Patient Satisfaction and Bone Gain Following Autogenous Particulate Sticky Bone Preparation With Xenograft Versus Without Xenograft for Grafting of Maxillary Anterior Knife Edge Ridge in Partially Edentulous Patients for Implant Placement

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