Vertical and Horizontal Alveolar Ridge Augmentation Using Autogenous Onlay Blocks Combined With Guided Bone Regeneration Using Native Collagen Membrane in Atrophic Anterior Maxilla.
Primary Purpose
Anterior Maxilla With Deficient Ridge Height and/or Width
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
autogenous ring blockls with GBR covered by collagen membrane
Sponsored by
About this trial
This is an interventional treatment trial for Anterior Maxilla With Deficient Ridge Height and/or Width
Eligibility Criteria
Inclusion Criteria:
- Patients with partially edentulous in the anterior area of the maxilla, with a residual ridge that allowed insertion of ≤11.5 mm length implants.
- Both sexes.
- No intraoral soft and hard tissue pathology
- No systemic condition that contraindicate implant placement.
Exclusion Criteria:
- Pathology.
- Heavy smokers more than 20 cigarettes per day.
- Patients with systemic disease that may affect normal healing.
- Psychiatric problems
- Disorders to implant are related to history of radiation therapy to the head and neck neoplasia, or bone augmentation to implant site
- Immunodeficiency pathology, bruxism, stress situation (socially or professionally), emotional instability, and unrealistic aesthetic demands.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
autogenous ring blockls with GBR covered by collagen membrane
Arm Description
Vertical and horizontal ridge augmentation using autogenous onlay ring blocks combined with simultaneous guided bone regeneration using native collagen membrane in atrophic anterior maxilla.
Outcomes
Primary Outcome Measures
Bone gained vertically
Amount of bone gained vertically will be measured using CBCT
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03895060
Brief Title
Vertical and Horizontal Alveolar Ridge Augmentation Using Autogenous Onlay Blocks Combined With Guided Bone Regeneration Using Native Collagen Membrane in Atrophic Anterior Maxilla.
Official Title
Vertical and Horizontal Alveolar Ridge Augmentation Using Autogenous Onlay Ring Blocks Combined With Simultaneous Guided Bone Regeneration Using Native Collagen Membrane in Atrophic Anterior Maxilla.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2019 (Anticipated)
Primary Completion Date
March 1, 2020 (Anticipated)
Study Completion Date
March 30, 2020 (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
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Many different techniques exist for effective vertical bone augmentation, such as the use of particulate bone grafts and bone graft substitutes, barrier membranes for guided bone regeneration (GBR), autogenous and allogenic block grafts, and the application of distraction osteogenesis. Harvesting of autogenous block grafts is associated with greater morbidity compared with the less invasive procedure of using autogenous particles harvested through bone scrapers. On the other hand, particulate grafts always require a space-maintaining barrier, or their physical properties would not allow three-dimensional bone regeneration as those of block grafts do.
Detailed Description
An autogenous ring block is harvested from the chin area by trephine bur and the autogenous bone chips will be collected with a bone scraper, then a specially manufactured machine titanium tenting screw is used to fasten the ring block to the alveolar ridge. Two or three ring blocks is screwed according to the defect. Then resorbable collagen membrane is fixed to the alveolar ridge instead of the titanium-reinforced e-PTFE and equally autogenous and xenograft bone particles is packed around the screw to fill the defect area completely. Extreme care is taken to avoid autogenous particles drifting distally toward the area of the block. The barrier membrane was then closed over the block and particulate graft and fixed by bone tacks. Then periosteal releasing incision is done to allow tension free adaption of the mucoperisteal flap.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Maxilla With Deficient Ridge Height and/or Width
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
autogenous ring blockls with GBR covered by collagen membrane
Arm Type
Experimental
Arm Description
Vertical and horizontal ridge augmentation using autogenous onlay ring blocks combined with simultaneous guided bone regeneration using native collagen membrane in atrophic anterior maxilla.
Intervention Type
Device
Intervention Name(s)
autogenous ring blockls with GBR covered by collagen membrane
Intervention Description
A crestal incision is made using No. 15 blade extending over the anterior maxilla, an anterior vertical releasing incision is made and a full mucoperiosteum flaps elevated to provide access to the alveolar ridge and the lateral aspect of the maxilla
Autogenous onlay ring blocks is taken by a trephine bur from the chin area and then fixed by screws to the deficient maxillary alveolar height.
Equally autogenous and xenograft bone particles is packed around the screw to fill the defect area completely.
The collagen membrane is fixed to the alveolar ridge by bone tacks and the mixture of autogenous and xenograft bone is then packed.
The flap will then be closed using interrupted 4/0 resorbable sutures.
Primary Outcome Measure Information:
Title
Bone gained vertically
Description
Amount of bone gained vertically will be measured using CBCT
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with partially edentulous in the anterior area of the maxilla, with a residual ridge that allowed insertion of ≤11.5 mm length implants.
Both sexes.
No intraoral soft and hard tissue pathology
No systemic condition that contraindicate implant placement.
Exclusion Criteria:
Pathology.
Heavy smokers more than 20 cigarettes per day.
Patients with systemic disease that may affect normal healing.
Psychiatric problems
Disorders to implant are related to history of radiation therapy to the head and neck neoplasia, or bone augmentation to implant site
Immunodeficiency pathology, bruxism, stress situation (socially or professionally), emotional instability, and unrealistic aesthetic demands.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Reham Dewedar, BDS
Phone
+201018418031
Email
rehammoemen20@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed Atef, PhD
Phone
+201009612708
Email
zokasur@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Vertical and Horizontal Alveolar Ridge Augmentation Using Autogenous Onlay Blocks Combined With Guided Bone Regeneration Using Native Collagen Membrane in Atrophic Anterior Maxilla.
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