Horizontal Ridge Reconstruction of Atrophic Anterior Maxillary Ridges Using Customized Xenograft Bone Shell With 1 :1 Mixture of Autogenous and Xenograft Bone Particulate
Primary Purpose
Atrophic Anterior Maxillary Ridges
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Atrophic Anterior Maxillary Ridges
Sponsored by
About this trial
This is an interventional treatment trial for Atrophic Anterior Maxillary Ridges
Eligibility Criteria
Inclusion Criteria:
- patients with atrophic Anterior Maxillary Ridges
Exclusion Criteria:
- Heavy smokers
- Uncontrolled diabetic patients.
- Pregnant patients. Psychiatric patient
- pathology related to bone.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Atrophic Anterior Maxillary Ridges participants
Arm Description
Using customized Xenograft bone shell with equal mixture of autogenous and xenograft particulate bone as a graft with the modified cortical shell technique, with atrophic anterior maxilla with less than 5 mm Bucco-lingual
Outcomes
Primary Outcome Measures
Bucco-lingual bone width gain.
Secondary Outcome Measures
Full Information
NCT ID
NCT04075942
First Posted
August 28, 2019
Last Updated
January 25, 2021
Sponsor
Manal Ahmed Hassan Ahmed
1. Study Identification
Unique Protocol Identification Number
NCT04075942
Brief Title
Horizontal Ridge Reconstruction of Atrophic Anterior Maxillary Ridges Using Customized Xenograft Bone Shell With 1 :1 Mixture of Autogenous and Xenograft Bone Particulate
Official Title
Horizontal Ridge Reconstruction of Atrophic Anterior Maxillary Ridges Using Customized Xenograft Bone Shell With 1 :1 Mixture of Autogenous and Xenograft Bone Particulate
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 2021 (Anticipated)
Primary Completion Date
January 2021 (Anticipated)
Study Completion Date
January 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Manal Ahmed Hassan Ahmed
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
Using customized Xenograft bone shell with mixture of autogenous and xenograft particulate in modified cortical shell technique. by 3D printed model from The CT scans segmentation by special software
Detailed Description
Using customized Xenograft bone shell by 3D printed model from The CT scans segmentation by special software ( Mimics ) . All surgeries were performed by the same surgeon .
All surgical procedures were performed under strict aseptic conditions, all patients received infiltration local anesthesia (Articaine 4% 1:100 000 epinephrine).
a midcrestal incision was made in the anterior region using No. 15 blade. A full thickness mucoperiosteal flap was raised to expose the underlying alveolar ridge. The residual remaining bone in the area was minimal, with a maximum measured ridge thickness of 3 or 4 mm. 'To reconstruct the lost alveolar bone, an xenograft bone shell approximately 1 to 2 mm thick was shaped, after 3D print the bone shell were fixed to the buccal defect, using screws . 'The space between the plate and the existing palatal bone wall was then filled using a combination of autograft bone chips and xenograft bone particles
. Periosteal releasing incision is done to obtain stress free primary closure. The flap will then be closed using interrupted 4/0 resorbable sutures. After 4 month will insert implant . After 3 month will insert final restoration which will be mostly PMF .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrophic Anterior Maxillary Ridges
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Atrophic Anterior Maxillary Ridges participants
Arm Type
Other
Arm Description
Using customized Xenograft bone shell with equal mixture of autogenous and xenograft particulate bone as a graft with the modified cortical shell technique, with atrophic anterior maxilla with less than 5 mm Bucco-lingual
Intervention Type
Procedure
Intervention Name(s)
Atrophic Anterior Maxillary Ridges
Intervention Description
Use of modified cortical shell technique grafted with customized Xenograft bone shell
Primary Outcome Measure Information:
Title
Bucco-lingual bone width gain.
Time Frame
4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
patients with atrophic Anterior Maxillary Ridges
Exclusion Criteria:
Heavy smokers
Uncontrolled diabetic patients.
Pregnant patients. Psychiatric patient
pathology related to bone.
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Horizontal Ridge Reconstruction of Atrophic Anterior Maxillary Ridges Using Customized Xenograft Bone Shell With 1 :1 Mixture of Autogenous and Xenograft Bone Particulate
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