Back to resultsRadiographic and Histological Evaluation of Regenerated Bone After Grafting Using Allograft Shell and Autogenous Chips (Shell grafting)
Primary Purpose
Alveolar Bone Resorption
Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Horizontal alveolar bone augmentation
Sponsored by
About this trial
This is an interventional treatment trial for Alveolar Bone Resorption focused on measuring Allograft, Autogenous chips, Horizontal augmentation, Khoury shell technique
Eligibility Criteria
Inclusion Criteria:
- Patients with class IV of Cawood and Howell classification in the anterior maxilla.
- Males and females 18-50 years of age.
- Patients with adequate oral hygiene.
- Patients with healed sites for at least 6 months after tooth extraction.
- Patients with an inter-arch distance of at least 6 mm.
- Compliance with all requirements in the study and signing the informed consent.
Exclusion Criteria:
- Patients with diseases of the immune system or systemic disease affecting bone healing
- Patients who are chronic users of medications known to affect the periodontal status.
- Patients with history of intravenous and/or oral bisphosphonate use.
- Pathologic lesions or acute infection in the area of defect.
- Patients who are pregnant or lactating mothers.
- Heavy smokers who smoke more than 10 cigarettes a day.
- Patients with poor oral hygiene that are not amenable to motivation and improvement.
- Patients with history of irradiation of the head and neck region.
- Vulnerable patients.
Sites / Locations
- Faculty of Dentistry Ain Shams University
Outcomes
Primary Outcome Measures
Alveolar Bone quantity
Alveolar bone width by millimeters using Cone Beam Computed Tomography
Secondary Outcome Measures
Alveolar Bone quality
Histological evaluation of status of regenerated bone vitality and remodeling
Full Information
NCT ID
NCT04324697
First Posted
March 23, 2020
Last Updated
June 6, 2020
Sponsor
October 6 University
Collaborators
Ain Shams University
1. Study Identification
Unique Protocol Identification Number
NCT04324697
Brief Title
Radiographic and Histological Evaluation of Regenerated Bone After Grafting Using Allograft Shell and Autogenous Chips
Acronym
Shell grafting
Official Title
Evaluation of Anterior Alveolar Ridge Reconstruction With Allogenic Bone Plate and Autogenous Cortical Bone Chips: A Radiographic and Histological Clinical Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
April 8, 2018 (Actual)
Primary Completion Date
July 1, 2019 (Actual)
Study Completion Date
September 5, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
October 6 University
Collaborators
Ain Shams 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 clinical cases in the present study described the khoury shell technique using an allograft plate and autogenous chips, for horizontal reconstruction of the anterior alveolar ridge in the esthetic zone. Without need to use autogenous bone graft techniques that are characterized by more aggressive surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alveolar Bone Resorption
Keywords
Allograft, Autogenous chips, Horizontal augmentation, Khoury shell technique
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
Reconstruction of the localized deficient anterior maxilla using an allograft cortical bone plate, which was fixed at a distance from the alveolar ridge using two micro-screws, and the created gap between the allograft plate and the alveolar ridge was filled with autogenous cortical bone chips harvested intraorally using a bone scrapper.
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Horizontal alveolar bone augmentation
Other Intervention Name(s)
MAXGRAFT@Cortico - Botiss
Intervention Description
Horizontal augmentation in anterior maxilla using allograft shell and autogenous chips with no need for a second surgical site
Primary Outcome Measure Information:
Title
Alveolar Bone quantity
Description
Alveolar bone width by millimeters using Cone Beam Computed Tomography
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Alveolar Bone quality
Description
Histological evaluation of status of regenerated bone vitality and remodeling
Time Frame
7 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with class IV of Cawood and Howell classification in the anterior maxilla.
Males and females 18-50 years of age.
Patients with adequate oral hygiene.
Patients with healed sites for at least 6 months after tooth extraction.
Patients with an inter-arch distance of at least 6 mm.
Compliance with all requirements in the study and signing the informed consent.
Exclusion Criteria:
Patients with diseases of the immune system or systemic disease affecting bone healing
Patients who are chronic users of medications known to affect the periodontal status.
Patients with history of intravenous and/or oral bisphosphonate use.
Pathologic lesions or acute infection in the area of defect.
Patients who are pregnant or lactating mothers.
Heavy smokers who smoke more than 10 cigarettes a day.
Patients with poor oral hygiene that are not amenable to motivation and improvement.
Patients with history of irradiation of the head and neck region.
Vulnerable patients.
Facility Information:
Facility Name
Faculty of Dentistry Ain Shams University
City
Cairo
ZIP/Postal Code
11566
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Radiographic and Histological Evaluation of Regenerated Bone After Grafting Using Allograft Shell and Autogenous Chips
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