Assessment of Microfragmented Adipose Tissue Loaded on Bovine Graft Versus Bovine Graft Only on Ridge Preservation.
Radiographic and Histomorphometric Assessment of Microfragmented Adipose Tissue Loaded on Bovine Graft on Ridge Preservation Versus Bovine Graft Only for Subsequent Implant Placement in the Maxillary Posterior Region, a Randomized Clinical Trial.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
All patients involved in this study will be divided into two groups; each group will receive a different graft of bone augmentation: Adipose tissue loaded on bovine graft will be utilized for the study group and bovine raft only for the control group.
After 6 months, patients will be evaluated histomorphometrically via core biopsy at the time of implant placement and radiographically via assessment of ridge height on CBCT.
Radiographic assessment that will be achieved by CBCT scan will be used to calculate the changes of bone height from base line (1week) to 6 months postoperatively.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Bshaer Bayashot, BDS
- Phone Number: 01064825199
- Email: bshaer.bayashot@dentistry.cu.edu.eg
Study Contact Backup
- Name: hesham Elhawary, prof
- Phone Number: 01144446373
- Email: hesham.elhawary@dentistry.cu.edu.eg
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Patients requiring implant treatment after tooth extraction due to either unrestorable caries lesions or affected periodontium.
- Age group: above 21 years
- Remaining natural teeth have good periodontal tissue support and occlusion showed sufficient inter arch space for future prosthesis.
Exclusion Criteria:
General contraindications to implant surgery.
- Subjected to irradiation in the head and neck area less than 1 year before implantation.
- Poor oral hygiene and motivation.
- Severe bruxism or clenching.
- Systemic, immunologic, or debilitating diseases that could affect normal bone healing & local pathosis.
- Treated or under treatment of intravenous amino bisphosphonates.
- Active infection or severe inflammation in the area intended for implant placement.
- Patients participating in other studies if the present protocol could not be properly followed.
- Heavy smokers
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: microfragmented adipose tissue
microfragmented adipose tissue loaded on bovine graft on ridge preservation
|
microfragmented adipose tissue loaded on bovine graft on ridge preservation
|
|
Active Comparator: bovine graft
bovine graft only on ridge preservation
|
microfragmented adipose tissue loaded on bovine graft on ridge preservation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quantity of bone (vertical bone height)
Time Frame: Quantity of bone (vertical bone height) by CBCT after 6 months
|
By CBCT
|
Quantity of bone (vertical bone height) by CBCT after 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quality of bone
Time Frame: Histological analysis (Core biopsy) Percentage of newly formed bone after 6 months
|
Histological analysis (Core biopsy) Percentage of newly formed bone
|
Histological analysis (Core biopsy) Percentage of newly formed bone after 6 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- microfragmented adipose tissue
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
All patients involved in this study will be divided into two groups; each group will receive a different graft of bone augmentation: Adipose tissue loaded on bovine graft will be utilized for the study group and bovine raft only for the control group.
For both groups: All Patients of both groups will be evaluated radiographically immediately and after 6 months post-operative by cone beam CT scan to record Alveolar ridge height.
IPD Sharing Time Frame
After 6 months, patients will be evaluated histomorphometrically via core biopsy at the time of implant placement and radiographically via assessment of ridge height on CBCT.
Radiographic assessment that will be achieved by CBCT scan will be used to calculate the changes of bone height from base line (1week) to 6 months postoperatively.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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