Assessment of Dimensional Changes Following Grafting With Microfragmented Adipose Tissue Loaded on Allograft on Ridge Preservation
Assessment of Dimensional Changes Following Grafting With Microfragmented Adipose Tissue Loaded on Allograft on Ridge Preservation Versus Allograft 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 allograft will be utilized for the study group and allograft only for the control group.
After 3-6 months, assessment of dimensional changes ( RG height & width) on CBCT is performed and Histomorphometry will be evaluated via core biopsy at the time of implant placement in both groups.
Radiographic assessment that will be achieved by CBCT scan will be used to calculate the changes of bone height and width from base line (1week) to 3-6 months postoperatively.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: hesham Elhawary, prof
- Phone Number: 01144446373
- Email: hesham.elhawary@dentistry.cu.edu.eg
Study Contact Backup
- Name: maha alnahdi, BDS
- Phone Number: 01559975945 01145684357
- Email: maha.alnahdi@dentistry.cu.edu.eg
Study Locations
-
-
Giza
-
Cairo, Giza, Egypt
- Cairo Universty
-
Contact:
- hesham Elhawary, prof
- Phone Number: 01144446373
- Email: hesham.elhawary@dentistry.cu.edu.eg
-
Contact:
- Maha Alnahdi, BDS
- Phone Number: 01559975945
- Email: maha.alnahdi@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 18 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 somkers
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 allograft on ridge preservation
|
microfragmented adipose tissue loaded on allograft on ridge preservation
|
|
Active Comparator: allograft
allograft only on ridge preservation
|
microfragmented adipose tissue loaded on allograft on ridge preservation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Alveolar ridge hight (bone quantity )
Time Frame: Alveolar ridge hight (bone quantity ) by CBCT after 3-6 months
|
By CBCT
|
Alveolar ridge hight (bone quantity ) by CBCT after 3-6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Alveolar ridge width.
Time Frame: Alveolar ridge width. by CBCT after 3-6 months
|
By CBCT
|
Alveolar ridge width. by CBCT after 3-6 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
Other Study ID Numbers
- Assessment of dimensional chan
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 allograft will be utilized for the study group and allograft only for the control group.
For both groups: All Patients of both groups will be evaluated radiographically immediately and after 3- 6 months post-operative by cone beam CT scan to record Alveolar ridge height and width.
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 and width 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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