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.
1 other identifier
interventional
22
0 countries
N/A
Brief Summary
Evaluation of maxillary alveolar ridge changes (bone quantity and quality as revealed by Radiographic and Histomorphometry) utilizing microfragmented adipose tissue loaded on bovine graft versus bovine graft only for maxillary posterior ridge preservation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2024
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 10, 2024
CompletedFirst Posted
Study publicly available on registry
June 13, 2024
CompletedStudy Start
First participant enrolled
July 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2025
CompletedJune 13, 2024
June 1, 2024
7 months
June 10, 2024
June 10, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Quantity of bone (vertical bone height)
By CBCT
Quantity of bone (vertical bone height) by CBCT after 6 months
Secondary Outcomes (1)
Quality of bone
Histological analysis (Core biopsy) Percentage of newly formed bone after 6 months
Study Arms (2)
microfragmented adipose tissue
EXPERIMENTALmicrofragmented adipose tissue loaded on bovine graft on ridge preservation
bovine graft
ACTIVE COMPARATORbovine graft only on ridge preservation
Interventions
microfragmented adipose tissue loaded on bovine graft on ridge preservation
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- principal investigator
Study Record Dates
First Submitted
June 10, 2024
First Posted
June 13, 2024
Study Start
July 1, 2024
Primary Completion
February 1, 2025
Study Completion
March 1, 2025
Last Updated
June 13, 2024
Record last verified: 2024-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- 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.
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.