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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05730400
Other study ID # BMAC for sinus augmentation
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 30, 2022
Est. completion date September 15, 2023

Study information

Verified date February 2024
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Aim : The aim of present study was to evaluate BMAC/bovine graft utilization in Sinus membrane augmentation on bone quality and quantity. Methodology: sixteen patients suffering from atrophic posterior maxilla with sinus pneumatization were randomly divided into two equal groups: study group: the sinus membrane was elevated with BMAC/bovine graft whereas the control group recieved bovine graft only for sinus floor augmentation. All patients will be evaluated at 1 week, 4 months to measure bone height and bone core biopsy for histological assessment at 4 months during implant placement.


Description:

Aim : The aim of present study was to evaluate BMAC/bovine graft utilization in Sinus membrane augmentation on bone height gain and quality of bone on histological assessment. Methodology: sixteen patients suffering from atrophic posterior maxilla with sinus pneumatization were randomly divided into two equal groups: study group: the sinus membrane was elevated with bone marrow aspirate concentrate loaded on bovine graft whereas the control group recieved bovine graft only for sinus floor augmentation. All patients will be evaluated at 1 week, 4 months by CBCT to measure bone height and bone core biopsy for histological assessment at 4 months during implant placement.


Recruitment information / eligibility

Status Completed
Enrollment 12
Est. completion date September 15, 2023
Est. primary completion date August 30, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Patients with missing upper posterior teeth and atrophic posterior maxilla with a residual bone height ranging from 4 to 6 mm - Patients who has as deficient as 4 mm vertical bone height in posterior maxilla that need bone augmentation before delayed implant placement. - Highly motivated patients Exclusion Criteria: - Patients suffering from any systemic disease or those under any medication that may interfere with normal bone healing. - Patients suffering from any sinus pathosis. - Patients with conditions that could potentially compromise BM quality, previous BMA, or acute illness. - Heavy smoker (> 20 cigarettes daily)

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
BMAC loaded on bovine graft
Bone marrow aspirate concentrate loaded on bovine graft for sinus floor augmentation
Bovine graft only
Bovine graft only for sinus floor augmentation

Locations

Country Name City State
Egypt Faculty of Dentistry, department of oral and Maxillofacial Surgery Cairo

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Histological assessment Histological assessment of core biopsy obtained at time of implant placement for percentage of new bone formation and residual graft After 4 months of surgery
Secondary Implant stability implant stability immediately following installation after 4 months using ostell device (ISQ scale) After 4 months of surgery
Secondary Bone gain Vertical bone height gain from sinus floor on cone beam ct Preoperative, immediate and 4 months Postoperative
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