Clinical trial NCT05730400: Histological Assessment of BMAC Utilized in Sinus Lift
Official title: Histological Assessment of Deproteinized Bovine Bone Loaded by Bone Marrow Aspirate Versus Deproteinized Bovine Bone Alone for Guided Sinus Floor Elevation. (A Randomized Controlled Clinical Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Implant Site Reaction
Keywords: Bone marrow
Sinus augmentation
Sinus lift
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-02-15
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Histological assessment
timeFrame: After 4 months of surgery
Secondary outcomes:
measure: Implant stability
timeFrame: After 4 months of surgery
measure: Bone gain
timeFrame: Preoperative, immediate and 4 months Postoperative
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry, department of oral and Maxillofacial Surgery
Study officials:
affiliation: Professor at Faculty of Dentistry Cairo University
name: Maha Hakam, Phd
role: STUDY_DIRECTOR
References: