Histological Assessment of BMAC Utilized in Sinus Lift

Not Applicable

Completed

• Conditions: Implant Site Reaction
• Interventions: Drug: BMAC loaded on bovine graft; Drug: Bovine graft only

• Registration Number: NCT05730400
• Lead Sponsor: Cairo University

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.

Study Timeline

• Study Start: 2022-10-30
• Study First Submitted: 2023-01-26
• Study First Submitted QC: 2023-02-13
• Study First Posted: 2023-02-15
• Primary Completion: 2023-08-30
• Study Completion: 2023-09-15
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-05
• Last Update Posted: 2024-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BMAC/bovine graft	BMAC loaded on bovine graft	Bone marrow aspirate concentrate loaded on bovine graft (Tutogen Medical GmbH, Neunkirchen am Brand, Germany, 1- 2mm particle size) utilization for sinus floor augmentation with residual alveolar bone height less than 5 mm, 1st arm
Bovine graft group	Bovine graft only	bovine graft utilization for sinus floor augmentation with residual alveolar bone height less than 5 mm, 2nd arm

Primary Outcome Measures

Name	Time	Method
Histological assessment	After 4 months of surgery	Histological assessment of core biopsy obtained at time of implant placement for percentage of new bone formation and residual graft

Secondary Outcome Measures

Name	Time	Method
Implant stability	After 4 months of surgery	implant stability immediately following installation after 4 months using ostell device (ISQ scale)
Bone gain	Preoperative, immediate and 4 months Postoperative	Vertical bone height gain from sinus floor on cone beam ct

Trial Locations

Locations (1)

Faculty of Dentistry, department of oral and Maxillofacial Surgery; 🇪🇬 Cairo, Egypt