Histological Assessment of BMAC Utilized in Sinus Lift

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)

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.

Study Overview

• Status: Completed
• Conditions: Implant Site Reaction
• Intervention / Treatment: Drug: BMAC loaded on bovine graft; Drug: Bovine graft only

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 Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 02
    • Faculty of Dentistry, department of oral and Maxillofacial Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: BMAC/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	Drug: BMAC loaded on bovine graft; Bone marrow aspirate concentrate loaded on bovine graft for sinus floor augmentation; Other Names: Bone marrow aspirate concentrate loaded on bovine graft
Active Comparator: Bovine graft group; bovine graft utilization for sinus floor augmentation with residual alveolar bone height less than 5 mm, 2nd arm	Drug: Bovine graft only; Bovine graft only for sinus floor augmentation; Other Names: Unloaded bovine graft

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Director: Maha Hakam, Phd, Professor at Faculty of Dentistry Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2022
• Primary Completion (Actual): August 30, 2023
• Study Completion (Actual): September 15, 2023

Study Registration Dates

• First Submitted: January 26, 2023
• First Submitted That Met QC Criteria: February 13, 2023
• First Posted (Actual): February 15, 2023

Study Record Updates

• Last Update Posted (Actual): February 6, 2024
• Last Update Submitted That Met QC Criteria: February 5, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Bone marrow; Sinus augmentation; Sinus lift
• Other Study ID Numbers: BMAC for sinus augmentation

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No