Histological Assessment of BMAC Utilized in Sinus Lift

Implant Site Reaction Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05730400
• Other study ID #: BMAC for sinus augmentation
• Status: Completed
• Phase: N/A
• 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
• 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)

Related Conditions & MeSH terms

• Implant Site Reaction

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