Histological Assessment of BMAC Utilized in Sinus Lift

NCT05730400 | Completed DMC

• 1 other identifier: BMAC for sinus augmentation
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Implant Site Reaction

Keywords

Bone marrow; Sinus augmentation; Sinus lift

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Implant stability

  After 4 months of surgery

• Bone gain

  Preoperative, immediate and 4 months Postoperative

Study Arms (2)

BMAC/bovine graft

ACTIVE COMPARATOR

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

Bovine graft group

ACTIVE COMPARATOR

bovine graft utilization for sinus floor augmentation with residual alveolar bone height less than 5 mm, 2nd arm

Drug: Bovine graft only

Interventions

BMAC loaded on bovine graft DRUG

Bone marrow aspirate concentrate loaded on bovine graft for sinus floor augmentation

Also known as: Bone marrow aspirate concentrate loaded on bovine graft

BMAC/bovine graft

Bovine graft only DRUG

Bovine graft only for sinus floor augmentation

Also known as: Unloaded bovine graft

Bovine graft group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry, department of oral and Maxillofacial Surgery

Cairo, 02, Egypt

Location

Study Officials

• Maha Hakam, Phd

  Professor at Faculty of Dentistry Cairo University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of oral and Maxillofacial Surgery

Study Record Dates

• First Submitted: January 26, 2023
• First Posted: February 15, 2023
• Study Start: October 30, 2022
• Primary Completion: August 30, 2023
• Study Completion: September 15, 2023
• Last Updated: February 6, 2024

Record last verified: 2024-02

Locations

EG (1)