Skip to main content
OpenTrials
Completed

NCT Number: NCT05730400

Histological Assessment of BMAC Utilized in Sinus Lift

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, department of oral and Maxillofacial Surgery

Cairo, 02, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

BMAC loaded on bovine graft

Drug

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

Other names: Bone marrow aspirate concentrate loaded on bovine graft

Bovine graft only

Drug

Bovine graft only for sinus floor augmentation

Other names: Unloaded bovine graft

Primary outcomes

  1. Histological assessment

    Time frame: 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 outcomes

  1. Implant stability

    Time frame: After 4 months of surgery

    implant stability immediately following installation after 4 months using ostell device (ISQ scale)

  2. Bone gain

    Time frame: Preoperative, immediate and 4 months Postoperative

    Vertical bone height gain from sinus floor on cone beam ct

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study 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)

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 15, 2023
Registry last updated
Feb 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.