Histological Assessment of BMAC Utilized in Sinus Lift

NCT ID: NCT05730400

Last Updated: 2024-02-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-30

Study Completion Date

2023-09-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Implant Site Reaction

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type ACTIVE_COMPARATOR

BMAC loaded on bovine graft

Intervention Type DRUG

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

Bovine graft group

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

Group Type ACTIVE_COMPARATOR

Bovine graft only

Intervention Type DRUG

Bovine graft only for sinus floor augmentation

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

BMAC loaded on bovine graft

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

Intervention Type DRUG

Bovine graft only

Bovine graft only for sinus floor augmentation

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Bone marrow aspirate concentrate loaded on bovine graft Unloaded bovine graft

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Cairo University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Walaa Kadry

Lecturer of oral and Maxillofacial Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Maha Hakam, Phd

Role: STUDY_DIRECTOR

Professor at Faculty of Dentistry Cairo University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Faculty of Dentistry, department of oral and Maxillofacial Surgery

Cairo, , Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

BMAC for sinus augmentation

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.