BMAC Loaded Collagen Jumping the Gap Around Immediate Implants

March 27, 2024 updated by: Walaa Kadry, Cairo University

Assessment of Collagen Loaded With Bone Marrow Aspirate Concentrate Versus Autograft on Marginal Bone Changes Around Immediate Implants in Esthetic Zone. A Randomized Controlled Clinical Trial

The present study aims to evaluate the effect of utilization of BMAC/ collagen on marginal bone changes around immediate implants in the esthetic zone of maxilla.

Methodology: Twenty dental implants will be installed in the esthetic zone and patients will be randomly divided into two groups:

study group: The jumping gap surrounding the immediate implants will be grafted with BMAC/collagen, whereas in the control group, autograft from the chin will be used to fill the defect. Cone beam CT (CBCT) will be requested Preoperative, immediate and 4 months Postoperative for assessment of marginal bone changes around implants.

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Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The aim of present study is to evaluate the effect of utilization of bone marrow aspirate concentrate (BMAC) loaded on collagen on the marginal bone changes around immediate implants in the esthetic zone of maxilla.

Methodology: Twenty dental implants will be installed in patients suffering from non- restorable teeth in esthetic zone.

Patients will be randomly divided into two equal groups:

study group: The jumping gap surrounding the immediate implants will be grafted with bone marrow aspirate concentrate loaded on collagen, whereas in the control group, autogenous bone graft from the chin will be used to fill the peri-implant defect. CBCT will be requested Preoperative, immediate and 4 months Postoperative for assessment of marginal bone changes around dental implants.

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Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Ahmed Amin

Study Locations

  • Egypt
      • Cairo, Egypt, 02
        • Recruiting
        • Walaa Kadry
        • Contact:
          • Wael Abdel samee

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Patients with non- restorable teeth in esthetic zone
  • Patients above 18 us
  • Highly motivated patients.

Exclusion Criteria:

  • patients with systemic diseases • immunocompromised patients . Patients with bleeding disorders

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: BMAC/ collagen
Bone marrow aspirate concentrate loaded on collagen utilization for filling peri-implant gap around immediate dental implants in the Maxillary esthetic zone
Drug: BMAC/ collagen
Bone marrow aspirate concentrate loaded on collagen in the peri-implant defect
Other Names:
  • Bone marrow aspirate concentrate group
Active Comparator: Autograft
Autograft harvested from chin utilization for filling peri-implant gap around immediate dental implants in the Maxillary esthetic zone
Procedure: Autograft harvesting from chin
Autograft
Other Names:
  • Autograft group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Marginal bone changes
Time Frame: 4 months
Buccal bone height
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Study Director: Eman Said, Lecturer at Faculty of Dentistry, Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 25, 2023

Primary Completion (Estimated)

October 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

April 5, 2023

First Submitted That Met QC Criteria

April 5, 2023

First Posted (Actual)

April 18, 2023

Study Record Updates

Last Update Posted (Actual)

March 28, 2024

Last Update Submitted That Met QC Criteria

March 27, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • BMAC around immediate implants

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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