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RecruitingNCT05817526Updated Mar 28, 2024

BMAC Loaded Collagen Jumping the Gap Around Immediate Implants

An interventional study of BMAC/ collagen and Autograft harvesting from chin in Implant Site Reaction and Dental Implantation, sponsored by Cairo University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-28.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Oct 2024, 2 years ago, but the record still lists the study as recruiting.
  • Started Jan 2023; still recruiting 3 years 8 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study summary

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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Read the 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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02

Conditions studied

  • Implant Site Reaction
  • Dental Implantation
03

In context

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • patients with systemic diseases • immunocompromised patients . Patients with bleeding disorders
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
20 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • DrugBMAC/ collagen

    Bone marrow aspirate concentrate loaded on collagen in the peri-implant defect

    Also known as: Bone marrow aspirate concentrate group

  • ProcedureAutograft harvesting from chin

    Autograft

    Also known as: Autograft group

06

What researchers measure

Primary outcomes

  1. Marginal bone changes

    Buccal bone height

    Time frame: 4 months

07

Study locations

1 of 1 sites recruiting
  • Walaa Kadry
    Cairo, 02, Egypt
    • Wael Abdel samee · Contact
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 28, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05817526
Lead sponsor
Cairo University
Responsible party
Walaa Kadry (Lecturer of oral and Maxillofacial Surgery, Cairo University) — Principal investigator
First posted
Apr 18, 2023
Start date
Jan 25, 2023
Primary completion
Oct 2024 (estimated)
Completion
Dec 2024 (estimated)
Last update
Mar 28, 2024

Study contacts

Walaa Kadry
Contact
walaakadry@dentistry.cu.edu.eg
+201061527359
Ahmed Amin
Contact
Eman Said
study director · Lecturer at Faculty of Dentistry, Cairo University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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