NCT05817526

Brief 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. .

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 25, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 5, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 18, 2023

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

March 28, 2024

Status Verified

March 1, 2024

Enrollment Period

1.7 years

First QC Date

April 5, 2023

Last Update Submit

March 27, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Marginal bone changes

    Buccal bone height

    4 months

Study Arms (2)

BMAC/ collagen

ACTIVE COMPARATOR

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

Autograft

ACTIVE COMPARATOR

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

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

Also known as: Bone marrow aspirate concentrate group
BMAC/ collagen

Autograft

Also known as: Autograft group
Autograft

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Walaa Kadry

Cairo, 02, Egypt

RECRUITING

MeSH Terms

Interventions

Collagen

Intervention Hierarchy (Ancestors)

BiopolymersPolymersMacromolecular SubstancesExtracellular Matrix ProteinsScleroproteinsProteinsAmino Acids, Peptides, and Proteins

Study Officials

  • Eman Said

    Lecturer at Faculty of Dentistry, Cairo University

    STUDY DIRECTOR

Central Study Contacts

Ahmed Amin

CONTACT

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

April 5, 2023

First Posted

April 18, 2023

Study Start

January 25, 2023

Primary Completion

October 1, 2024

Study Completion

December 1, 2024

Last Updated

March 28, 2024

Record last verified: 2024-03

Locations