BMAC Loaded Collagen Jumping the Gap Around Immediate Imp... | NCT05817526

Studies
BMAC Loaded Collagen Jumping the Gap Around Immediate Implants

NCT05817526

Sponsor

Cairo University

Status

Unknown status

Last Update Posted

Mar 28, 2024Actual

Enrollment

20Estimated

Phase

Not Applicable

Conditions

Implant Site Reaction
Dental Implantation

Interventions

BMAC/ collagen
Autograft harvesting from chin

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 25, 2023Actual

Primary Completion Date

Oct 2024Estimated

Completion Date

Dec 2024Estimated

First Submitted Date

Apr 5, 2023

First Submission Date that Met QC Criteria

Apr 5, 2023

First Posted Date

Apr 18, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 27, 2024

Last Update Posted Date

Mar 28, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Walaa Kadry, Lecturer of oral and Maxillofacial Surgery, Cairo UniversityPrincipal Investigator

Lead Sponsor

Cairo UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
BMAC/ collagen	Drug	Bone marrow aspirate concentrate loaded on collagen in the peri-implant defect	BMAC/ collagen

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Walaa Kadry	Contact	+201061527359		walaakadry@dentistry.cu.edu.eg
Ahmed Amin	Contact

Overall Officials

Name	Affiliation	Role
Eman Said	Lecturer at Faculty of Dentistry, Cairo University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Walaa Kadry	Recruiting	Cairo		02	Egypt

Intervention Browse Module

MeSH Terms

ID	Term
D003094	Collagen

Ancestor Terms

ID	Term
D001704	Biopolymers
D011108	Polymers
D046911	Macromolecular Substances
D016326	Extracellular Matrix Proteins

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