Implant Site ReactionNCT05817526
BMAC Loaded Collagen Jumping the Gap Around Immediate Implants
A study testing BMAC/ collagen and Autograft harvesting from chin in people with Implant Site Reaction and Dental Implantation, run by Cairo University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Implant Site Reaction, Dental Implantation
- What is being tested?
- BMAC/ collagen and Autograft harvesting from chin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Jan 2023to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients with non- restorable teeth in esthetic zone
- Patients above 18 us
- Highly motivated patients.
Who cannot join
- patients with systemic diseases • immunocompromised patients . Patients with bleeding disorders
Trial locations and contacts
1 site in 1 country.
Ahmed Amin contact
About this study
Official title: 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.
.
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.
.
- Conditions
- Implant Site Reaction, Dental Implantation
- Being tested
- BMAC/ collagen, Autograft harvesting from chin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMAC/ collagenDrug
Also called Bone marrow aspirate concentrate group
Bone marrow aspirate concentrate loaded on collagen in the peri-implant defect
Autograft harvesting from chinProcedure or surgery
Also called Autograft group
Autograft
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Procedure: Autograft harvesting from chin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Marginal bone changes
Buccal bone height
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start25 Jan 2023
- Primary completionOct 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Implant Site ReactionStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Walaa Kadry, Cairo University
- Investigators
- Eman Said, Study director, Lecturer at Faculty of Dentistry, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05817526
- Sponsor's protocol ID
- BMAC around immediate implants
- Status last verified
- Mar 2024
- First submitted
- 5 Apr 2023
- Last updated
- 28 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05817526
- Acronym / sponsor ID
- BMAC around immediate implants
- Conditions
- Implant Site Reaction, Dental Implantation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 25 Jan 2023 (actual)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 18 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BMAC/ collagen | Active comparator | Drug: BMAC/ collagenBone marrow aspirate concentrate loaded on collagen utilization for filling peri-implant gap around immediate dental implants in the Maxillary esthetic zone |
| Autograft | Active comparator | Procedure: Autograft harvesting from chinAutograft harvested from chin utilization for filling peri-implant gap around immediate dental implants in the Maxillary esthetic zone |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients with non- restorable teeth in esthetic zone
- Patients above 18 us
- Highly motivated patients.
Key exclusion criteria (1 listed)
- patients with systemic diseases • immunocompromised patients . Patients with bleeding disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BMAC/ collagenAlso: Bone marrow aspirate concentrate groupBone marrow aspirate concentrate loaded on collagen in the peri-implant defect | Drug | BMAC/ collagen |
| Autograft harvesting from chinAlso: Autograft groupAutograft | Procedure or surgery | Autograft |
Primary outcome
Marginal bone changes
Time frame: 4 months
Buccal bone height
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed Amin contact
Eman Said study director
Lecturer at Faculty of Dentistry, Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BMAC/ collagen and Autograft harvesting from chin in people with Implant Site Reaction and Dental Implantation, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Walaa Kadry (+201061527359, walaakadry@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Marginal bone changes (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2024.