Implant Site ReactionNCT05730400
Histological Assessment of BMAC Utilized in Sinus Lift
A study testing BMAC loaded on bovine graft and Bovine graft only in people with Implant Site Reaction, run by Cairo University at 1 site in Egypt.
Trial summary
Aim : The aim of present study was to evaluate BMAC/bovine graft utilization in Sinus membrane augmentation on bone quality and quantity. Methodology: sixteen patients suffering from atrophic posterior maxilla with sinus pneumatization were randomly divided into two equal groups: study group: the sinus membrane was… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Implant Site Reaction
- What is being tested?
- BMAC loaded on bovine graft and Bovine graft only
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Oct 2022to 15 Sep 2023
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with missing upper posterior teeth and atrophic posterior maxilla with a residual bone height ranging from 4 to 6 mm
- Patients who has as deficient as 4 mm vertical bone height in posterior maxilla that need bone augmentation before delayed implant placement.
- Highly motivated patients
Who cannot join
- Patients suffering from any systemic disease or those under any medication that may interfere with normal bone healing.
- Patients suffering from any sinus pathosis.
- Patients with conditions that could potentially compromise BM quality, previous BMA, or acute illness.
- Heavy smoker (> 20 cigarettes daily)
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Dentistry, department of oral and Maxillofacial Surgery
Cairo, 02
About this study
Official title: Histological Assessment of Deproteinized Bovine Bone Loaded by Bone Marrow Aspirate Versus Deproteinized Bovine Bone Alone for Guided Sinus Floor Elevation. (A Randomized Controlled Clinical Trial)
Aim : The aim of present study was to evaluate BMAC/bovine graft utilization in Sinus membrane augmentation on bone quality and quantity. Methodology: sixteen patients suffering from atrophic posterior maxilla with sinus pneumatization were randomly divided into two equal groups: study group: the sinus membrane was elevated with BMAC/bovine graft whereas the control group recieved bovine graft only for sinus floor augmentation.
All patients will be evaluated at 1 week, 4 months to measure bone height and bone core biopsy for histological assessment at 4 months during implant placement.
Read the detailed description
Aim : The aim of present study was to evaluate BMAC/bovine graft utilization in Sinus membrane augmentation on bone height gain and quality of bone on histological assessment.
Methodology: sixteen patients suffering from atrophic posterior maxilla with sinus pneumatization were randomly divided into two equal groups: study group: the sinus membrane was elevated with bone marrow aspirate concentrate loaded on bovine graft whereas the control group recieved bovine graft only for sinus floor augmentation.
All patients will be evaluated at 1 week, 4 months by CBCT to measure bone height and bone core biopsy for histological assessment at 4 months during implant placement.
- Conditions
- Implant Site Reaction
- Being tested
- BMAC loaded on bovine graft, Bovine graft only
- Keywords
- Bone marrow, Sinus augmentation, Sinus lift
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMAC loaded on bovine graftDrug
Also called Bone marrow aspirate concentrate loaded on bovine graft
Bone marrow aspirate concentrate loaded on bovine graft for sinus floor augmentation
Bovine graft onlyDrug
Also called Unloaded bovine graft
Bovine graft only for sinus floor augmentation
| Study group | Role | What they receive |
|---|---|---|
| BMAC/bovine graft | Active comparator | Bone marrow aspirate concentrate loaded on bovine graft (Tutogen Medical GmbH, Neunkirchen am Brand, Germany, 1- 2mm particle size) utilization for sinus floor augmentation with residual alveolar bone height less than 5 mm, 1st arm Receives: Drug: BMAC loaded on bovine graft |
| Bovine graft group | Active comparator | bovine graft utilization for sinus floor augmentation with residual alveolar bone height less than 5 mm, 2nd arm Receives: Drug: Bovine graft only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Histological assessment
Histological assessment of core biopsy obtained at time of implant placement for percentage of new bone formation and residual graft
Measured: After 4 months of surgery
Secondary outcomes (2)
Implant stability
implant stability immediately following installation after 4 months using ostell device (ISQ scale)
Measured: After 4 months of surgery
Bone gain
Vertical bone height gain from sinus floor on cone beam ct
Measured: Preoperative, immediate and 4 months Postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2023
- Study start30 Oct 2022
- Primary completion30 Aug 2023
- Study completion15 Sep 2023
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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Walaa Kadry, Cairo University
- Investigators
- Maha Hakam, Phd, Study director, Professor at Faculty of Dentistry Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05730400
- Sponsor's protocol ID
- BMAC for sinus augmentation
- Status last verified
- Feb 2024
- First submitted
- 26 Jan 2023
- Last updated
- 6 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Histological Assessment of Deproteinized Bovine Bone Loaded by Bone Marrow Aspirate Versus Deproteinized Bovine Bone Alone for Guided Sinus Floor Elevation. (A Randomized Controlled Clinical Trial)
- ClinicalTrials.gov ID
- NCT05730400
- Acronym / sponsor ID
- BMAC for sinus augmentation
- Conditions
- Implant Site Reaction
- Keywords
- Bone marrow, Sinus augmentation, Sinus lift
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 30 Oct 2022 (actual)
- Primary completion
- 30 Aug 2023 (actual)
- Study completion
- 15 Sep 2023 (actual)
- First posted
- 15 Feb 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.
Aim : The aim of present study was to evaluate BMAC/bovine graft utilization in Sinus membrane augmentation on bone quality and quantity. Methodology: sixteen patients suffering from atrophic posterior maxilla with sinus pneumatization were randomly divided into two equal groups: study group: the sinus membrane was elevated with BMAC/bovine graft whereas the control group recieved bovine graft only for sinus floor augmentation.
All patients will be evaluated at 1 week, 4 months to measure bone height and bone core biopsy for histological assessment at 4 months during implant placement.
Detailed description
Aim : The aim of present study was to evaluate BMAC/bovine graft utilization in Sinus membrane augmentation on bone height gain and quality of bone on histological assessment.
Methodology: sixteen patients suffering from atrophic posterior maxilla with sinus pneumatization were randomly divided into two equal groups: study group: the sinus membrane was elevated with bone marrow aspirate concentrate loaded on bovine graft whereas the control group recieved bovine graft only for sinus floor augmentation.
All patients will be evaluated at 1 week, 4 months by CBCT to measure bone height and bone core biopsy for histological assessment at 4 months during implant placement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BMAC/bovine graft | Active comparator | Drug: BMAC loaded on bovine graftBone marrow aspirate concentrate loaded on bovine graft (Tutogen Medical GmbH, Neunkirchen am Brand, Germany, 1- 2mm particle size) utilization for sinus floor augmentation with residual alveolar bone height less than 5 mm, 1st arm |
| Bovine graft group | Active comparator | Drug: Bovine graft onlybovine graft utilization for sinus floor augmentation with residual alveolar bone height less than 5 mm, 2nd arm |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with missing upper posterior teeth and atrophic posterior maxilla with a residual bone height ranging from 4 to 6 mm
- Patients who has as deficient as 4 mm vertical bone height in posterior maxilla that need bone augmentation before delayed implant placement.
- Highly motivated patients
Key exclusion criteria (4 listed)
- Patients suffering from any systemic disease or those under any medication that may interfere with normal bone healing.
- Patients suffering from any sinus pathosis.
- Patients with conditions that could potentially compromise BM quality, previous BMA, or acute illness.
- Heavy smoker (> 20 cigarettes daily)
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 loaded on bovine graftAlso: Bone marrow aspirate concentrate loaded on bovine graftBone marrow aspirate concentrate loaded on bovine graft for sinus floor augmentation | Drug | BMAC/bovine graft |
| Bovine graft onlyAlso: Unloaded bovine graftBovine graft only for sinus floor augmentation | Drug | Bovine graft group |
Primary outcome
Histological assessment
Time frame: After 4 months of surgery
Histological assessment of core biopsy obtained at time of implant placement for percentage of new bone formation and residual graft
2 secondary outcomes
Implant stability
Time frame: After 4 months of surgery
Bone gain
Time frame: Preoperative, immediate and 4 months Postoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 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.
Maha Hakam, Phd study director
Professor 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 loaded on bovine graft and Bovine graft only in people with Implant Site Reaction, 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 4 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: finished, as of the sponsor's last update on 6 Feb 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Histological assessment (time frame: After 4 months of surgery). 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 6 Feb 2024.