Sinus Floor ElevationPhase 1NCT06700772
Histomorphometric and Radiographic Evaluation of Bone Following Maxillary Sinus Augmentation
A Phase 1 study testing mixing bone marrow aspirate concentrate from maxillary tuberosity with bovine bone and mixing autogenous bone with bovine bone in people with Sinus Floor Elevation, run by Cairo University at 2 sites in Egypt.
Trial summary
Two groups of patients with posterior vertical deficient maxillary alveolar ridge with pneumatized sinus and needing dental implant . First group will be subjected to open sinus lifting using autogenous bone mixed with bone marrow aspirate concentrate cells from maxillary tuberosity and the second group will be… Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Sinus Floor Elevation
- What is being tested?
- mixing bone marrow aspirate concentrate from maxillary tuberosity with bovine bone and mixing autogenous bone with bovine bone
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Dec 2024to 1 Dec 2025
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with missing maxillary teeth with pneumatized sinus and remaining bone height <5mm
- Patients with healthy systemic condition (Medically free)
- Adequate inter-arch space for placement of the implant prosthetic part.
- Good oral hygiene
- Cooperative patients who are willing to commit for 6 months follow up
Who cannot join
- Smokers
- Pregnant females
- Patient with medical condition that contraindicates surgical procedures.
- Patients on medication that may interfere with healing (corticosteroids, bisphosphonate, Chemo/radio therapy).
- Patients with habits that may jeopardize the implant longevity and affect the results of the study such as alcoholism or parafunctional habits.
- Patients have chronic sinus disease.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt2 sites, 2 recruiting
- Recruiting
Faculty of oral and dental medicine - cairo university
Cairo, New Cairo, 12613
Alaa Hassan, BSc, 01026980299, Alaa.abdullah@dentistry.cu.edu.eg
Mohamed Mounir shaker, PhD, 01001505798, Mohamed.mounir@dentistry.cu.edu.eg
- Recruiting
Faculty of oral and dental medicine - cairo university
Cairo, 12613
Alaa Hassan, BSc, 01026980299, Alaa.abdullah@dentistry.cu.edu.eg
Mohammed Mounir shaker, PhD, 01001505798, Mohamed.mounir@dentistry.cu.edu.eg
About this study
Official title: Histomorphometric and Radiographic Assessment of Bone Following Maxillary Sinus Augmentation Using Bone Marrow Concentrate Cells From the Maxillary Tuberosity Mixed With Bovine Bone Versus Autogenous Bone Mixed With Bovine Bone: RCT
Two groups of patients with posterior vertical deficient maxillary alveolar ridge with pneumatized sinus and needing dental implant . First group will be subjected to open sinus lifting using autogenous bone mixed with bone marrow aspirate concentrate cells from maxillary tuberosity and the second group will be subjected to open sinus lifting using autogenous bone mixed with bovine bone
Read the detailed description
Two groups of patients with partial edentulous posterior maxilla with pneumatized sinus and need dental implant. First group will be subjected to open sinus lifting using autogenous bone mixed with bone marrow aspirate concentrate cells from maxillary tuberosity (the study group) and the second group will be subjected to open sinus lifting using autogenous bone mixed with bovine bone (control group) Intervention Eligible patients will be equally randomized in a parallel two arm groups . The study group (open sinus lifting using bone marrow aspirate concentrate from maxillary tuberosity mixed with bovine bone) Procedure will be performed under local anesthesia A 20 gauge needle will be inserted in the maxillary tuberosity area through the palatal aspect until aspiration is positive.
Aspirate will be collected in a heparin-treated tube (2000:1) using 1ml of anticoagulant acid citrate dextrose solution for every 15ml of bone marrow aspiration.
Aspirate will be centrifuged at 3000 rpm for 10 minutes to separate the BMAC . The upper layer containing plasma and platelets will be collected using a sterile pipette, leaving the bone marrow aspirate bone marrow aspirate will be mixed with bovine bone and then the mixture will be applied in open sinus lifting Control group (open sinus lifting using autogenous bone from retromolar area mixed with bovine bone) After injection of local anesthesia a crestal incision will be carried out from a point corresponding to the occlusal surface along the external oblique ridge and extending anteriorly and inferiorly through the buccal mucosa, parallel to the gingival margin of the mandibular molars.
The subperiosteal dissection will be extended to expose the ascending ramus and the retromolar region.
Auto chip maker bur will be used to drill out some autogenous bone particulate from retromolar which will be mixed with xenogeneic graft with a 50% to 50% ratio respectively. this mixture will be packed into the grafted site .
Post operative instructions and follow up:
Administration of:
- Antibiotics (Amoxicillin 1g twice daily for 5 days) to prevent any chance of infection.
- Anti-inflammatory drugs (NSAIDS; Ibuprofen 600mg three times daily for 5 days) to avoid any chance of edema or pain or swelling
- Antiseptic mouth rinse (0.12% Chlorhexidine oral rinse will be prescribed for 60 seconds two times a day for 14 days.
- The patient will be instructed to follow up for the next months before implant placement
Patient self-care instructions:
- Application of an ice bag to the treated area for the first 24 hours.
- Avoid any brushing and trauma to the surgical site for one week
- avoid smoking
- The patient will be asked to keep on clear fluid diet for the first 24 hours then a soft diet to be maintained for the next day.
- Strict oral hygiene measures in the form of regular use of toothbrush and antiseptic mouthwash starting week after surgery. Warm saline oral rinsing three times daily for one week.
Postsurgical procedure (six months lateral sinus lifting) Local anaesthesia will be administered by infiltration or nerve block to achieve the necessary anaesthesia.
A flap will be raised at the presurgical site. A core biopsy will be harvested by introducing a core drill bit in place of an initial drill.
Sequential drilling will take place to prepare osteotomy to the right size to receive an implant.
Implant will be placed in the osteotomy with the platform flush with the bone. Flap closure will be achieved by interrupted 5-0 sutures. Outcomes Primary outcome quantity of bone gain Secondary outcome quality of bone gain
- Conditions
- Sinus Floor Elevation
- Being tested
- mixing bone marrow aspirate concentrate from maxillary tuberosity with bovine bone, mixing autogenous bone with bovine bone
- Keywords
- Bone replacement materials, Bone substitutes, Maxillary sinus augmentation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mixing bone marrow aspirate concentrate from maxillary tuberosity with bovine boneProcedure or surgery
open sinus lifting using bone marrow aspirate concentrate from maxillary tuberosity and mixing it with bovine bone .
mixing autogenous bone with bovine boneProcedure or surgery
open sinus lifting using autogenous bone from retromolar area mixed with bovine bone
| Study group | Role | What they receive |
|---|---|---|
| open sinus lifting using bone marrow aspirate from maxillary tuberosity mixed with bovine bone | Experimental | Under local anesthesia a 20 gauge needle that will be inserted inside tuberosity until aspiration is positive and then the aspirate will be collected in heparin treated tube (1ml anticoagulant citrate dextrose) for each 15 ml of aspirate The aspirate will be centrifuged at 3000 rpm for 10 minutes to separate the BMAC The upper layer containing the plasma and platelet will be separated using sterile peptide tube leaving the BMAC Mixing BMAC with bovine bone (2cc of bio-oss) and it will be applied in grafted sinus Receives: Procedure: mixing bone marrow aspirate concentrate from maxillary tuberosity with bovine bone |
| Open sinus lifting using autogenous bone mixed with bovine bone | Active comparator | After injection of local anesthesia a crystal incision will be done from a point corresponding to occlusal surface along external oblique ridge and extending anteriorly and inferiorly through the buccal mucosa Subperiosteal dissection will be done to expose the retromolar area ACM bur will be used to collect autogenous bone and mixing it with bovine bone 50 : 50 Then this mixture will be packed into the grafted area Receives: Procedure: mixing autogenous bone with bovine bone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic assessment
Calculation of vertical bone gain quantity using cone beam computed tomography
Measured: 6 months postoperative
Secondary outcomes (1)
Histomorphometric analysis
Assessment of bone quality after open sinus lifting this bone will be harvested using trephine bur .and bone analysis will be done using H\&E stain by microscope
Measured: 6 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2024
- Study start1 Dec 2024 (estimated)
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sinus Floor ElevationStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A Randomized clinical trial A trial will be conducted in hospital of oral and maxillofacial surgery department.faculty of oral and dental medicine Cairo university Equal randomization of participant Both groups receiving treatment Each group of patient receiving a single treatment simultaneously
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Megahed Hassan Abdullah, Cairo University
- Investigators
- Mohammed Mounir shaker, Study director, Faculty of oral and dental medicine cairo university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06700772
- Sponsor's protocol ID
- CEBD-CU-12-5-2024
- Status last verified
- Nov 2024
- First submitted
- 16 Nov 2024
- Last updated
- 22 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Histomorphometric and Radiographic Assessment of Bone Following Maxillary Sinus Augmentation Using Bone Marrow Concentrate Cells From the Maxillary Tuberosity Mixed With Bovine Bone Versus Autogenous Bone Mixed With Bovine Bone: RCT
- ClinicalTrials.gov ID
- NCT06700772
- Acronym / sponsor ID
- CEBD-CU-12-5-2024
- Conditions
- Sinus Floor Elevation
- Keywords
- Bone replacement materials, Bone substitutes, Maxillary sinus augmentation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 22 Nov 2024 (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.
Two groups of patients with posterior vertical deficient maxillary alveolar ridge with pneumatized sinus and needing dental implant . First group will be subjected to open sinus lifting using autogenous bone mixed with bone marrow aspirate concentrate cells from maxillary tuberosity and the second group will be subjected to open sinus lifting using autogenous bone mixed with bovine bone
Detailed description
Two groups of patients with partial edentulous posterior maxilla with pneumatized sinus and need dental implant. First group will be subjected to open sinus lifting using autogenous bone mixed with bone marrow aspirate concentrate cells from maxillary tuberosity (the study group) and the second group will be subjected to open sinus lifting using autogenous bone mixed with bovine bone (control group) Intervention Eligible patients will be equally randomized in a parallel two arm groups . The study group (open sinus lifting using bone marrow aspirate concentrate from maxillary tuberosity mixed with bovine bone) Procedure will be performed under local anesthesia A 20 gauge needle will be inserted in the maxillary tuberosity area through the palatal aspect until aspiration is positive.
Aspirate will be collected in a heparin-treated tube (2000:1) using 1ml of anticoagulant acid citrate dextrose solution for every 15ml of bone marrow aspiration.
Aspirate will be centrifuged at 3000 rpm for 10 minutes to separate the BMAC . The upper layer containing plasma and platelets will be collected using a sterile pipette, leaving the bone marrow aspirate bone marrow aspirate will be mixed with bovine bone and then the mixture will be applied in open sinus lifting Control group (open sinus lifting using autogenous bone from retromolar area mixed with bovine bone) After injection of local anesthesia a crestal incision will be carried out from a point corresponding to the occlusal surface along the external oblique ridge and extending anteriorly and inferiorly through the buccal mucosa, parallel to the gingival margin of the mandibular molars.
The subperiosteal dissection will be extended to expose the ascending ramus and the retromolar region.
Auto chip maker bur will be used to drill out some autogenous bone particulate from retromolar which will be mixed with xenogeneic graft with a 50% to 50% ratio respectively. this mixture will be packed into the grafted site .
Post operative instructions and follow up:
Administration of:
- Antibiotics (Amoxicillin 1g twice daily for 5 days) to prevent any chance of infection.
- Anti-inflammatory drugs (NSAIDS; Ibuprofen 600mg three times daily for 5 days) to avoid any chance of edema or pain or swelling
- Antiseptic mouth rinse (0.12% Chlorhexidine oral rinse will be prescribed for 60 seconds two times a day for 14 days.
- The patient will be instructed to follow up for the next months before implant placement
Patient self-care instructions:
- Application of an ice bag to the treated area for the first 24 hours.
- Avoid any brushing and trauma to the surgical site for one week
- avoid smoking
- The patient will be asked to keep on clear fluid diet for the first 24 hours then a soft diet to be maintained for the next day.
- Strict oral hygiene measures in the form of regular use of toothbrush and antiseptic mouthwash starting week after surgery. Warm saline oral rinsing three times daily for one week.
Postsurgical procedure (six months lateral sinus lifting) Local anaesthesia will be administered by infiltration or nerve block to achieve the necessary anaesthesia.
A flap will be raised at the presurgical site. A core biopsy will be harvested by introducing a core drill bit in place of an initial drill.
Sequential drilling will take place to prepare osteotomy to the right size to receive an implant.
Implant will be placed in the osteotomy with the platform flush with the bone. Flap closure will be achieved by interrupted 5-0 sutures. Outcomes Primary outcome quantity of bone gain Secondary outcome quality of bone gain
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A Randomized clinical trial A trial will be conducted in hospital of oral and maxillofacial surgery department.faculty of oral and dental medicine Cairo university Equal randomization of participant Both groups receiving treatment Each group of patient receiving a single treatment simultaneously
| Arm | Type | Receives |
|---|---|---|
| open sinus lifting using bone marrow aspirate from maxillary tuberosity mixed with bovine bone | Experimental | Procedure: mixing bone marrow aspirate concentrate from maxillary tuberosity with bovine boneUnder local anesthesia a 20 gauge needle that will be inserted inside tuberosity until aspiration is positive and then the aspirate will be collected in heparin treated tube (1ml anticoagulant citrate dextrose) for each 15 ml of aspirate The aspirate will be centrifuged at 3000 rpm for 10 minutes to separate the BMAC The upper layer containing the plasma and platelet will be separated using sterile peptide tube leaving the BMAC Mixing BMAC with bovine bone (2cc of bio-oss) and it will be applied in grafted sinus |
| Open sinus lifting using autogenous bone mixed with bovine bone | Active comparator | Procedure: mixing autogenous bone with bovine boneAfter injection of local anesthesia a crystal incision will be done from a point corresponding to occlusal surface along external oblique ridge and extending anteriorly and inferiorly through the buccal mucosa Subperiosteal dissection will be done to expose the retromolar area ACM bur will be used to collect autogenous bone and mixing it with bovine bone 50 : 50 Then this mixture will be packed into the grafted area |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients with missing maxillary teeth with pneumatized sinus and remaining bone height <5mm
- Patients with healthy systemic condition (Medically free)
- Adequate inter-arch space for placement of the implant prosthetic part.
- Good oral hygiene
- Cooperative patients who are willing to commit for 6 months follow up
Key exclusion criteria (6 listed)
- Smokers
- Pregnant females
- Patient with medical condition that contraindicates surgical procedures.
- Patients on medication that may interfere with healing (corticosteroids, bisphosphonate, Chemo/radio therapy).
- Patients with habits that may jeopardize the implant longevity and affect the results of the study such as alcoholism or parafunctional habits.
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 |
|---|---|---|
| mixing bone marrow aspirate concentrate from maxillary tuberosity with bovine boneopen sinus lifting using bone marrow aspirate concentrate from maxillary tuberosity and mixing it with bovine bone . | Procedure or surgery | open sinus lifting using bone marrow aspirate from maxillary tuberosity mixed with bovine bone |
| mixing autogenous bone with bovine boneopen sinus lifting using autogenous bone from retromolar area mixed with bovine bone | Procedure or surgery | Open sinus lifting using autogenous bone mixed with bovine bone |
Primary outcome
Radiographic assessment
Time frame: 6 months postoperative
Calculation of vertical bone gain quantity using cone beam computed tomography
1 secondary outcome
Histomorphometric analysis
Time frame: 6 months postoperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2024.
- Human maxillary tuberosity and jaw periosteum as sources of osteoprogenitor cells for tissue engineering.Link provided by the sponsor.
- Stem cells in dentistry--part I: stem cell sources.Link provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Sinus Floor Elevation
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Assessment of a New Enhanced Xenograft in Open Maxillary Sinus Augmentation
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Clinical, Radiographic, Histological, and Patient-reported/ Experience Outcome Measures of Endoscopically-monitored Graftless Transcrestal Sinus Floor Elevation With Simultaneous Multiple Implant Placement Using Osseodensification(OD) Versus Osteotomes (OT) in Subsinus Bone Height of 4-5 mm: An RCT
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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.
Mohammed Mounir shaker study director
Faculty of oral and dental medicine cairo university
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing mixing bone marrow aspirate concentrate from maxillary tuberosity with bovine bone and mixing autogenous bone with bovine bone in people with Sinus Floor Elevation, run by Cairo University at 2 sites 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 5 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 22 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alaa Hassan, BSc (01026980299, Alaa.abdullah@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiographic assessment (time frame: 6 months postoperative). 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 22 Nov 2024.