Maxillary Sinus Floor ElevationNCT06073912
Implant Placement With Corticocancellous Bone Block vs Mineralized Plasmatic Matrix in Maxillary Sinus Lifting
A study testing Open sinus lifting, Collecting blood sample and Bone graft harvesting in people with Maxillary Sinus Floor Elevation, run by Cairo University.
Trial summary
Maxillary sinus floor elevation is a predictable and effective procedure for increasing the height of the residual bone in the posterior maxilla. The sinus lift procedure is basically performed using Conventional lateral sinus floor elevation (CLSFE) when RBH < 5 mm. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Maxillary Sinus Floor Elevation
- What is being tested?
- Open sinus lifting, Collecting blood sample and Bone graft harvesting
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2023to 1 Jun 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with edentulous vertically deficient posterior maxillary ridge with remaining alveolar ridge bone height <4=/ mm.
- Both males as well as females without any active periodontal disease.
- All patients are in a good health with no systemic, immunologic, or debilitating diseases that could affect normal bone healing.
- Patients are free from T.M.J troubles, abnormal oral habits such as bruxism.
- The edentulous ridges are covered with optimal thickness of mucoperiosteum with no signs of inflammation, ulceration or scar tissue.
- Remaining natural teeth have good periodontal tissue support and occlusion showed sufficient inter arch space for future prosthesis.
Who cannot join
- On the local level, patients with maxillary sinus diseases, former sinus surgery and unfavorable inter maxillary relationship will be excluded.
- General contraindications to implant surgery.
- Remaining ridges>5mm
- Subjected to irradiation in the head and neck area less than 1 year before implantation.
- Untreated periodontitis.
- Poor oral hygiene and motivation.
Show all 17Show fewer
- Pregnant or nursing.
- Substance abuse/smoking.
- Psychiatric problems or unrealistic expectations.
- Severe bruxism or clenching.
- Treated or under treatment with intravenous amino-bisphosphonates.
- Lack of opposite occluding dentition/prosthesis in the area intended for implant placement.
- Active infection, current or previous pathology or severe inflammation in the area intended for implant placement.
- Need of bone augmentation procedures at implant placement site.
- Unable to open mouth sufficiently to accommodate the surgical tooling.
- Patients participating in other studies, if the present protocol could not be properly followed.
- Referred only for implant placement or unable to attend a 1-year follow-up.
About this study
Official title: Simultaneous Implant Placement With Autogenous Corticocancellous Bone Block vs Mineralized Plasmatic Matrix in Maxillary Sinus Lifting (Randomized Clinical Trial)
Maxillary sinus floor elevation is a predictable and effective procedure for increasing the height of the residual bone in the posterior maxilla. The sinus lift procedure is basically performed using Conventional lateral sinus floor elevation (CLSFE) when RBH < 5 mm.
The use of autogenous corticocancellous bone block allows the simultaneous placement of an implant in the severely atrophic maxilla. Autogenous corticocancellous block will be applied in these patients to decrease the number of surgical interventions and the complications related to the surgery, without any additional risk, as well as to provide graft stabilization with the implant itself, using a mechanism similar to that of a screw and nut. Although the traditional application of sticky bone inside the sinus gives the benefit of moldable shaping and accurate fit into the recipient bony cavity which hardens and allows for implant osteotomy and installation with adequate implant stability. Limited comparative studies of both techniques had been introduced to the literature. This study is aimed to compare the quantity of bone gain after open sinus lift and augmentation using autogenous corticocancellous bone blocks from the chin area versus autogenous particulate mineralized plasmatic matrix (sticky bone) graft used as control group.
The primary outcome which is amount of bone gain will be measured and secondary stability of the implant.
Read the detailed description
After meeting the inclusion criteria, A preoperative digital panoramic radiograph with 1:1 magnification will be taken for each patient as a primary survey in order to exclude the presence of any lesions at the area of interest. A cone beam computed tomography (CBCT) scan will be done to measure the amount of the remaining alverolar bone height preoperatively.
The procedure will start in both groups with administration of general anesthesia or local anesthesia PSA Nerve block, infraorbital block and greater palatine will be administered using mepivacaine HCl (2%) with levonordefrin 1:20 000 (Scandonest 2%; Septodont, Saint- Maur-des-Fossés, France) injection to control pain and bleeding. Scrubbing and draping of the patient will be carried out in a standard fashion using betadine.
Both groups will have open sinus lifting with simultaneous implant placement with different augmentation techniques.
The inte group will have autogenous corticocancellous block graft, while the comparator group will have mineralized plasmatic matrix (sticky bone) graft.
Autogenous bone graft will be harvested in both groups from the chin area, corticocancellous block (intervention group) and particulate chips (comparator group).
Blood sample will be collected from the patient in both groups. Bone graft will be stabilized in place during the drilling procedure using a clamp\screws.
Lateral window will be closed in both groups using PRF membrane.
- Conditions
- Maxillary Sinus Floor Elevation
- Being tested
- Open sinus lifting, Collecting blood sample, Bone graft harvesting, Autogenous corticocancellous block graft, Mineralized plasmatic matrix graft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open sinus liftingProcedure or surgery
Sinus lateral window to graft the floor of the sinus using sinus red diamond stone
Collecting blood sampleProcedure or surgery
Blood sample is collected to harvest PRP and PRF
Bone graft harvestingProcedure or surgery
Bone graft harvesting from the chin area
Autogenous corticocancellous block graftProcedure or surgery
Simultaneous implant placement with sinus lifting and grafting using autogenous corticocancellous block, stabilized inside the sinus using clamp or screws that will be removed before closure
Mineralized plasmatic matrix graftProcedure or surgery
Simultaneous implant placement with sinus lifting and grafting using mineralized plasmatic matrix that is formed using PRP of the patient mixed with particulate autogenous graft from the chin area
CentrifugeDevice
Centrifuge will be needed to get the PRP in the Comparator group and PRP in both groups
ACM burDevice
Auto Chip Maker will be used to collect the autogenous particulate bone graft for the sticky bone graft
| Study group | Role | What they receive |
|---|---|---|
| Autogenous corticocancellous block | Experimental | Autogenous bone graft harvested as a block from the chin area Receives: Procedure: Open sinus lifting; Procedure: Collecting blood sample; Procedure: Bone graft harvesting; Procedure: Autogenous corticocancellous block graft; Device: Centrifuge |
| Mineralized plasmatic matrix | Active comparator | Mix of patient's PRP and autogenous particulate graft Receives: Procedure: Open sinus lifting; Procedure: Collecting blood sample; Procedure: Bone graft harvesting; Procedure: Mineralized plasmatic matrix graft; Device: Centrifuge; Device: ACM bur |
What is being measured
The primary outcome is the main question the study is designed to answer.
bone width and height gain
Bone width and height in millimeter using CBCT
Measured: 4 months
Secondary outcomes (1)
ISQ (Implant Stability Quotients) score secondary implant stability
ISQ using ostell device ( scale from 0-100)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start1 Dec 2023 (estimated)
- Primary completion1 Apr 2024 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maxillary 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Abdel Salam Ibrahim Omara, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06073912
- Sponsor's protocol ID
- 12323
- Status last verified
- Oct 2023
- First submitted
- 14 Aug 2023
- Last updated
- 10 Oct 2023
- 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 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simultaneous Implant Placement With Autogenous Corticocancellous Bone Block vs Mineralized Plasmatic Matrix in Maxillary Sinus Lifting (Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT06073912
- Acronym / sponsor ID
- 12323
- Conditions
- Maxillary Sinus Floor Elevation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (estimated)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 10 Oct 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.
Maxillary sinus floor elevation is a predictable and effective procedure for increasing the height of the residual bone in the posterior maxilla. The sinus lift procedure is basically performed using Conventional lateral sinus floor elevation (CLSFE) when RBH < 5 mm.
The use of autogenous corticocancellous bone block allows the simultaneous placement of an implant in the severely atrophic maxilla. Autogenous corticocancellous block will be applied in these patients to decrease the number of surgical interventions and the complications related to the surgery, without any additional risk, as well as to provide graft stabilization with the implant itself, using a mechanism similar to that of a screw and nut. Although the traditional application of sticky bone inside the sinus gives the benefit of moldable shaping and accurate fit into the recipient bony cavity which hardens and allows for implant osteotomy and installation with adequate implant stability. Limited comparative studies of both techniques had been introduced to the literature. This study is aimed to compare the quantity of bone gain after open sinus lift and augmentation using autogenous corticocancellous bone blocks from the chin area versus autogenous particulate mineralized plasmatic matrix (sticky bone) graft used as control group.
The primary outcome which is amount of bone gain will be measured and secondary stability of the implant.
Detailed description
After meeting the inclusion criteria, A preoperative digital panoramic radiograph with 1:1 magnification will be taken for each patient as a primary survey in order to exclude the presence of any lesions at the area of interest. A cone beam computed tomography (CBCT) scan will be done to measure the amount of the remaining alverolar bone height preoperatively.
The procedure will start in both groups with administration of general anesthesia or local anesthesia PSA Nerve block, infraorbital block and greater palatine will be administered using mepivacaine HCl (2%) with levonordefrin 1:20 000 (Scandonest 2%; Septodont, Saint- Maur-des-Fossés, France) injection to control pain and bleeding. Scrubbing and draping of the patient will be carried out in a standard fashion using betadine.
Both groups will have open sinus lifting with simultaneous implant placement with different augmentation techniques.
The inte group will have autogenous corticocancellous block graft, while the comparator group will have mineralized plasmatic matrix (sticky bone) graft.
Autogenous bone graft will be harvested in both groups from the chin area, corticocancellous block (intervention group) and particulate chips (comparator group).
Blood sample will be collected from the patient in both groups. Bone graft will be stabilized in place during the drilling procedure using a clamp\screws.
Lateral window will be closed in both groups using PRF membrane.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Autogenous corticocancellous block | Experimental | Procedure: Open sinus lifting, Procedure: Collecting blood sample, Procedure: Bone graft harvesting, Procedure: Autogenous corticocancellous block graft, Device: CentrifugeAutogenous bone graft harvested as a block from the chin area |
| Mineralized plasmatic matrix | Active comparator | Procedure: Open sinus lifting, Procedure: Collecting blood sample, Procedure: Bone graft harvesting, Procedure: Mineralized plasmatic matrix graft, Device: Centrifuge, Device: ACM burMix of patient's PRP and autogenous particulate graft |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with edentulous vertically deficient posterior maxillary ridge with remaining alveolar ridge bone height <4=/ mm.
- Both males as well as females without any active periodontal disease.
- All patients are in a good health with no systemic, immunologic, or debilitating diseases that could affect normal bone healing.
- Patients are free from T.M.J troubles, abnormal oral habits such as bruxism.
- The edentulous ridges are covered with optimal thickness of mucoperiosteum with no signs of inflammation, ulceration or scar tissue.
Key exclusion criteria (17 listed)
- On the local level, patients with maxillary sinus diseases, former sinus surgery and unfavorable inter maxillary relationship will be excluded.
- General contraindications to implant surgery.
- Remaining ridges>5mm
- Subjected to irradiation in the head and neck area less than 1 year before implantation.
- Untreated periodontitis.
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 |
|---|---|---|
| Open sinus liftingSinus lateral window to graft the floor of the sinus using sinus red diamond stone | Procedure or surgery | Autogenous corticocancellous block, Mineralized plasmatic matrix |
| Collecting blood sampleBlood sample is collected to harvest PRP and PRF | Procedure or surgery | Autogenous corticocancellous block, Mineralized plasmatic matrix |
| Bone graft harvestingBone graft harvesting from the chin area | Procedure or surgery | Autogenous corticocancellous block, Mineralized plasmatic matrix |
| Autogenous corticocancellous block graftSimultaneous implant placement with sinus lifting and grafting using autogenous corticocancellous block, stabilized inside the sinus using clamp or screws that will be removed before closure | Procedure or surgery | Autogenous corticocancellous block |
| Mineralized plasmatic matrix graftSimultaneous implant placement with sinus lifting and grafting using mineralized plasmatic matrix that is formed using PRP of the patient mixed with particulate autogenous graft from the chin area | Procedure or surgery | Mineralized plasmatic matrix |
| CentrifugeCentrifuge will be needed to get the PRP in the Comparator group and PRP in both groups | Device | Autogenous corticocancellous block, Mineralized plasmatic matrix |
| ACM burAuto Chip Maker will be used to collect the autogenous particulate bone graft for the sticky bone graft | Device | Mineralized plasmatic matrix |
Primary outcome
bone width and height gain
Time frame: 4 months
Bone width and height in millimeter using CBCT
1 secondary outcome
ISQ (Implant Stability Quotients) score secondary implant stability
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
Related trials for Maxillary Sinus Floor Elevation
Recruiting
The Application of a Biphasic Calcium Sulfate Graft Material in Sinus Floor Elevation
Alveolar Bone Loss, Edentulism Nos
Recruiting
Using Chin Bone Rings for Sinus Lifting and Dental Implants in One Surgery
Maxillary Deficiency, Bone Resorption
RecruitingPhase 2/3
Assessment of a New Enhanced Xenograft in Open Maxillary Sinus Augmentation
Maxillary Sinus Floor Augmentation, Maxillary Sinus Elevation
Recruiting
Evaluation of Lateral Sinus Floor Elevation Using Xenograft Versus L-PRF Block Combined With Xenograft
Sinus Floor Augmentation, Maxillary Sinus Floor Elevation
RecruitingObservational study
Impact of Alveolar Ridge Preservation on the Potential Need for Sinus Floor Elevation: A 10-year Retrospective Radiographical Study
Alveolar Bone Loss, Sinus Floor Augmentation
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Open sinus lifting, Collecting blood sample and Bone graft harvesting in people with Maxillary Sinus Floor Elevation, run by Cairo University.
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 6 inclusion and 17 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 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
bone width and height gain (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 10 Oct 2023.