Maxillary Sinus LiftingNCT07177495
Radiographic and Histomorphometric Assessment for Maxillary Sinus Floor Elevation and Augmentation Using A Mixture of 1:1 Autogenous Bone With Deproteinized Bovine Bone Particulate Versus Deproteinized Bovine Bone Particulate
A study testing maxillary sinus floor elevation using Open Maxillary sinus floor elevation and Augmentation using Deproteinized Bovine Bone Particulate and Open Maxillary sinus floor elevation and Augmentation using A Mixture of 1:1 Autogenous Bone with Deproteinized Bovine Bone Particulate in people with Maxillary Sinus Lifting, run by Cairo University at 1 site in Egypt.
Trial summary
two group of patients with atrophied posterior maxilla that need implant/s placement. one group will be subjected to maxillary sinus floor elevation using 1:1 mixture of autogenous bone and deproteinized bovine bone particulate while the other will be subjected to maxillary sinus floor elevation using deproteinized… Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Maxillary Sinus Lifting
- What is being tested?
- maxillary sinus floor elevation using Open Maxillary sinus floor elevation and Augmentation using Deproteinized Bovine Bone Particulate and Open Maxillary sinus floor elevation and Augmentation using A Mixture of 1:1 Autogenous Bone with Deproteinized Bovine Bone Particulate
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Apr 2025to 10 Mar 2026
- Phase
- Interventional
- 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • Patients of both genders requiring implants placement in atrophied posterior maxilla with residual bone height less than 5mm .
- Patients of age older than 30 years old.
- Patients with adequate Inter-arch space.
- Patients who were willing and fully capable to comply with the study protocol.
Who cannot join
- • Patients suffering from any sinus pathosis
- Heavy smokers (> than 10 cigarettes a day)
- Patients with parafunctional habits
- Patients with uncontrolled systemic diseases.
- Patients with poor oral hygiene
- Patients with mental instabilities or psychic patients
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mohamed Atef abdelrasoul, PhD contact
Egypt1 site, 1 recruiting
- Recruiting
faculty of oral and dental medicine, Cairo university
Cairo, Giza Governorate, 12613
Merna H Abdelhamid, BSc, +201060969620 ext. +201060969620, merna-hamdy@dentistry.cu.edu.eg
Mohamed A Abdelrasoul, PhD, +201009612708 ext. +201009612708, Mohammedatef@dentistry.cu.edu.eg
About this study
Official title: Radiographic and Histomorphometric Assessment for Maxillary Sinus Floor Elevation and Augmentation Using A Mixture of 1:1 Autogenous Bone With Deproteinized Bovine Bone Particulate Versus Deproteinized Bovine Bone Particulate: A Randomized Clinical Trial
two group of patients with atrophied posterior maxilla that need implant/s placement. one group will be subjected to maxillary sinus floor elevation using 1:1 mixture of autogenous bone and deproteinized bovine bone particulate while the other will be subjected to maxillary sinus floor elevation using deproteinized bovine bone particulate alone.
Read the detailed description
- Preoperative imaging using CBCT will be performed to assess the anatomy of the maxillary sinus, including the presence of septa, the thickness of the sinus membrane, and the quality and quantity of bone available for grafting and to exlude the presence of any pathosis.
Phase 1 (concerning maxillary sinus floor elevation and Graft placement):
- All surgical procedures will be performed by a single experienced oral surgeon to minimize variability.
- All patients in the two groups would be operated under Local anaesthesia, a full-thickness mucoperiosteal flap originating from the midcrestal area or slightly toward the palate side would be opened.
- A lateral window will be created in the maxillary bone using, The window should be large enough to allow for adequate access to the sinus membrane.
- The Schneiderian membrane will be carefully elevated using a sinus elevator or similar instrument.
- Once the membrane is elevated, Depending on the allocation, graft material will be placed into the sinus cavity either using A mixture of 1:1 Autogenous Bone with Deproteinized Bovine Bone Particulate Versus Deproteinized Bovine Bone Particulate.
- a collagen membrane will be placed over the graft material. The membrane should be trimmed to fit the dimensions of the lateral window and secured in place using resorbable sutures or tacks if necessary.
- The mucoperiosteal flap will be repositioned and secured using sutures.
Phase 2 (delayed implant placement and core biopsy harvesting 6 Months Postoperative):
- A full thickness mucoperiosteal flap originating from the mid-crestal area or slightly towards palate side would be opened for both groups.
- A core biopsy would be harvested from both groups using trephine burs from the site of implant placement prior to drilling, to be sent to the Lab for Histological assessment.
The mucoperiosteal flap will be repositioned and secured using sutures
- Conditions
- Maxillary Sinus Lifting
- Being tested
- maxillary sinus floor elevation using Open Maxillary sinus floor elevation and Augmentation using Deproteinized Bovine Bone Particulate, Open Maxillary sinus floor elevation and Augmentation using A Mixture of 1:1 Autogenous Bone with Deproteinized Bovine Bone Particulate
- Keywords
- maxillary sinus lifting, deproteinized bovine bone particulate, autogenous bone graft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
maxillary sinus floor elevation using Open Maxillary sinus floor elevation and Augmentation using Deproteinized Bovine Bone ParticulateProcedure or surgery
Phase 1: Grafting
- after administration of Local anesthesia (articaine hydrochloride 68 mg/1.7 ml + adrenaline0.017 mg), full-thickness mucoperiosteal flap originating from the mid-crestal area or slightly toward the palate side would be opened.
- lateral window will be created in the maxillary bone to allow for adequate access to the sinus membrane.
- The membrane will be carefully elevated using a sinus elevator.
- bone graft will be placed into the sinus cavity using Autogenous Bone with Deproteinized Bovine Bone Particulate.
- collagen membrane will be secured in place using resorbable sutures or tacks if necessary.
Phase 2 (delayed implant placement and core biopsy harvesting 6 Months Postoperative):
- full thickness mucoperiosteal flap originating from the mid-crestal area or slightly towards palate side would be opened.
- core biopsy would be harvested using trephine burs from the site of implant placement prior to drilling, to be sent to the Lab for Histological assessment.
Open Maxillary sinus floor elevation and Augmentation using A Mixture of 1:1 Autogenous Bone with Deproteinized Bovine Bone ParticulateProcedure or surgery
Phase 1: Grafting
- After maxillary sinus floor elevation, Mixture of 1:1 Autogenous Bone with Deproteinized Bovine Bone Particulate will be placed in the sinus cavity and secured in place using resorbable sutures or tacks if necessary.
- Phase 2 (delayed implant placement and core biopsy harvesting 6 Months Postoperative):
- full thickness mucoperiosteal flap originating from the mid-crestal area or slightly towards palate side would be opened. • core biopsy would be harvested using trephine burs from the site of implant placement prior to drilling, to be sent to the Lab for Histological assessment.
| Study group | Role | What they receive |
|---|---|---|
| sinus floor elevation And Augmentation using Deproteinized Bovine Bone Particulate. | Active comparator | Not described Receives: Procedure: maxillary sinus floor elevation using Open Maxillary sinus floor elevation and Augmentation using Deproteinized Bovine Bone Particulate |
| Open Maxillary sinus floor elevation and Augmentation using A Mixture of 1:1 Autogenous Bone with De | Experimental | Not described Receives: Procedure: Open Maxillary sinus floor elevation and Augmentation using A Mixture of 1:1 Autogenous Bone with Deproteinized Bovine Bone Particulate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone Height Changes
measuring the amount of change in the bone height using cone beam computed tomography in millimeters.
Measured: 9 month
Secondary outcomes (1)
1. Bone Volume Changes
measuring the volumetric changes of bone using CBCT in Cm3
Measured: 9 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2025
- Study start10 Apr 2025
- Primary completion10 Feb 2026 (estimated)
- Study completion10 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maxillary Sinus LiftingStudies 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
- Participant
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, merna hamdy, Cairo University
- Investigators
- Mohamed Atef Abdelrasoul, PhD, Study director, faculty of oral and dental medicine, Cairo university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07177495
- Sponsor's protocol ID
- maxillary sinus lift
- Status last verified
- Sep 2025
- First submitted
- 10 Sep 2025
- Last updated
- 17 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiographic and Histomorphometric Assessment for Maxillary Sinus Floor Elevation and Augmentation Using A Mixture of 1:1 Autogenous Bone With Deproteinized Bovine Bone Particulate Versus Deproteinized Bovine Bone Particulate: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07177495
- Acronym / sponsor ID
- maxillary sinus lift
- Conditions
- Maxillary Sinus Lifting
- Keywords
- maxillary sinus lifting, deproteinized bovine bone particulate, autogenous bone graft
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 Apr 2025 (actual)
- Primary completion
- 10 Feb 2026 (estimated)
- Study completion
- 10 Mar 2026 (estimated)
- First posted
- 17 Sep 2025 (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 group of patients with atrophied posterior maxilla that need implant/s placement. one group will be subjected to maxillary sinus floor elevation using 1:1 mixture of autogenous bone and deproteinized bovine bone particulate while the other will be subjected to maxillary sinus floor elevation using deproteinized bovine bone particulate alone.
Detailed description
- Preoperative imaging using CBCT will be performed to assess the anatomy of the maxillary sinus, including the presence of septa, the thickness of the sinus membrane, and the quality and quantity of bone available for grafting and to exlude the presence of any pathosis.
Phase 1 (concerning maxillary sinus floor elevation and Graft placement):
- All surgical procedures will be performed by a single experienced oral surgeon to minimize variability.
- All patients in the two groups would be operated under Local anaesthesia, a full-thickness mucoperiosteal flap originating from the midcrestal area or slightly toward the palate side would be opened.
- A lateral window will be created in the maxillary bone using, The window should be large enough to allow for adequate access to the sinus membrane.
- The Schneiderian membrane will be carefully elevated using a sinus elevator or similar instrument.
- Once the membrane is elevated, Depending on the allocation, graft material will be placed into the sinus cavity either using A mixture of 1:1 Autogenous Bone with Deproteinized Bovine Bone Particulate Versus Deproteinized Bovine Bone Particulate.
- a collagen membrane will be placed over the graft material. The membrane should be trimmed to fit the dimensions of the lateral window and secured in place using resorbable sutures or tacks if necessary.
- The mucoperiosteal flap will be repositioned and secured using sutures.
Phase 2 (delayed implant placement and core biopsy harvesting 6 Months Postoperative):
- A full thickness mucoperiosteal flap originating from the mid-crestal area or slightly towards palate side would be opened for both groups.
- A core biopsy would be harvested from both groups using trephine burs from the site of implant placement prior to drilling, to be sent to the Lab for Histological assessment.
The mucoperiosteal flap will be repositioned and secured using sutures
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sinus floor elevation And Augmentation using Deproteinized Bovine Bone Particulate. | Active comparator | Procedure: maxillary sinus floor elevation using Open Maxillary sinus floor elevation and Augmentation using Deproteinized Bovine Bone Particulate |
| Open Maxillary sinus floor elevation and Augmentation using A Mixture of 1:1 Autogenous Bone with De | Experimental | Procedure: Open Maxillary sinus floor elevation and Augmentation using A Mixture of 1:1 Autogenous Bone with Deproteinized Bovine Bone Particulate |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- • Patients of both genders requiring implants placement in atrophied posterior maxilla with residual bone height less than 5mm .
Key exclusion criteria (6 listed)
- • Patients suffering from any sinus pathosis
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 |
|---|---|---|
| maxillary sinus floor elevation using Open Maxillary sinus floor elevation and Augmentation using Deproteinized Bovine Bone ParticulatePhase 1: Grafting * after administration of Local anesthesia (articaine hydrochloride 68 mg/1.7 ml + adrenaline0.017 mg), full-thickness mucoperiosteal flap originating from the mid-crestal area or slightly toward the palate side would be opened. * lateral window will be created in the maxillary bone to allow for adequate access to the sinus membrane. * The membrane will be carefully elevated using a sinus elevator. * bone graft will be placed into the sinus cavity using Autogenous Bone with Deproteinized Bovine Bone Particulate. * collagen membrane will be secured in place using resorbable sutures or tacks if necessary. Phase 2 (delayed implant placement and core biopsy harvesting 6 Months Postoperative): * full thickness mucoperiosteal flap originating from the mid-crestal area or slightly towards palate side would be opened. * core biopsy would be harvested using trephine burs from the site of implant placement prior to drilling, to be sent to the Lab for Histological assessment. | Procedure or surgery | sinus floor elevation And Augmentation using Deproteinized Bovine Bone Particulate. |
| Open Maxillary sinus floor elevation and Augmentation using A Mixture of 1:1 Autogenous Bone with Deproteinized Bovine Bone ParticulatePhase 1: Grafting * After maxillary sinus floor elevation, Mixture of 1:1 Autogenous Bone with Deproteinized Bovine Bone Particulate will be placed in the sinus cavity and secured in place using resorbable sutures or tacks if necessary. * Phase 2 (delayed implant placement and core biopsy harvesting 6 Months Postoperative): * full thickness mucoperiosteal flap originating from the mid-crestal area or slightly towards palate side would be opened. • core biopsy would be harvested using trephine burs from the site of implant placement prior to drilling, to be sent to the Lab for Histological assessment. | Procedure or surgery | Open Maxillary sinus floor elevation and Augmentation using A Mixture of 1:1 Autogenous Bone with De |
Primary outcome
Bone Height Changes
Time frame: 9 month
measuring the amount of change in the bone height using cone beam computed tomography in millimeters.
1 secondary outcome
1. Bone Volume Changes
Time frame: 9 month
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 17 Sep 2025.
- Individual participant dataSharing planned: No
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Two-Stage Transcrestal Sinus Lift With Osseodensification: Allograft vs Autogenous-Xenograft
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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.
Mohamed Atef abdelrasoul, PhD contact
Mohamed Atef Abdelrasoul, PhD study director
faculty of oral and dental medicine, 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 maxillary sinus floor elevation using Open Maxillary sinus floor elevation and Augmentation using Deproteinized Bovine Bone Particulate and Open Maxillary sinus floor elevation and Augmentation using A Mixture of 1:1 Autogenous Bone with Deproteinized Bovine Bone Particulate in people with Maxillary Sinus Lifting, 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 4 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 17 Sep 2025. 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?
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 Merna Hamdy Abdelhamid, BSc (+201060696920, Merna-hamdy@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone Height Changes (time frame: 9 month). 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 17 Sep 2025.