Posterior Maxillary AtrophySINUS-GRAFTNCT07407361
Comparison of Allograft, Xenograft and Combined Grafting in Maxillary Sinus Augmentation
A study testing Lateral Maxillary Sinus Augmentation with Allograft, Lateral Maxillary Sinus Augmentation with Xenograft and Lateral Maxillary Sinus Augmentation with Combined Graft in people with Posterior Maxillary Atrophy and Maxillary Sinus Augmentation, run by Tokat Gaziosmanpasa University at 1 site in Turkey (Türkiye).
Trial summary
This prospective randomized clinical study evaluates and compares three different grafting approaches (allograft, xenograft, and combined grafting) used in lateral maxillary sinus augmentation prior to dental implant placement. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Posterior Maxillary Atrophy, Maxillary Sinus Augmentation
- What is being tested?
- Lateral Maxillary Sinus Augmentation with Allograft, Lateral Maxillary Sinus Augmentation with Xenograft and Lateral Maxillary Sinus Augmentation with Combined Graft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Jun 2022to 24 Apr 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 to 75 years.
- Patients presenting with posterior maxillary edentulism requiring dental implant rehabilitation.
- Residual alveolar bone height of 4 mm or less, indicating the need for lateral maxillary sinus augmentation.
- Patients suitable for lateral sinus lift surgery based on clinical and radiographic evaluation.
- Ability to provide written informed consent.
Who cannot join
- Systemic conditions that could affect bone healing (e.g., uncontrolled diabetes, metabolic bone diseases).
- History of radiotherapy or chemotherapy to the head and neck region.
- Active sinus pathology or chronic sinusitis.
- Heavy smoking (more than 10 cigarettes per day).
- Pregnancy or lactation.
- Use of medications known to affect bone metabolism.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Tokat Gaziosmanpaşa University Faculty of Dentistry
Tokat Province, Tokat Province, 60230
About this study
Official title: Radiographic, Histological and Immunohistochemical Evaluation of Allograft, Xenograft, and Combined Grafting in Maxillary Sinus Floor Augmentation: A Prospective Randomized Clinical Study
This prospective randomized clinical study evaluates and compares three different grafting approaches (allograft, xenograft, and combined grafting) used in lateral maxillary sinus augmentation prior to dental implant placement.
Patients with posterior maxillary bone deficiency (residual bone height ≤4 mm) undergoing sinus lift surgery were randomly assigned to one of three grafting groups. Cone-beam computed tomography (CBCT) was used to assess bone height before surgery, immediately after grafting, and at 6 months. During implant placement at 6 months, bone biopsy samples were collected from the grafted sites for histological and immunohistochemical evaluation.
The study aims to assess vertical bone gain, graft height stability, and biological bone healing using osteocalcin, osteopontin, and RUNX2 markers. The results are intended to provide clinically relevant information regarding the volumetric and biological behavior of different graft materials used in maxillary sinus augmentation.
- Being tested
- Lateral Maxillary Sinus Augmentation with Allograft, Lateral Maxillary Sinus Augmentation with Xenograft, Lateral Maxillary Sinus Augmentation with Combined Graft, Dental Implant Placement Without Sinus Augmentation
- Keywords
- Maxillary sinus augmentation, Bone grafts, Dental implants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lateral Maxillary Sinus Augmentation with AllograftProcedure or surgery
Lateral sinus floor elevation was performed using allograft material prior to dental implant placement.
Lateral Maxillary Sinus Augmentation with XenograftProcedure or surgery
Lateral sinus floor elevation was performed using xenograft material prior to dental implant placement.
Lateral Maxillary Sinus Augmentation with Combined GraftProcedure or surgery
Lateral sinus floor elevation was performed using a combination of allograft and xenograft materials prior to dental implant placement.
Dental Implant Placement Without Sinus AugmentationProcedure or surgery
Dental implant placement was performed without sinus augmentation. Bone biopsy samples were obtained from the implant site during implant placement for histological and immunohistochemical evaluation.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Experimental | Patients received dental implant placement without sinus augmentation. Bone biopsy samples were obtained during implant placement for histological and immunohistochemical evaluation. Receives: Procedure: Dental Implant Placement Without Sinus Augmentation |
| Allograft Group | Experimental | Patients underwent lateral maxillary sinus augmentation using allograft material prior to dental implant placement. Bone biopsies were obtained at implant placement for histological and immunohistochemical analyses. Receives: Procedure: Lateral Maxillary Sinus Augmentation with Allograft |
| Xenograft Group | Experimental | Patients underwent lateral maxillary sinus augmentation using xenograft material prior to dental implant placement. Bone biopsies were obtained at implant placement for histological and immunohistochemical analyses. Receives: Procedure: Lateral Maxillary Sinus Augmentation with Xenograft |
| Combined Graft Group | Experimental | Patients underwent lateral maxillary sinus augmentation using a combination of allograft and xenograft materials prior to dental implant placement. Bone biopsies were obtained at implant placement for histological and immunohistochemical analyses. Receives: Procedure: Lateral Maxillary Sinus Augmentation with Combined Graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vertical Bone Height Gain
Vertical bone height gain following lateral maxillary sinus augmentation, measured using cone-beam computed tomography (CBCT).
Measured: 6 months
Secondary outcomes (3)
Graft Height Loss
Change in grafted bone height between early postoperative and 6-month CBCT measurements.
Measured: 6 months
Histological New Bone Formation
Qualitative and semi-quantitative histological evaluation of new bone formation in bone biopsy samples obtained during implant placement.
Measured: 6 months
Immunohistochemical Expression of Osteogenic Markers
Immunohistochemical expression of osteocalcin, osteopontin, and RUNX2 in bone biopsy samples obtained from grafted sites.
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 posted12 Feb 2026
- Study start30 Jun 2022
- Primary completion24 Apr 2024
- Study completion24 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posterior Maxillary AtrophyStudies of the same condition, open and under way.
- 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
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tokat Gaziosmanpasa University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sefa Colak, Tokat Gaziosmanpasa University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07407361
- Sponsor's protocol ID
- 22-KAEK-118
- Acronym
- SINUS-GRAFT
- Status last verified
- Feb 2026
- First submitted
- 5 Feb 2026
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiographic, Histological and Immunohistochemical Evaluation of Allograft, Xenograft, and Combined Grafting in Maxillary Sinus Floor Augmentation: A Prospective Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT07407361
- Acronym / sponsor ID
- SINUS-GRAFT / 22-KAEK-118
- Keywords
- Maxillary sinus augmentation, Bone grafts, Dental implants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Tokat Gaziosmanpasa UniversityUniversity, hospital or other
- Study start
- 30 Jun 2022 (actual)
- Primary completion
- 24 Apr 2024 (actual)
- Study completion
- 24 Apr 2024 (actual)
- First posted
- 12 Feb 2026 (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.
This prospective randomized clinical study evaluates and compares three different grafting approaches (allograft, xenograft, and combined grafting) used in lateral maxillary sinus augmentation prior to dental implant placement.
Patients with posterior maxillary bone deficiency (residual bone height ≤4 mm) undergoing sinus lift surgery were randomly assigned to one of three grafting groups. Cone-beam computed tomography (CBCT) was used to assess bone height before surgery, immediately after grafting, and at 6 months. During implant placement at 6 months, bone biopsy samples were collected from the grafted sites for histological and immunohistochemical evaluation.
The study aims to assess vertical bone gain, graft height stability, and biological bone healing using osteocalcin, osteopontin, and RUNX2 markers. The results are intended to provide clinically relevant information regarding the volumetric and biological behavior of different graft materials used in maxillary sinus augmentation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control Group | Experimental | Procedure: Dental Implant Placement Without Sinus AugmentationPatients received dental implant placement without sinus augmentation. Bone biopsy samples were obtained during implant placement for histological and immunohistochemical evaluation. |
| Allograft Group | Experimental | Procedure: Lateral Maxillary Sinus Augmentation with AllograftPatients underwent lateral maxillary sinus augmentation using allograft material prior to dental implant placement. Bone biopsies were obtained at implant placement for histological and immunohistochemical analyses. |
| Xenograft Group | Experimental | Procedure: Lateral Maxillary Sinus Augmentation with XenograftPatients underwent lateral maxillary sinus augmentation using xenograft material prior to dental implant placement. Bone biopsies were obtained at implant placement for histological and immunohistochemical analyses. |
| Combined Graft Group | Experimental | Procedure: Lateral Maxillary Sinus Augmentation with Combined GraftPatients underwent lateral maxillary sinus augmentation using a combination of allograft and xenograft materials prior to dental implant placement. Bone biopsies were obtained at implant placement for histological and immunohistochemical analyses. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged 18 to 75 years.
- Patients presenting with posterior maxillary edentulism requiring dental implant rehabilitation.
- Residual alveolar bone height of 4 mm or less, indicating the need for lateral maxillary sinus augmentation.
- Patients suitable for lateral sinus lift surgery based on clinical and radiographic evaluation.
- Ability to provide written informed consent.
Key exclusion criteria (6 listed)
- Systemic conditions that could affect bone healing (e.g., uncontrolled diabetes, metabolic bone diseases).
- History of radiotherapy or chemotherapy to the head and neck region.
- Active sinus pathology or chronic sinusitis.
- Heavy smoking (more than 10 cigarettes per day).
- Pregnancy or lactation.
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 |
|---|---|---|
| Lateral Maxillary Sinus Augmentation with AllograftLateral sinus floor elevation was performed using allograft material prior to dental implant placement. | Procedure or surgery | Allograft Group |
| Lateral Maxillary Sinus Augmentation with XenograftLateral sinus floor elevation was performed using xenograft material prior to dental implant placement. | Procedure or surgery | Xenograft Group |
| Lateral Maxillary Sinus Augmentation with Combined GraftLateral sinus floor elevation was performed using a combination of allograft and xenograft materials prior to dental implant placement. | Procedure or surgery | Combined Graft Group |
| Dental Implant Placement Without Sinus AugmentationDental implant placement was performed without sinus augmentation. Bone biopsy samples were obtained from the implant site during implant placement for histological and immunohistochemical evaluation. | Procedure or surgery | Control Group |
Primary outcome
Vertical Bone Height Gain
Time frame: 6 months
Vertical bone height gain following lateral maxillary sinus augmentation, measured using cone-beam computed tomography (CBCT).
3 secondary outcomes
Graft Height Loss
Time frame: 6 months
Histological New Bone Formation
Time frame: 6 months
Immunohistochemical Expression of Osteogenic Markers
Time frame: 6 months
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 12 Feb 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared.
Related trials for Posterior Maxillary Atrophy
Recruiting
Two-Stage Transcrestal Sinus Lift With Osseodensification: Allograft vs Autogenous-Xenograft
Severely Atrophic Posterior Maxilla
Recruiting
Alveolar Ridge Preservation (ARP) in the Posterior Maxilla After the Extraction of Maxillary Molars
Alveolar Bone Loss
RecruitingPhase 2/3
Assessment of a New Enhanced Xenograft in Open Maxillary Sinus Augmentation
Maxillary Sinus Floor Augmentation, Maxillary Sinus Elevation
Recruiting
Graftless TSFE Via Self-tapping Implants
Edentulous Posterior Maxilla, Maxillary Sinus Pneumatization
RecruitingObservational study
Digital Planning and Clinical Assessment of the Treated Atrophic Posterior Maxilla With a Sinus Lift Procedure: a Cross-sectional Study.
Alveolar Bone Atrophy, Alveolar Bone Grafting
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lateral Maxillary Sinus Augmentation with Allograft, Lateral Maxillary Sinus Augmentation with Xenograft and Lateral Maxillary Sinus Augmentation with Combined Graft in people with Posterior Maxillary Atrophy and Maxillary Sinus Augmentation, run by Tokat Gaziosmanpasa University at 1 site in Turkey (Türkiye).
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: finished, as of the sponsor's last update on 12 Feb 2026. 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 Turkey (Türkiye). 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?
Vertical Bone Height Gain (time frame: 6 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 12 Feb 2026.