Maxillary Sinus AugmentationNCT07348198
Histologic and Histomorphometric Evaluation of Lateral Maxillary Sinus Augmentation With or Without Platelet-Rich Fibrin
A study testing Lateral Maxillary Sinus Augmentation With DFDBA and Lateral Maxillary Sinus Augmentation With DFDBA and PRF in people with Maxillary Sinus Augmentation and Posterior Maxillary Atrophy, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
This study evaluates bone healing after lateral maxillary sinus lift surgery performed prior to dental implant placement. This surgical procedure is commonly used when there is insufficient bone height in the upper jaw to support dental implants. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Maxillary Sinus Augmentation, Posterior Maxillary Atrophy
- What is being tested?
- Lateral Maxillary Sinus Augmentation With DFDBA and Lateral Maxillary Sinus Augmentation With DFDBA and PRF
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Apr 2025to 22 Oct 2025
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 to 70 years.
- Patients requiring bilateral lateral maxillary sinus augmentation for dental implant placement.
- Adequate residual alveolar bone height allowing for lateral sinus floor elevation.
- Good general health (ASA I or II).
- Ability to understand the study procedures and provide written informed consent.
Who cannot join
- Presence of systemic diseases affecting bone metabolism (e.g., uncontrolled diabetes, osteoporosis).
- History of head and neck radiotherapy.
- Use of medications known to affect bone healing (e.g., bisphosphonates, corticosteroids).
- Active sinus pathology or chronic sinusitis.
- Heavy smoking (>10 cigarettes per day).
- Pregnancy or lactation.
- Poor oral hygiene or untreated periodontal disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Histologic and Histomorphometric Evaluation of Lateral Maxillary Sinus Augmentation Using Demineralized Freeze-Dried Bone Allograft With or Without Platelet-Rich Fibrin: A Prospective Split-Mouth Clinical Study
This study evaluates bone healing after lateral maxillary sinus lift surgery performed prior to dental implant placement. This surgical procedure is commonly used when there is insufficient bone height in the upper jaw to support dental implants.
Patients who required sinus lift surgery on both sides of the upper jaw were included in the study. In each patient, one side was treated with a demineralized freeze-dried bone allograft (DFDBA) alone, while the opposite side received the same bone graft combined with platelet-rich fibrin (PRF). PRF is a blood-derived material prepared from the patient's own blood and is thought to support tissue healing. The treatment side receiving PRF was determined randomly.
Read more
Six months after the sinus lift surgery, dental implants were placed. At that time, small bone samples were collected from the grafted areas. These samples were examined under a microscope to assess new bone formation and the amount of remaining graft material.
The purpose of this study was to determine whether adding PRF to DFDBA improves bone regeneration compared with DFDBA alone during lateral maxillary sinus augmentation.v
Read the detailed description
This study was designed as a prospective randomized split-mouth clinical investigation to assess bone regeneration following lateral maxillary sinus augmentation using two different grafting approaches.
Patients presenting with bilateral posterior maxillary edentulism and requiring sinus floor elevation prior to dental implant placement were enrolled. Each patient received demineralized freeze-dried bone allograft (DFDBA) alone on one side and DFDBA combined with platelet-rich fibrin (PRF) on the contralateral side, with treatment allocation determined randomly.
All sinus augmentation procedures were performed using a standardized lateral window technique. Platelet-rich fibrin was prepared from autologous venous blood immediately before surgery according to established centrifugation protocols. A fixed healing period of six months was observed prior to implant placement.
During implant surgery, bone core specimens were harvested from the grafted sinus regions using trephine burs. Histologic and histomorphometric analyses were conducted in a blinded manner to quantify tissue composition, including newly formed bone, residual graft material, and connective tissue.
The study aimed to compare the regenerative outcomes of the two grafting strategies and to evaluate the adjunctive role of PRF when combined with an osteoinductive allograft material in lateral maxillary sinus augmentation.
- Being tested
- Lateral Maxillary Sinus Augmentation With DFDBA, Lateral Maxillary Sinus Augmentation With DFDBA and PRF
- Keywords
- sinus augmentation, Split-mouth design, Platelet-rich fibrin, Histomorphometric analysis, Dental implants, demineralized freeze-dried bone allograft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lateral Maxillary Sinus Augmentation With DFDBAProcedure or surgery
Lateral sinus floor elevation using demineralized freeze-dried bone allograft for bone augmentation prior to implant placement.
Lateral Maxillary Sinus Augmentation With DFDBA and PRFProcedure or surgery
Lateral sinus floor elevation using demineralized freeze-dried bone allograft combined with autologous platelet-rich fibrin.
| Study group | Role | What they receive |
|---|---|---|
| Non- PRF(DFDBA Alone) | Experimental | Lateral maxillary sinus augmentation performed using demineralized freeze-dried bone allograft (DFDBA) alone. Receives: Procedure: Lateral Maxillary Sinus Augmentation With DFDBA |
| PRF(DFDBA + PRF) | Experimental | Lateral sinus floor elevation using demineralized freeze-dried bone allograft combined with autologous platelet-rich fibrin. Receives: Procedure: Lateral Maxillary Sinus Augmentation With DFDBA and PRF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Histomorphometric New Bone Formation (%)
The percentage of newly formed bone in biopsy samples obtained from the augmented maxillary sinus, evaluated by histomorphometric analysis.
Measured: 6 months after lateral maxillary sinus augmentation
Secondary outcomes (2)
Residual Graft Material (%)
The percentage of residual graft material remaining in biopsy samples obtained from the augmented maxillary sinus, assessed by histomorphometric analysis.
Measured: 6 months after lateral maxillary sinus augmentation
Connective Tissue (%)
The percentage of connective tissue present in biopsy samples obtained from the augmented maxillary sinus, evaluated using histomorphometric analysis.
Measured: 6 months after lateral maxillary sinus augmentation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start7 Apr 2025
- Primary completion10 Oct 2025
- Study completion22 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maxillary Sinus AugmentationStudies 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
- Crossover
- Model description
- This is a prospective, randomized, split-mouth (within-subject) clinical trial in which each participant receives both interventions on contralateral maxillary sinuses.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erkin Doğan, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07348198
- Sponsor's protocol ID
- Biruni Uni. 2015-KAEK-76-23-07
- Status last verified
- Jan 2026
- First submitted
- 9 Jan 2026
- Last updated
- 16 Jan 2026
- 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 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Histologic and Histomorphometric Evaluation of Lateral Maxillary Sinus Augmentation Using Demineralized Freeze-Dried Bone Allograft With or Without Platelet-Rich Fibrin: A Prospective Split-Mouth Clinical Study
- ClinicalTrials.gov ID
- NCT07348198
- Acronym / sponsor ID
- Biruni Uni. 2015-KAEK-76-23-07
- Keywords
- sinus augmentation, Split-mouth design, Platelet-rich fibrin, Histomorphometric analysis, Dental implants, demineralized freeze-dried bone allograft
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 7 Apr 2025 (actual)
- Primary completion
- 10 Oct 2025 (actual)
- Study completion
- 22 Oct 2025 (actual)
- First posted
- 16 Jan 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 study evaluates bone healing after lateral maxillary sinus lift surgery performed prior to dental implant placement. This surgical procedure is commonly used when there is insufficient bone height in the upper jaw to support dental implants.
Patients who required sinus lift surgery on both sides of the upper jaw were included in the study. In each patient, one side was treated with a demineralized freeze-dried bone allograft (DFDBA) alone, while the opposite side received the same bone graft combined with platelet-rich fibrin (PRF). PRF is a blood-derived material prepared from the patient's own blood and is thought to support tissue healing. The treatment side receiving PRF was determined randomly.
Six months after the sinus lift surgery, dental implants were placed. At that time, small bone samples were collected from the grafted areas. These samples were examined under a microscope to assess new bone formation and the amount of remaining graft material.
The purpose of this study was to determine whether adding PRF to DFDBA improves bone regeneration compared with DFDBA alone during lateral maxillary sinus augmentation.v
Detailed description
This study was designed as a prospective randomized split-mouth clinical investigation to assess bone regeneration following lateral maxillary sinus augmentation using two different grafting approaches.
Patients presenting with bilateral posterior maxillary edentulism and requiring sinus floor elevation prior to dental implant placement were enrolled. Each patient received demineralized freeze-dried bone allograft (DFDBA) alone on one side and DFDBA combined with platelet-rich fibrin (PRF) on the contralateral side, with treatment allocation determined randomly.
All sinus augmentation procedures were performed using a standardized lateral window technique. Platelet-rich fibrin was prepared from autologous venous blood immediately before surgery according to established centrifugation protocols. A fixed healing period of six months was observed prior to implant placement.
During implant surgery, bone core specimens were harvested from the grafted sinus regions using trephine burs. Histologic and histomorphometric analyses were conducted in a blinded manner to quantify tissue composition, including newly formed bone, residual graft material, and connective tissue.
The study aimed to compare the regenerative outcomes of the two grafting strategies and to evaluate the adjunctive role of PRF when combined with an osteoinductive allograft material in lateral maxillary sinus augmentation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This is a prospective, randomized, split-mouth (within-subject) clinical trial in which each participant receives both interventions on contralateral maxillary sinuses.
| Arm | Type | Receives |
|---|---|---|
| Non- PRF(DFDBA Alone) | Experimental | Procedure: Lateral Maxillary Sinus Augmentation With DFDBALateral maxillary sinus augmentation performed using demineralized freeze-dried bone allograft (DFDBA) alone. |
| PRF(DFDBA + PRF) | Experimental | Procedure: Lateral Maxillary Sinus Augmentation With DFDBA and PRFLateral sinus floor elevation using demineralized freeze-dried bone allograft combined with autologous platelet-rich fibrin. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged 18 to 70 years.
- Patients requiring bilateral lateral maxillary sinus augmentation for dental implant placement.
- Adequate residual alveolar bone height allowing for lateral sinus floor elevation.
- Good general health (ASA I or II).
- Ability to understand the study procedures and provide written informed consent.
Key exclusion criteria (7 listed)
- Presence of systemic diseases affecting bone metabolism (e.g., uncontrolled diabetes, osteoporosis).
- History of head and neck radiotherapy.
- Use of medications known to affect bone healing (e.g., bisphosphonates, corticosteroids).
- Active sinus pathology or chronic sinusitis.
- Heavy smoking (>10 cigarettes per day).
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 DFDBALateral sinus floor elevation using demineralized freeze-dried bone allograft for bone augmentation prior to implant placement. | Procedure or surgery | Non- PRF(DFDBA Alone) |
| Lateral Maxillary Sinus Augmentation With DFDBA and PRFLateral sinus floor elevation using demineralized freeze-dried bone allograft combined with autologous platelet-rich fibrin. | Procedure or surgery | PRF(DFDBA + PRF) |
Primary outcome
Histomorphometric New Bone Formation (%)
Time frame: 6 months after lateral maxillary sinus augmentation
The percentage of newly formed bone in biopsy samples obtained from the augmented maxillary sinus, evaluated by histomorphometric analysis.
2 secondary outcomes
Residual Graft Material (%)
Time frame: 6 months after lateral maxillary sinus augmentation
Connective Tissue (%)
Time frame: 6 months after lateral maxillary sinus augmentation
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 16 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for Maxillary Sinus Augmentation
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Enrolling by invitationPhase 1
Smart Scaffolds, Stronger Smiles Smarter Healing: AI-Boosted Multiphasic Scaffold Design for PDL Regeneration
Regeneration of Alveolar Tissue After Maxillary Sinus Floor Augmentation
Not yet recruitingEarly Phase 1
Radiographic Changes in the Maxillary Sinus Following Closed Sinus Augmentation With Leukocyte Platelet Rich Fibrin
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Endoscopic-Assisted Versus Conventional Crestal Sinus Lift
Bone Defects
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 DFDBA and Lateral Maxillary Sinus Augmentation With DFDBA and PRF in people with Maxillary Sinus Augmentation and Posterior Maxillary Atrophy, run by Marmara 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 7 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 16 Jan 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?
Histomorphometric New Bone Formation (%) (time frame: 6 months after lateral maxillary sinus augmentation). 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 16 Jan 2026.