Maxillary Sinus Floor AugmentationPhase 1NCT07090694
PRF vs. Graftless Sinus Lift With Implant Placement
A Phase 1 study testing Graftless Transcrestal Sinus Floor Elevation with Immediate Implant Placement and Platelet-Rich Fibrin (PRF)-Assisted Transcrestal Sinus Floor Elevation with Immediate Implant Placement in people with Maxillary Sinus Floor Augmentation and Alveolar Bone Loss, run by Dar Al Uloom University at 1 site in Saudi Arabia.
Trial summary
The goal of this clinical trial is to evaluate the effectiveness of sinus floor elevation using platelet-rich fibrin (PRF) compared to a graftless approach in adult patients with atrophic posterior maxilla (residual bone height 5-7 mm) requiring dental implant rehabilitation. Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Maxillary Sinus Floor Augmentation, Alveolar Bone Loss, Atrophy
- What is being tested?
- Graftless Transcrestal Sinus Floor Elevation with Immediate Implant Placement and Platelet-Rich Fibrin (PRF)-Assisted Transcrestal Sinus Floor Elevation with Immediate Implant Placement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Feb 2025to Aug 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 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 25 to 65 years
- Patients with one or more missing posterior maxillary teeth
- Residual alveolar bone height between 5 mm and 7 mm, confirmed by CBCT
- Good oral hygiene and motivation for implant therapy
- Adequate inter-arch space for prosthetic rehabilitation
- Absence of maxillary sinus pathology on radiographic assessment
- Patients willing to undergo single-stage implant placement with sinus lift
- Signed informed consent
Who cannot join
- Systemic diseases or medical conditions affecting bone metabolism or wound healing (e.g., uncontrolled diabetes, osteoporosis, immunocompromised status)
- History of radiation therapy in the head and neck region
- Use of medications influencing bone turnover (e.g., bisphosphonates, corticosteroids)
- Active periodontal disease or poor oral hygiene
- Smoking or tobacco use
- Parafunctional habits such as bruxism or clenching
Show all 10Show fewer
- Pregnancy or breastfeeding
- Known bleeding disorders or abnormal coagulation profiles
- Presence of maxillary sinus infection or pathology
- Inability to attend follow-up visits or comply with study protocol
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Saudi Arabia1 site
College of Dentistry, Dar AlUloom University
Riyadh, 11512
About this study
Official title: Transcrestal Sinus Elevation With or Without PRF for Atrophic Maxilla: A Randomized Clinical Evaluation
The goal of this clinical trial is to evaluate the effectiveness of sinus floor elevation using platelet-rich fibrin (PRF) compared to a graftless approach in adult patients with atrophic posterior maxilla (residual bone height 5-7 mm) requiring dental implant rehabilitation. The main questions it aims to answer are:
Does PRF enhance bone height gain more effectively than graftless sinus elevation? Does PRF improve implant stability and reduce marginal bone loss compared to the graftless approach? Researchers will compare the outcomes of PRF-grafted implants versus non-grafted implants to see if PRF improves radiographic and clinical results in single-stage implant placement.
Read more
Participants will:
Undergo internal sinus lift via crestal drilling approach
Be randomly assigned to one of two groups:
Group I: sinus lift without graft material Group II: sinus lift with PRF as the sole grafting material Receive simultaneous dental implant placement during the sinus lift Be monitored through clinical exams and radiographic imaging over 6 months postoperatively
Read the detailed description
This randomized controlled clinical trial investigates the clinical and radiographic outcomes of crestal sinus floor elevation in the atrophic posterior maxilla, comparing two approaches: one using platelet-rich fibrin (PRF) as a sole grafting material and another performed without any grafting material. Both interventions are combined with single-stage dental implant placement. The rationale for this study is based on emerging evidence suggesting that graftless techniques, relying on blood clot stabilization and tenting of the sinus membrane, may be sufficient to induce predictable bone formation, especially when residual alveolar bone height is ≥5 mm.
The study involves adult patients presenting with edentulous posterior maxillary regions and limited vertical bone height due to sinus pneumatization and ridge resorption.
Participants are randomly allocated to either PRF or graftless groups. Both groups undergo transcrestal sinus elevation through sequential osteotomy, followed by immediate implant placement under a standardized surgical and prosthetic protocol.
Primary outcomes include radiographic bone gain and implant stability quotient (ISQ), while secondary outcomes include marginal bone loss and peri-implant clinical parameters. Radiographic evaluation is conducted using CBCT imaging at baseline and 6 months postoperatively. This study aims to provide evidence on whether PRF offers added clinical benefit over natural healing and clot formation in sinus lift procedures performed via the less invasive crestal approach.
- Conditions
- Maxillary Sinus Floor Augmentation, Alveolar Bone Loss, Atrophy, Platelet-rich Fibrin, Dental Implant
- Being tested
- Graftless Transcrestal Sinus Floor Elevation with Immediate Implant Placement, Platelet-Rich Fibrin (PRF)-Assisted Transcrestal Sinus Floor Elevation with Immediate Implant Placement
- Keywords
- Transcrestal Sinus Lift, Crestal Approach Sinus Floor Elevation, Maxillary Sinus Augmentation, Platelet-Rich Fibrin, Single-Stage Implant Placement, Atrophic Posterior Maxilla
- Medical subject headings
- Alveolar Bone Loss, Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Graftless Transcrestal Sinus Floor Elevation with Immediate Implant PlacementProcedure or surgery
This intervention involves a minimally invasive internal (crestal) sinus lift performed without the use of any grafting material. The sinus membrane is elevated using sequential osteotomy drills, and a dental implant is immediately placed into the prepared site. The implant fixture acts as a tent pole, maintaining the lifted membrane and allowing for spontaneous bone regeneration through blood clot formation alone. This graftless method eliminates the need for additional biomaterials and is intended for patients with residual alveolar bone height of 5-7 mm
Platelet-Rich Fibrin (PRF)-Assisted Transcrestal Sinus Floor Elevation with Immediate Implant PlacementBiological
This intervention utilizes autologous platelet-rich fibrin (PRF) as the sole grafting material during transcrestal sinus floor elevation. PRF is prepared from the patient's own venous blood using centrifugation and inserted into the osteotomy site after sinus membrane elevation. A dental implant is placed simultaneously to support the sinus membrane and stabilize the graft. The biologically active PRF matrix provides a scaffold rich in growth factors (e.g., TGF-β, PDGF, VEGF), promoting accelerated healing and enhanced bone formation beneath the elevated sinus floor. This technique is performed in a single-stage procedure, eliminating the need for synthetic or allogeneic grafts.
| Study group | Role | What they receive |
|---|---|---|
| Graftless Sinus Elevation with Simultaneous Implant Placement | Experimental | Participants in this arm undergo crestal sinus floor elevation without the use of any grafting material. The procedure involves a transcrestal (internal) sinus lift through sequential osteotomy followed by immediate placement of dental implants. The elevated sinus membrane is maintained by the implant fixture alone, allowing for natural blood clot formation and spontaneous bone regeneration. Receives: Procedure: Graftless Transcrestal Sinus Floor Elevation with Immediate Implant Placement |
| PRF-Grafted Sinus Elevation with Simultaneous Implant Placement | Active comparator | Participants in this arm undergo crestal sinus floor elevation using platelet-rich fibrin (PRF) as the sole grafting material. PRF is prepared from the patient's own blood via centrifugation and inserted into the osteotomy site. A dental implant is then placed immediately, supporting the sinus membrane and serving as a tent for guided bone regeneration. This technique utilizes PRF's growth factors to promote healing and enhance new bone formation beneath the elevated sinus membrane. Receives: Biological: Platelet-Rich Fibrin (PRF)-Assisted Transcrestal Sinus Floor Elevation with Immediate Implant Placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic Bone Height Gain
Vertical bone gain measured using Cone Beam Computed Tomography (CBCT) from the alveolar crest to the elevated sinus floor. The measurement is taken at baseline (preoperatively) and compared with measurements at 6 months postoperatively to evaluate the success of sinus augmentation.
Measured: Baseline and 6 months postoperatively
Secondary outcomes (2)
Implant Stability Quotient (ISQ)
Measurement of primary and secondary implant stability using an Osstell device. ISQ values are recorded at the time of implant placement and at 6 months postoperatively to assess osseointegration and mechanical stability.
Measured: Immediate postoperative (Day 0) and 6 months postoperatively
Marginal Bone Loss
Radiographic evaluation of crestal bone loss measured at the mesial and distal aspects of the implant using CBCT or standardized periapical radiographs. The difference in marginal bone height from baseline to 6 months will be calculated to assess peri-implant bone preservation.
Measured: Baseline and 6 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2025
- Study start1 Feb 2025
- Primary completionAug 2025 (estimated)
- Study completionAug 2025 (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 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dar Al Uloom University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sally Abd-ElMeniem ElHaddad, Dar Al Uloom University
- Investigators
- SREIC College of Dentistry, Dar AlUloom University, Scientific Committee, Study director, Dar AlUloom University, SA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07090694
- Sponsor's protocol ID
- 038- 003- 2025
- Status last verified
- Jul 2025
- First submitted
- 21 Jul 2025
- Last updated
- 29 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Demographic data (age, sex) Baseline clinical measurements (residual bone height, CBCT parameters) Implant stability quotient (ISQ) values Radiographic bone gain and marginal bone loss measurements Adverse events or complications (if any)
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcrestal Sinus Elevation With or Without PRF for Atrophic Maxilla: A Randomized Clinical Evaluation
- ClinicalTrials.gov ID
- NCT07090694
- Acronym / sponsor ID
- 038- 003- 2025
- Conditions
- Maxillary Sinus Floor Augmentation, Alveolar Bone Loss, Atrophy, Platelet-rich Fibrin, Dental Implant
- Keywords
- Transcrestal Sinus Lift, Crestal Approach Sinus Floor Elevation, Maxillary Sinus Augmentation, Platelet-Rich Fibrin, Single-Stage Implant Placement, Atrophic Posterior Maxilla
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Dar Al Uloom UniversityUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 29 Jul 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.
The goal of this clinical trial is to evaluate the effectiveness of sinus floor elevation using platelet-rich fibrin (PRF) compared to a graftless approach in adult patients with atrophic posterior maxilla (residual bone height 5-7 mm) requiring dental implant rehabilitation. The main questions it aims to answer are:
Does PRF enhance bone height gain more effectively than graftless sinus elevation? Does PRF improve implant stability and reduce marginal bone loss compared to the graftless approach? Researchers will compare the outcomes of PRF-grafted implants versus non-grafted implants to see if PRF improves radiographic and clinical results in single-stage implant placement.
Participants will:
Undergo internal sinus lift via crestal drilling approach
Be randomly assigned to one of two groups:
Group I: sinus lift without graft material Group II: sinus lift with PRF as the sole grafting material Receive simultaneous dental implant placement during the sinus lift Be monitored through clinical exams and radiographic imaging over 6 months postoperatively
Detailed description
This randomized controlled clinical trial investigates the clinical and radiographic outcomes of crestal sinus floor elevation in the atrophic posterior maxilla, comparing two approaches: one using platelet-rich fibrin (PRF) as a sole grafting material and another performed without any grafting material. Both interventions are combined with single-stage dental implant placement. The rationale for this study is based on emerging evidence suggesting that graftless techniques, relying on blood clot stabilization and tenting of the sinus membrane, may be sufficient to induce predictable bone formation, especially when residual alveolar bone height is ≥5 mm.
The study involves adult patients presenting with edentulous posterior maxillary regions and limited vertical bone height due to sinus pneumatization and ridge resorption.
Participants are randomly allocated to either PRF or graftless groups. Both groups undergo transcrestal sinus elevation through sequential osteotomy, followed by immediate implant placement under a standardized surgical and prosthetic protocol.
Primary outcomes include radiographic bone gain and implant stability quotient (ISQ), while secondary outcomes include marginal bone loss and peri-implant clinical parameters. Radiographic evaluation is conducted using CBCT imaging at baseline and 6 months postoperatively. This study aims to provide evidence on whether PRF offers added clinical benefit over natural healing and clot formation in sinus lift procedures performed via the less invasive crestal approach.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Graftless Sinus Elevation with Simultaneous Implant Placement | Experimental | Procedure: Graftless Transcrestal Sinus Floor Elevation with Immediate Implant PlacementParticipants in this arm undergo crestal sinus floor elevation without the use of any grafting material. The procedure involves a transcrestal (internal) sinus lift through sequential osteotomy followed by immediate placement of dental implants. The elevated sinus membrane is maintained by the implant fixture alone, allowing for natural blood clot formation and spontaneous bone regeneration. |
| PRF-Grafted Sinus Elevation with Simultaneous Implant Placement | Active comparator | Biological: Platelet-Rich Fibrin (PRF)-Assisted Transcrestal Sinus Floor Elevation with Immediate Implant PlacementParticipants in this arm undergo crestal sinus floor elevation using platelet-rich fibrin (PRF) as the sole grafting material. PRF is prepared from the patient's own blood via centrifugation and inserted into the osteotomy site. A dental implant is then placed immediately, supporting the sinus membrane and serving as a tent for guided bone regeneration. This technique utilizes PRF's growth factors to promote healing and enhance new bone formation beneath the elevated sinus membrane. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Adults aged 25 to 65 years
- Patients with one or more missing posterior maxillary teeth
- Residual alveolar bone height between 5 mm and 7 mm, confirmed by CBCT
- Good oral hygiene and motivation for implant therapy
- Adequate inter-arch space for prosthetic rehabilitation
Key exclusion criteria (10 listed)
- Systemic diseases or medical conditions affecting bone metabolism or wound healing (e.g., uncontrolled diabetes, osteoporosis, immunocompromised status)
- History of radiation therapy in the head and neck region
- Use of medications influencing bone turnover (e.g., bisphosphonates, corticosteroids)
- Active periodontal disease or poor oral hygiene
- Smoking or tobacco use
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 |
|---|---|---|
| Graftless Transcrestal Sinus Floor Elevation with Immediate Implant PlacementThis intervention involves a minimally invasive internal (crestal) sinus lift performed without the use of any grafting material. The sinus membrane is elevated using sequential osteotomy drills, and a dental implant is immediately placed into the prepared site. The implant fixture acts as a tent pole, maintaining the lifted membrane and allowing for spontaneous bone regeneration through blood clot formation alone. This graftless method eliminates the need for additional biomaterials and is intended for patients with residual alveolar bone height of 5-7 mm | Procedure or surgery | Graftless Sinus Elevation with Simultaneous Implant Placement |
| Platelet-Rich Fibrin (PRF)-Assisted Transcrestal Sinus Floor Elevation with Immediate Implant PlacementThis intervention utilizes autologous platelet-rich fibrin (PRF) as the sole grafting material during transcrestal sinus floor elevation. PRF is prepared from the patient's own venous blood using centrifugation and inserted into the osteotomy site after sinus membrane elevation. A dental implant is placed simultaneously to support the sinus membrane and stabilize the graft. The biologically active PRF matrix provides a scaffold rich in growth factors (e.g., TGF-β, PDGF, VEGF), promoting accelerated healing and enhanced bone formation beneath the elevated sinus floor. This technique is performed in a single-stage procedure, eliminating the need for synthetic or allogeneic grafts. | Biological | PRF-Grafted Sinus Elevation with Simultaneous Implant Placement |
Primary outcome
Radiographic Bone Height Gain
Time frame: Baseline and 6 months postoperatively
Vertical bone gain measured using Cone Beam Computed Tomography (CBCT) from the alveolar crest to the elevated sinus floor. The measurement is taken at baseline (preoperatively) and compared with measurements at 6 months postoperatively to evaluate the success of sinus augmentation.
2 secondary outcomes
Implant Stability Quotient (ISQ)
Time frame: Immediate postoperative (Day 0) and 6 months postoperatively
Marginal Bone Loss
Time frame: Baseline and 6 months postoperatively
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 29 Jul 2025.
- Individual participant dataSharing planned: Yes. Demographic data (age, sex) Baseline clinical measurements (residual bone height, CBCT parameters) Implant stability quotient (ISQ) values Radiographic bone gain and marginal bone loss measurements Adverse events or complications (if any)
Related trials for Maxillary Sinus Floor Augmentation
Recruiting
Two Bovine Xenografts in Lateral Window Sinus Augmentation With or Without Bone Marrow Blood
Alveolar Bone Loss, Sinus Floor Augmentation
Recruiting
The Application of a Biphasic Calcium Sulfate Graft Material in Sinus Floor Elevation
Alveolar Bone Loss, Edentulism Nos
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
Enrolling by invitation
Closed Sinus Augmentation With a Calcium Phosphosilicate Putty
Dental Implant, Maxillary Sinus Floor Augmentation
RecruitingPhase 2/3
Assessment of a New Enhanced Xenograft in Open Maxillary Sinus Augmentation
Maxillary Sinus Floor Augmentation, Maxillary Sinus Elevation
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.
SREIC College of Dentistry, Dar AlUloom University, Scientific Committee study director
Dar AlUloom University, SA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Graftless Transcrestal Sinus Floor Elevation with Immediate Implant Placement and Platelet-Rich Fibrin (PRF)-Assisted Transcrestal Sinus Floor Elevation with Immediate Implant Placement in people with Maxillary Sinus Floor Augmentation and Alveolar Bone Loss, run by Dar Al Uloom University at 1 site in Saudi Arabia.
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 8 inclusion and 10 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: enrolling by invitation, as of the sponsor's last update on 29 Jul 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 Saudi Arabia. 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?
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?
Radiographic Bone Height Gain (time frame: Baseline and 6 months postoperatively). 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 29 Jul 2025.