Maxillary Sinus Floor AugmentationNCT06247098
Evaluation of Sinus Augmentation Bone Healing Using Autograft and Xenograft Compared to Xenograft Alone
A study testing Sinus Lift augmentation and Cone-beam computed tomography systems (CBCT) in people with Maxillary Sinus Floor Augmentation and Dental Implant, run by Tufts University at 1 site in United States.
Trial summary
To evaluate bone healing at 4 months after lateral sinus augmentation with a 4:1 ratio of autologous bone and xenograft or xenograft alone. A radiographic volumetric, histomorphometric, and histologic analysis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Maxillary Sinus Floor Augmentation, Dental Implant, Bone Substitute
- What is being tested?
- Sinus Lift augmentation and Cone-beam computed tomography systems (CBCT)
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2024to May 2028
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients of Tufts School of Dental Medicine (TUSDM)
- Two stage sinus augmentations with <5mm (Zinner, Small 2004) residual bone height in need of augmentation for implant placement
- Full maxillary edentulism or Kennedy class I or III
- 18 to 100 year old
Who cannot join
- Adults unable to consent (cognitively impaired adults)
- Those who self-report as pregnant or breastfeeding
- Wards of the state
- Non-Viable neonates
- Neonates of uncertain viability
- < 18 years of age
Show all 16Show fewer
- Refusal to participate
- Prior medical condition causing complications in bone metabolism
- Osteoporosis
- History of/or current chemotherapy
- History of/or current head and neck radiation
- Current heavy smoking > 10 cigarettes/day
- Self-reported pregnancy or lactation
- Previous history of sinus elevation procedure
- Existing sinus pathology or pathology discovered at time of sinus augmentation or implant placement
- Absence of autogenous donor site
Trial locations and contacts
1 site in 1 country.
United States1 site
Tufts University School of Dental Medicine
Boston, Massachusetts, 02111
About this study
Official title: Sinus Augmentation Healing With Autogenous and Xenograft Mix Compared to Xenograft Alone
To evaluate bone healing at 4 months after lateral sinus augmentation with a 4:1 ratio of autologous bone and xenograft or xenograft alone. A radiographic volumetric, histomorphometric, and histologic analysis.
- Conditions
- Maxillary Sinus Floor Augmentation, Dental Implant, Bone Substitute, Autogenous Bone Graft
- Being tested
- Sinus Lift augmentation, Cone-beam computed tomography systems (CBCT)
- Keywords
- Histology, Volume measurements, Radiographic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sinus Lift augmentationProcedure or surgery
Randomised Sinus Lift augmentation either with Xenograft - Autogenous ratio 1:4 (test) or Xenograft alone (Control)
Cone-beam computed tomography systems (CBCT)Device
An research only use of CBCT at visit 2 to review healing status.
| Study group | Role | What they receive |
|---|---|---|
| Xenograft - Autogenous 1:4 | Experimental | Sinus grafted with a ratio of Xenograft - Autogenous 1:4 Receives: Procedure: Sinus Lift augmentation; Device: Cone-beam computed tomography systems (CBCT) |
| Xenograft alone | Active comparator | Sinus grafted with Xenograft only Receives: Procedure: Sinus Lift augmentation; Device: Cone-beam computed tomography systems (CBCT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Histological analysis
Mineralized and non-mineralized tissue Remnant particles of biomaterial Inflammatory infiltrate
Measured: 4 months from surgery
Secondary outcomes (2)
Volumetric bone analysis 4 months post sinus augmentation
Sinus volume calculation via CBCT analysis
Measured: 4 months from surgery
Radiographic bone height gain at 4 months
Residual alveolar crest Final alveolar crest height at 4 months Initial height of graft immediately post graft placement Vertical bone material resorption
Measured: 4 months post sinus augmentation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2024
- Study start1 Sep 2024
- Primary completionMay 2027 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lorenzo Mordini, DDS, MS, Principal investigator, Tufts Univeristy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06247098
- Sponsor's protocol ID
- STUDY00004629
- Status last verified
- Jan 2026
- First submitted
- 30 Jan 2024
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Al-Moraissi E, Alhajj WA, Al-Qadhi G, Christidis N. Bone Graft Osseous Changes After Maxillary Sinus Floor Augmentation: A Systematic Review. J Oral Implantol. 2022 Oct 1;48(5):464-471. doi: 10.1563/aaid-joi-D-21-00310.
PubMed 35881815Al-Moraissi EA, Alkhutari AS, Abotaleb B, Altairi NH, Del Fabbro M. Do osteoconductive bone substitutes result in similar bone regeneration for maxillary sinus augmentation when compared to osteogenic and osteoinductive bone grafts? A systematic review and frequentist network meta-analysis. Int J Oral Maxillofac Surg. 2020 Jan;49(1):107-120. doi: 10.1016/j.ijom.2019.05.004. Epub 2019 Jun 21.
PubMed 31230768Barone A, Crespi R, Aldini NN, Fini M, Giardino R, Covani U. Maxillary sinus augmentation: histologic and histomorphometric analysis. Int J Oral Maxillofac Implants. 2005 Jul-Aug;20(4):519-25.
PubMed 16161735
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sinus Augmentation Healing With Autogenous and Xenograft Mix Compared to Xenograft Alone
- ClinicalTrials.gov ID
- NCT06247098
- Acronym / sponsor ID
- STUDY00004629
- Conditions
- Maxillary Sinus Floor Augmentation, Dental Implant, Bone Substitute, Autogenous Bone Graft
- Keywords
- Histology, Volume measurements, Radiographic
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Tufts UniversityUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 7 Feb 2024 (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.
To evaluate bone healing at 4 months after lateral sinus augmentation with a 4:1 ratio of autologous bone and xenograft or xenograft alone. A radiographic volumetric, histomorphometric, and histologic analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Xenograft - Autogenous 1:4 | Experimental | Procedure: Sinus Lift augmentation, Device: Cone-beam computed tomography systems (CBCT)Sinus grafted with a ratio of Xenograft - Autogenous 1:4 |
| Xenograft alone | Active comparator | Procedure: Sinus Lift augmentation, Device: Cone-beam computed tomography systems (CBCT)Sinus grafted with Xenograft only |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients of Tufts School of Dental Medicine (TUSDM)
- Two stage sinus augmentations with <5mm (Zinner, Small 2004) residual bone height in need of augmentation for implant placement
- Full maxillary edentulism or Kennedy class I or III
- 18 to 100 year old
Key exclusion criteria (16 listed)
- Adults unable to consent (cognitively impaired adults)
- Those who self-report as pregnant or breastfeeding
- Wards of the state
- Non-Viable neonates
- Neonates of uncertain viability
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 |
|---|---|---|
| Sinus Lift augmentationRandomised Sinus Lift augmentation either with Xenograft - Autogenous ratio 1:4 (test) or Xenograft alone (Control) | Procedure or surgery | Xenograft - Autogenous 1:4, Xenograft alone |
| Cone-beam computed tomography systems (CBCT)An research only use of CBCT at visit 2 to review healing status. | Device | Xenograft - Autogenous 1:4, Xenograft alone |
Primary outcome
Histological analysis
Time frame: 4 months from surgery
Mineralized and non-mineralized tissue Remnant particles of biomaterial Inflammatory infiltrate
2 secondary outcomes
Volumetric bone analysis 4 months post sinus augmentation
Time frame: 4 months from surgery
Radiographic bone height gain at 4 months
Time frame: 4 months post sinus augmentation
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 23 Jan 2026.
- Background: PubMed 35881815Al-Moraissi E, Alhajj WA, Al-Qadhi G, Christidis N. Bone Graft Osseous Changes After Maxillary Sinus Floor Augmentation: A Systematic Review. J Oral Implantol. 2022 Oct 1;48(5):464-471. doi: 10.1563/aaid-joi-D-21-00310.
- Background: PubMed 31230768Al-Moraissi EA, Alkhutari AS, Abotaleb B, Altairi NH, Del Fabbro M. Do osteoconductive bone substitutes result in similar bone regeneration for maxillary sinus augmentation when compared to osteogenic and osteoinductive bone grafts? A systematic review and frequentist network meta-analysis. Int J Oral Maxillofac Surg. 2020 Jan;49(1):107-120. doi: 10.1016/j.ijom.2019.05.004. Epub 2019 Jun 21.
- Background: PubMed 16161735Barone A, Crespi R, Aldini NN, Fini M, Giardino R, Covani U. Maxillary sinus augmentation: histologic and histomorphometric analysis. Int J Oral Maxillofac Implants. 2005 Jul-Aug;20(4):519-25.
- Individual participant dataSharing planned: No
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. This study is not recruiting at the moment.
Lorenzo Mordini, DDS, MS principal investigator
Tufts Univeristy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sinus Lift augmentation and Cone-beam computed tomography systems (CBCT) in people with Maxillary Sinus Floor Augmentation and Dental Implant, run by Tufts University at 1 site in United States.
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 16 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: under way, not looking for participants, as of the sponsor's last update on 23 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 United States. 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?
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?
Histological analysis (time frame: 4 months from surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06247098, which also lists 3 linked publications.
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 23 Jan 2026.