Bone GraftingMSA-BGCNCT07512011
Outcomes of Different Bone Graft Combinations for Maxillary Sinus Augmentation Procedure
An observational study of Bone Grafting and Sinus Lifting, run by Ohio State University at 1 site in United States.
Trial summary
This study investigates the outcomes of a surgical procedure that is performed to increase bone support at a future implant site on the upper back jaw area. This procedure requires placing bone graft material and/or substitutes into the maxillary sinus. The average healing time for the graft is about 6 months. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bone Grafting, Sinus Lifting
- What is being tested?
- Bone grafting on both sides
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2026to Jun 2028
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients of the Graduate Periodontics Clinic at The Ohio State University College of Dentistry who missing their upper back teeth (both sides) and interested in having implant supported dental restorations
Who may be able to join
- Indication of bilateral sinus augmentation through lateral window technique to prepare maxillary right and left posterior edentulous sites for a single or multiple unit implant supported restorations.
- Systemically healthy with controlled conditions
- Periodontally healthy/controlled dentition
- No known chronic and/or seasonal sinusitis
- No previous ear, nose, throat, and sinus surgeries
- Non-smokers
- Willing to be treated with allograft, xenograft and/or synthetic bone graft materials
Who cannot join
- 1. Indication of sinus augmentation through indirect techniques (≥5 mm initial alveolar ridge height from crest to maxillary sinus floor)
- Implant placement surgery planned somewhere else
- Implant placement planned at the time of sinus augmentation
- Cases requiring major alveolar ridge augmentation concurrent with sinus augmentation
- Cases requiring the use of a partial denture with buccal flange extension during the post-operative period
- History of previously failed implant and/sinus augmentation procedures
Show all 15Show fewer
- History of tumors and/or radiation and/or chemotherapy
- Uncontrolled systemic health problems and ENT/sinus concerns
- Uncontrolled periodontal/dental problems
- Intake of medications affecting wound or bone healing (e.g., corticosteroids, immunosuppressants, etc.)
- Alcohol or drug abuse
- Active smokers (patient should be a non-smoker for at least 1 year prior to sinus augmentation procedure)
- Unable/unwilling to follow post-operative instructions, rejecting to be treated with allograft, xenograft and/or synthetic bone graft materials
- Unable/unwilling to attend scheduled study visits
- Participation in another clinical trial within 3 months prior to planned study entry
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
The Ohio State University College of Dentistry
Columbus, Ohio, 43210
Binnaz Leblebicioglu, DDS, MS, PhD, 614-292-0371, leblebicioglu.1@osu.edu
About this study
Official title: Maxillary Sinus Augmentation Through Lateral Window Technique: Outcomes of Different Bone Graft Combinations (MSA-BGC STUDY)
This study investigates the outcomes of a surgical procedure that is performed to increase bone support at a future implant site on the upper back jaw area. This procedure requires placing bone graft material and/or substitutes into the maxillary sinus. The average healing time for the graft is about 6 months. Then, the site will be ready for dental implant. The study will compare healing outcomes of two types of bone graft mixtures used on the same patient (right and left upper jaw regions). The outcomes will be evaluated through clinical examination but also by studying the quality of the tissue through tissue biopsies obtained from grafted sites.
- Conditions
- Bone Grafting, Sinus Lifting
- Being tested
- Bone grafting on both sides
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone grafting on both sidesDevice
The surgical protocol is part of standard of care and will not be changed due to the study except the choice of the bone graft. Routinely (as the standard protocol), allograft (Straumann Allograft mineralized cortical granules [0.25-1mm]) is mixed with xenograft (bovine bone; Bio-Oss® small particles [0.25-1mm]) bone graft and placed into sinus. In this study, one randomly chosen sinus will receive this mixture (50:50 by volume) as the control. The other sinus on the same patient will receive a 50:50 (by volume) mixture of the same allograft with synthetic carbonate apatite (Cytrans® granules S size [0.3-0.6 mm]).
| Study group | Role | What they receive |
|---|---|---|
| Bone graft patients | Patients who are missing their upper back teeth and interested in having implant supported dental restorations, and who require direct sinus augmentation procedure on both right and left maxillary sinus prior to implant placement. Receives: Device: Bone grafting on both sides |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in ridge dimensions
Dimensions of the alveolar ridge, determined by measurements using an intraoral scanner
Measured: Prior to procedure; 10 days post-procedure; 1 month post-procedure; 6 months post-procedure
Change in Bone Density
Bone density around the dental implant, measured via CBCT
Measured: Prior to the procedure; 4 months post-procedure
Bone quality at 6 months
At implant surgery, 6 months post-grafting, a bone core sample will be taken. This tissue is normally removed during the implant procedure but it typically discarded. Histological analysis will be done on the sample
Measured: About 6 months post-grafting procedure
Patient-Centered Outcomes
Participants will be asked to keep a diary to record pain level and pain medications taken.
Measured: Days 1-10 post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2026
- Study startNov 2026 (estimated)
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone GraftingStudies of the same condition, open and under way.
- More trials run by Ohio State 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Binnaz Leblebicioglu, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07512011
- Sponsor's protocol ID
- STUDY20251371
- Acronym
- MSA-BGC
- Status last verified
- Aug 2026
- First submitted
- 29 Mar 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maxillary Sinus Augmentation Through Lateral Window Technique: Outcomes of Different Bone Graft Combinations (MSA-BGC STUDY)
- ClinicalTrials.gov ID
- NCT07512011
- Acronym / sponsor ID
- MSA-BGC / STUDY20251371
- Conditions
- Bone Grafting, Sinus Lifting
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 6 Apr 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 investigates the outcomes of a surgical procedure that is performed to increase bone support at a future implant site on the upper back jaw area. This procedure requires placing bone graft material and/or substitutes into the maxillary sinus. The average healing time for the graft is about 6 months. Then, the site will be ready for dental implant. The study will compare healing outcomes of two types of bone graft mixtures used on the same patient (right and left upper jaw regions). The outcomes will be evaluated through clinical examination but also by studying the quality of the tissue through tissue biopsies obtained from grafted sites.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bone graft patients | – | Device: Bone grafting on both sidesPatients who are missing their upper back teeth and interested in having implant supported dental restorations, and who require direct sinus augmentation procedure on both right and left maxillary sinus prior to implant placement. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients of the Graduate Periodontics Clinic at The Ohio State University College of Dentistry who missing their upper back teeth (both sides) and interested in having implant supported dental restorations
Key inclusion criteria (7 listed)
- Indication of bilateral sinus augmentation through lateral window technique to prepare maxillary right and left posterior edentulous sites for a single or multiple unit implant supported restorations.
- Systemically healthy with controlled conditions
- Periodontally healthy/controlled dentition
- No known chronic and/or seasonal sinusitis
- No previous ear, nose, throat, and sinus surgeries
Key exclusion criteria (15 listed)
- 1. Indication of sinus augmentation through indirect techniques (≥5 mm initial alveolar ridge height from crest to maxillary sinus floor)
- Implant placement surgery planned somewhere else
- Implant placement planned at the time of sinus augmentation
- Cases requiring major alveolar ridge augmentation concurrent with sinus augmentation
- Cases requiring the use of a partial denture with buccal flange extension during the post-operative period
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 |
|---|---|---|
| Bone grafting on both sidesThe surgical protocol is part of standard of care and will not be changed due to the study except the choice of the bone graft. Routinely (as the standard protocol), allograft (Straumann Allograft mineralized cortical granules [0.25-1mm]) is mixed with xenograft (bovine bone; Bio-Oss® small particles [0.25-1mm]) bone graft and placed into sinus. In this study, one randomly chosen sinus will receive this mixture (50:50 by volume) as the control. The other sinus on the same patient will receive a 50:50 (by volume) mixture of the same allograft with synthetic carbonate apatite (Cytrans® granules S size [0.3-0.6 mm]). | Device | Bone graft patients |
Primary outcome
Change in ridge dimensions
Time frame: Prior to procedure; 10 days post-procedure; 1 month post-procedure; 6 months post-procedure
Dimensions of the alveolar ridge, determined by measurements using an intraoral scanner
Change in Bone Density
Time frame: Prior to the procedure; 4 months post-procedure
Bone density around the dental implant, measured via CBCT
Bone quality at 6 months
Time frame: About 6 months post-grafting procedure
At implant surgery, 6 months post-grafting, a bone core sample will be taken. This tissue is normally removed during the implant procedure but it typically discarded. Histological analysis will be done on the sample
Patient-Centered Outcomes
Time frame: Days 1-10 post-procedure
Participants will be asked to keep a diary to record pain level and pain medications taken.
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 14 Sep 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bone Grafting and Sinus Lifting, run by Ohio State 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 7 inclusion and 15 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: opening soon, as of the sponsor's last update on 14 Sep 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?
Contact Binnaz Leblebicioglu, DDS, MS, PhD (614-292-0371, leblebicioglu.1@osu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in ridge dimensions (time frame: Prior to procedure; 10 days post-procedure; 1 month post-procedure; 6 months post-procedure). The study lists 4 primary outcomes in all. 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 14 Sep 2026.