Bilateral Sinus PneumatizationNCT04778709
Bone Graft Particle Size on Bone Vitality and Volume
A study testing Puros allograft in people with Bilateral Sinus Pneumatization and Posterior Maxillary Ridge Atrophy Due to Extraction, run by NYU College of Dentistry at 1 site in United States.
Trial summary
To determine the effects of small and large bone graft particles vs large particles alone on percent vital bone, percent residual graft material, measured histologically from bone biopsies of the grafted site taken at the time of dental implant placement from subjects undergoing sinus augmentation for the placement of… Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Bilateral Sinus Pneumatization, Posterior Maxillary Ridge Atrophy Due to Extraction
- What is being tested?
- Puros allograft
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Nov 2020to 1 Feb 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Good physical health
- Capable of maintaining good oral hygiene
- Missing posterior maxillary teeth on both sides and less than 5 mm of residual jaw bone requiring maxillary sinus augmentation prior to dental implant placement
- Capable and willing to give informed consent
Who cannot join
- The presence of underlying medical conditions that may pose an undue risk for sinus surgery
- Patients with untreated oral infections
- Pregnant and lactating females
- Individuals who have the habit of smoking and/or tobacco chewing
- Patients not willing to participate in the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Periodontology and Implant Dentistry
New York, New York, 10010
About this study
Official title: A Randomized, Split Mouth Study of the Effects of Bone Graft Particle Size on Bone Vitality and Bone Volume Outcomes in Subjects Undergoing Sinus Augmentation for the Placement of Dental Implants
To determine the effects of small and large bone graft particles vs large particles alone on percent vital bone, percent residual graft material, measured histologically from bone biopsies of the grafted site taken at the time of dental implant placement from subjects undergoing sinus augmentation for the placement of dental implants. Dental radiographs taken post operatively will be used to estimate bone graft volume differences between conditions.
Read the detailed description
The proposed study is a Randomized, single-masked, split-mouth, single center study.
About 20 subjects will be screened in order to randomize 10 study subjects. 10 patients who needing bilateral sinus augmentation procedure using the lateral window technique will be randomized using computer generated randomized technique.
At the day of the surgical procedure each tooth sites will be randomized 1:1 into one of the following bone grafts to either the right or left side of the mouth.:
- Bone graft A: A mixture of 25% small-particle cortical allograft, 25% large-particle cortical allograft, 25% small-particle cancellous allograft, and 25% large-particle cancellous allograft is used for one sinus (N=10)
- Bone graft B: 100% large particle cancellous allograft for the contralateral sinus (N=10) Immediately after the sinus augmentation surgery a CBCT will be acquired and will be compared to a second CBCT prior to implant placement in order to compare the volumetric changes in the sinus.
At the visit of implant placement, a bone core will be collected from both sinuses for histomorphometric evaluation to evaluate the residual graft particles, the new vital bone formation and the amount of soft tissue components.
- Being tested
- Puros allograft
- Keywords
- Sinus floor augmentation, Bone graft, Allograft, Dental implants, Maxillary sinus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Puros allograftDevice
Bilateral sinus augmentation procedure using the lateral window technique. Graft material combination A or B will be randomly assigned to right and left sinus.
Each subject will receive the following bone allograft material:
Four to six grams of commercially available human donor bone allograft (Puros Allograft Bone Particles, Zimmer Biomet, Palm Beach Gardens, FL USA) consisting of Graft A cortical and cancellous bone chips of both 250-1000 microns and 1000-2000 microns size, or Graft B for contralateral sinus: cancellous 1000-2000 microns size alone.
| Study group | Role | What they receive |
|---|---|---|
| Bone Graft A | Experimental | Bone Graft A: Mixture of 25% small-particle cortical, 25% large particle cortical, 25% small particle cancellous, 25% large particle cancellous allograft Receives: Device: Puros allograft |
| Bone Graft B | Active comparator | Bone Graft B: 100% large particle cancellous allograft Receives: Device: Puros allograft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Bone
Assessment of the quality of bone that is generated in the grafted sinuses by measuring the: percent vital bone formation, percent of inflammatory tissue if any
Measured: After surgery, 8 months, 1 year
Quality of Bone
Assessment of the quality of bone that is generated in the grafted sinuses by measuring the: percent of residual bone graft material
Measured: After surgery, 8 months, 1 year
Quality of Bone
Assessment of the quality of bone that is generated in the grafted sinuses by measuring the: percent of inflammatory tissue if any
Measured: After surgery, 8 months, 1 year
Secondary outcomes (1)
Bone Volume Stability
Assessment of bone volume stability through CBCT analysis comparing it from the time of placement, 8 months post-grafting and 1 year post-implantation
Measured: After surgery, 8 months, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2021
- Study start13 Nov 2020
- Primary completion1 Feb 2022
- Study completion1 Feb 2022
Why it stopped: Original PI who is no longer at the institution, the sponsor of this research study, Zimmer Biomet, along with the current PI have decided to close enrollment to the study and to early terminate the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Bilateral Sinus PneumatizationStudies 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
- Each subject will receive bilateral sinus augmentation. Right and left sinuses will be randomly assigned to Bone Graft A and Bone Graft B.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU College of Dentistry
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katerina Georgantza, DDS, NYU College of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04778709
- Sponsor's protocol ID
- 19-00996
- Status last verified
- Nov 2023
- First submitted
- 30 Jan 2021
- Last updated
- 1 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Split Mouth Study of the Effects of Bone Graft Particle Size on Bone Vitality and Bone Volume Outcomes in Subjects Undergoing Sinus Augmentation for the Placement of Dental Implants
- ClinicalTrials.gov ID
- NCT04778709
- Acronym / sponsor ID
- 19-00996
- Keywords
- Sinus floor augmentation, Bone graft, Allograft, Dental implants, Maxillary sinus
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Original PI who is no longer at the institution, the sponsor of this research study, Zimmer Biomet, along with the current PI have decided to close enrollment to the study and to early terminate the study.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- NYU College of DentistryUniversity, hospital or other
- Study start
- 13 Nov 2020 (actual)
- Primary completion
- 1 Feb 2022 (actual)
- Study completion
- 1 Feb 2022 (actual)
- First posted
- 3 Mar 2021 (actual)
- Results
- Posted 1 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine the effects of small and large bone graft particles vs large particles alone on percent vital bone, percent residual graft material, measured histologically from bone biopsies of the grafted site taken at the time of dental implant placement from subjects undergoing sinus augmentation for the placement of dental implants. Dental radiographs taken post operatively will be used to estimate bone graft volume differences between conditions.
Detailed description
The proposed study is a Randomized, single-masked, split-mouth, single center study.
About 20 subjects will be screened in order to randomize 10 study subjects. 10 patients who needing bilateral sinus augmentation procedure using the lateral window technique will be randomized using computer generated randomized technique.
At the day of the surgical procedure each tooth sites will be randomized 1:1 into one of the following bone grafts to either the right or left side of the mouth.:
- Bone graft A: A mixture of 25% small-particle cortical allograft, 25% large-particle cortical allograft, 25% small-particle cancellous allograft, and 25% large-particle cancellous allograft is used for one sinus (N=10)
- Bone graft B: 100% large particle cancellous allograft for the contralateral sinus (N=10) Immediately after the sinus augmentation surgery a CBCT will be acquired and will be compared to a second CBCT prior to implant placement in order to compare the volumetric changes in the sinus.
At the visit of implant placement, a bone core will be collected from both sinuses for histomorphometric evaluation to evaluate the residual graft particles, the new vital bone formation and the amount of soft tissue components.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Each subject will receive bilateral sinus augmentation. Right and left sinuses will be randomly assigned to Bone Graft A and Bone Graft B.
| Arm | Type | Receives |
|---|---|---|
| Bone Graft A | Experimental | Device: Puros allograftBone Graft A: Mixture of 25% small-particle cortical, 25% large particle cortical, 25% small particle cancellous, 25% large particle cancellous allograft |
| Bone Graft B | Active comparator | Device: Puros allograftBone Graft B: 100% large particle cancellous allograft |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Good physical health
- Capable of maintaining good oral hygiene
- Missing posterior maxillary teeth on both sides and less than 5 mm of residual jaw bone requiring maxillary sinus augmentation prior to dental implant placement
- Capable and willing to give informed consent
Key exclusion criteria (5 listed)
- The presence of underlying medical conditions that may pose an undue risk for sinus surgery
- Patients with untreated oral infections
- Pregnant and lactating females
- Individuals who have the habit of smoking and/or tobacco chewing
- Patients not willing to participate in the study
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 |
|---|---|---|
| Puros allograftBilateral sinus augmentation procedure using the lateral window technique. Graft material combination A or B will be randomly assigned to right and left sinus. Each subject will receive the following bone allograft material: Four to six grams of commercially available human donor bone allograft (Puros Allograft Bone Particles, Zimmer Biomet, Palm Beach Gardens, FL USA) consisting of Graft A cortical and cancellous bone chips of both 250-1000 microns and 1000-2000 microns size, or Graft B for contralateral sinus: cancellous 1000-2000 microns size alone. | Device | Bone Graft A, Bone Graft B |
Primary outcome
Quality of Bone
Time frame: After surgery, 8 months, 1 year
Assessment of the quality of bone that is generated in the grafted sinuses by measuring the: percent vital bone formation, percent of inflammatory tissue if any
Quality of Bone
Time frame: After surgery, 8 months, 1 year
Assessment of the quality of bone that is generated in the grafted sinuses by measuring the: percent of residual bone graft material
Quality of Bone
Time frame: After surgery, 8 months, 1 year
Assessment of the quality of bone that is generated in the grafted sinuses by measuring the: percent of inflammatory tissue if any
1 secondary outcome
Bone Volume Stability
Time frame: After surgery, 8 months, 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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 Puros allograft in people with Bilateral Sinus Pneumatization and Posterior Maxillary Ridge Atrophy Due to Extraction, run by NYU College of Dentistry 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 5 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: stopped early, as of the sponsor's last update on 1 Dec 2023. 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?
Yes. Results are posted in the registry (first posted 1 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Quality of Bone (time frame: After surgery, 8 months, 1 year). The study lists 3 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 1 Dec 2023.