Inadequate Bone Height in Maxillary Posterior AreaNCT01911819
A Comparison of Bone Formation With Three Different Bone Graft Materials Following Sinus Graft
A study testing Sinus augmentation, Equimatrix and OSSIF-i sem in people with Inadequate Bone Height in Maxillary Posterior Area, run by Loma Linda University at 1 site in United States.
Trial summary
The purpose of this study is to compare new bone formation following bone graft in sinus using three different commercially available bone graft materials. The study hypothesis is that there is no difference in new bone formation among three bone graft materials under microscope. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Inadequate Bone Height in Maxillary Posterior Area
- What is being tested?
- Sinus augmentation, Equimatrix and OSSIF-i sem
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2013to Jun 2016
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Over 18 years old who are able to read and sign written consent form.
- Patient who has good oral hygiene (Full-mouth plaque score <25%).
- Subject would be available for study monitoring.
- Patients with missing teeth in the maxillary posterior region who will require sinus augmentation f or implant placement. The patients may be partially or completely edentulous.
- Delayed implant placement approximately 8 months following sinus grafting.
Who cannot join
- A medical history that will complicate the outcome of the study such as:
- alcohol, drug dependency,
- signs or symptoms of maxillary sinus disease,
- current smoker,
- history of head and neck radiation treatment,
- poor health or any other medical, physical or psychological reason that might affect the surgical procedure or the subsequent prosthodontic treatment and/or required follow-up examinations.
Trial locations and contacts
1 site in 1 country.
United States1 site
Loma Linda University School of Dentistry
Loma Linda, California, 92350
About this study
Official title: A Histomorphometric Analysis of Bone Formation With Three Different Bone Graft Materials Following Sinus Augmentation
The purpose of this study is to compare new bone formation following bone graft in sinus using three different commercially available bone graft materials. The study hypothesis is that there is no difference in new bone formation among three bone graft materials under microscope.
Read the detailed description
The purpose of this investigation is to compare new bone formation through histomorphometric analysis following maxillary sinus augmentation using three different bone graft materials. Null Hypothesis is that there is no histomorphometric difference in new bone formation in maxillary sinuses augmented using three different materials; anorganic bovine bone graft (Bio-Oss), anorganic equine bone graft (Equimatrix) and mineralized bone allograft (OSSIF-i sem). Patients who require sinus augmentation prior to implant placement will be selected to participate in this study. All patients will be randomly placed into three groups according to bone graft materials that will be used. Group A (Control group,n=10): Maxillary sinus augmentation using anorganic bovine bone graft (Bio-Oss), Group B (Test group,n=10):Maxillary sinus augmentation using anorganic equine bone graft (Equimatrix), and Group C (Test group,n=10):Maxillary sinus augmentation using mineralized bone allograft (OSSIF-i sem). All the patients will be treated with the same surgical technique consisting of sinus floor augmentation via a lateral approach.After a full-thickness flap reflection to expose the lateral wall of the sinus each antrostomy will be outlined with a carbide round bur and sinus membranes will be carefully elevated. If a perforation to the sinus membrane occurs, and if the perforation is < 5 mm in diameter and is able to be repaired, the surgeon will continue the procedure. Any perforation > 5 mm will be excluded from this study. Bone graft materials will be placed into the each sinus compartment for the three groups. After 8 months of healing, biopsy specimen will be collected from the previous antrostomy sites. Histomorphometric measurements of the percentage of vital bone of the area of bone. The percentage of non-bone material (allograft or xenograft) and the percentage of connective tissue will be also analyzed. Then the primary hypothesis will be analyzed statistically.
- Being tested
- Sinus augmentation, Equimatrix, OSSIF-i sem, Bio-oss
- Keywords
- Histomorphometric Analysis, New bone Formation, Sinus Augmentation, Bone Graft Materials
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sinus augmentationProcedure or surgery
EquimatrixDrug
Equimatrix cancellous particle size 0.2-1mm approximately 2g (4cc)
OSSIF-i semDrug
OSSIF-i sem Mineralized Cancellous Bone Allograft SP 0.25-1.0mm approximately 2cc x 2
Bio-ossDrug
Bio-oss small granules cancellous 0.25-1mm, approximately 2g (4cc)
| Study group | Role | What they receive |
|---|---|---|
| Sinus augmentation using Bio-oss | Experimental | Sinus augmentation using Bio-oss Receives: Procedure: Sinus augmentation; Drug: Bio-oss |
| Sinus augmentation using Equimatrix | Experimental | Sinus augmentation using Equimatrix Receives: Procedure: Sinus augmentation; Drug: Equimatrix |
| Sinus augmentation using OSSIF-i sem | Experimental | Sinus augmentation using OSSIF-i sem Receives: Procedure: Sinus augmentation; Drug: OSSIF-i sem |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Percentage of Vital Bone in a Total Amount of a Bone Specimen
Bone biopsy was taken in a mean of 9.1 months after sinus graft procedure from previous lateral window of maxillary sinus. The bone cores were analyzed though histomorphometric analysis.
Measured: 24months
Secondary outcomes (1)
The Percentage of Non-vital Bone/Residual Bone Graft Material in a Bone.
Bone biopsy was taken in a mean of 9.1 months after sinus graft procedure from previous lateral window of maxillary sinus. The bone cores were analyzed though histomorphometric analysis.
Measured: 24months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2013 (estimated)
- Study startDec 2013
- Primary completionJun 2016
- Study completionJun 2016
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 Inadequate Bone Height in Maxillary Posterior AreaStudies of the same condition, open and under way.
- More trials run by Loma Linda 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Collaborators
- American Regent, Inc.
- Responsible party
- Principal investigator, Joseph Kan, DDS, Loma Linda University
- Investigators
- Joseph Kan, DDS, MS, Principal investigator, Loma Linda University School of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01911819
- Sponsor's protocol ID
- 5130213
- Status last verified
- Nov 2017
- First submitted
- 18 Jul 2013
- Last updated
- 13 Dec 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Histomorphometric Analysis of Bone Formation With Three Different Bone Graft Materials Following Sinus Augmentation
- ClinicalTrials.gov ID
- NCT01911819
- Acronym / sponsor ID
- 5130213
- Keywords
- Histomorphometric Analysis, New bone Formation, Sinus Augmentation, Bone Graft Materials
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Collaborators
- American Regent, Inc.
- Study start
- Dec 2013
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 30 Jul 2013 (estimated)
- Results
- Posted 13 Dec 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare new bone formation following bone graft in sinus using three different commercially available bone graft materials. The study hypothesis is that there is no difference in new bone formation among three bone graft materials under microscope.
Detailed description
The purpose of this investigation is to compare new bone formation through histomorphometric analysis following maxillary sinus augmentation using three different bone graft materials. Null Hypothesis is that there is no histomorphometric difference in new bone formation in maxillary sinuses augmented using three different materials; anorganic bovine bone graft (Bio-Oss), anorganic equine bone graft (Equimatrix) and mineralized bone allograft (OSSIF-i sem). Patients who require sinus augmentation prior to implant placement will be selected to participate in this study. All patients will be randomly placed into three groups according to bone graft materials that will be used. Group A (Control group,n=10): Maxillary sinus augmentation using anorganic bovine bone graft (Bio-Oss), Group B (Test group,n=10):Maxillary sinus augmentation using anorganic equine bone graft (Equimatrix), and Group C (Test group,n=10):Maxillary sinus augmentation using mineralized bone allograft (OSSIF-i sem). All the patients will be treated with the same surgical technique consisting of sinus floor augmentation via a lateral approach.After a full-thickness flap reflection to expose the lateral wall of the sinus each antrostomy will be outlined with a carbide round bur and sinus membranes will be carefully elevated. If a perforation to the sinus membrane occurs, and if the perforation is < 5 mm in diameter and is able to be repaired, the surgeon will continue the procedure. Any perforation > 5 mm will be excluded from this study. Bone graft materials will be placed into the each sinus compartment for the three groups. After 8 months of healing, biopsy specimen will be collected from the previous antrostomy sites. Histomorphometric measurements of the percentage of vital bone of the area of bone. The percentage of non-bone material (allograft or xenograft) and the percentage of connective tissue will be also analyzed. Then the primary hypothesis will be analyzed statistically.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sinus augmentation using Bio-oss | Experimental | Procedure: Sinus augmentation, Drug: Bio-ossSinus augmentation using Bio-oss |
| Sinus augmentation using Equimatrix | Experimental | Procedure: Sinus augmentation, Drug: EquimatrixSinus augmentation using Equimatrix |
| Sinus augmentation using OSSIF-i sem | Experimental | Procedure: Sinus augmentation, Drug: OSSIF-i semSinus augmentation using OSSIF-i sem |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Over 18 years old who are able to read and sign written consent form.
- Patient who has good oral hygiene (Full-mouth plaque score <25%).
- Subject would be available for study monitoring.
- Patients with missing teeth in the maxillary posterior region who will require sinus augmentation f or implant placement. The patients may be partially or completely edentulous.
- Delayed implant placement approximately 8 months following sinus grafting.
Key exclusion criteria (6 listed)
- alcohol, drug dependency,
- signs or symptoms of maxillary sinus disease,
- current smoker,
- history of head and neck radiation treatment,
- poor health or any other medical, physical or psychological reason that might affect the surgical procedure or the subsequent prosthodontic treatment and/or required follow-up examinations.
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 augmentation | Procedure or surgery | Sinus augmentation using Bio-oss, Sinus augmentation using Equimatrix, Sinus augmentation using OSSIF-i sem |
| EquimatrixEquimatrix cancellous particle size 0.2-1mm approximately 2g (4cc) | Drug | Sinus augmentation using Equimatrix |
| OSSIF-i semOSSIF-i sem Mineralized Cancellous Bone Allograft SP 0.25-1.0mm approximately 2cc x 2 | Drug | Sinus augmentation using OSSIF-i sem |
| Bio-ossBio-oss small granules cancellous 0.25-1mm, approximately 2g (4cc) | Drug | Sinus augmentation using Bio-oss |
Primary outcome
The Percentage of Vital Bone in a Total Amount of a Bone Specimen
Time frame: 24months
Bone biopsy was taken in a mean of 9.1 months after sinus graft procedure from previous lateral window of maxillary sinus. The bone cores were analyzed though histomorphometric analysis.
1 secondary outcome
The Percentage of Non-vital Bone/Residual Bone Graft Material in a Bone.
Time frame: 24months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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.
Joseph Kan, DDS, MS principal investigator
Loma Linda University School of Dentistry
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 augmentation, Equimatrix and OSSIF-i sem in people with Inadequate Bone Height in Maxillary Posterior Area, run by Loma Linda 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 5 inclusion and 6 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 13 Dec 2017. 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 13 Dec 2017). 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?
The Percentage of Vital Bone in a Total Amount of a Bone Specimen (time frame: 24months). 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 13 Dec 2017; AzTrials last refreshed its copy on 1 Nov 2026.