Missing TeethNCT03059914
A Histomorphometric Analysis Following Sinus Augmentation Using Two Different Bone Graft Materials.
A study testing InterOss and Bio-oss in people with Missing Teeth, run by Loma Linda University at 1 site in United States.
Trial summary
The purpose of this investigator-initiated study is to compare new bone formation through histomorphometric analysis following maxillary sinus augmentation using two different bone graft materials. Read more about this study
- Who is it for?
- Ages 18 to 103 yearsHealthy volunteers can take part
- Conditions the study is for
- Missing Teeth
- What is being tested?
- InterOss and Bio-oss
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Aug 2017to 26 Jun 2020
- 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 to 103 years
- 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 an informed consent form.
- Patient who has good oral hygiene (Full-mouth plaque score <25%).
- Subject would be available for study monitoring and follow-up visits.
- Patients with missing teeth in the maxillary posterior region who will require sinus augmentation for implant placement. The patients may be partially or completely edentulous.
- Patient is a candidate for delayed implant placement approximately 8 months following sinus grafting
Who cannot join
- Alcohol, drug dependency.
- Signs or symptoms of chronic maxillary sinus disease.
- Current smoker.
- History of head and neck radiation treatment.
- Poor health, conditions like uncontrolled diabetes, uncontrolled hypertension or other uncontrolled systemic disease.
- Physical or psychological reason that might affect the surgical procedure or the subsequent prosthodontic treatment and/or required follow-up examinations.
- Also, subjects who are nursing or pregnant will be excluded from the study.
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 New Bone Formation Following Sinus Augmentation Using Two Different Bone Graft Materials. A Pilot Study in Humans.
The purpose of this investigator-initiated study is to compare new bone formation through histomorphometric analysis following maxillary sinus augmentation using two different bone graft materials. A total of twenty, sinus augmentation via a lateral approach will be performed for subjects requiring sinus augmentation for implant placement and randomly divided into 2 groups. These subjects will receive one of two different bone graft materials: 1) Anorganic bovine bone matrix- InterOss (Group A), 2) Anorganic bovine bone matrix- Bio-oss (Group B). At the time of implant placement (eight months after the sinus augmentation procedure), two bone biopsies will be collected from augmented site for the histomorphometric analysis. The percentage of vital bone will be measured and analyzed statistically, also the following will be measured: percentage of non-vital bone, percentage of non-bone material , and the percentage of connective tissue.
Read the detailed description
Bovine xenograft has been established as a gold standard in maxillary sinus floor augmentation. This study was initiated to compare two different types of bovine xenografts following maxillary sinus floor augmentation. The comparison will performed using histomorphometric analysis of bone cores removed from the grafted sites. The patients that meet the guidelines for maxillary sinus floor augmentation via lateral window approach are randomly assigned into control and test groups. The surgery is performed by the same surgeon under the same protocols. The subjects in Group A - test group receive InterOss bone graft and subjects in Group B- Control Group receive BioOss bone graft. After eight months of healing at the sites, the patients are subjected to CBCT evaluation in preparation for implant placement. At the time of implant placement the two bone cores are collected from each grafted site using trephine burs. One bone core is collected from the crestal bone that will be site of implant placement and the second bone core is collected from the lateral window area not to interfere with the implant site. These bone cores are stored intact inside the trephine burs, fixed, stored and transported to the lab for histomorphometric analysis. The following parameters are measured and reported after the histomorphometric analysis.
percentage of vital bone percentage of non-vital bone ( graft material) percentage of non-bone material percentage of connective tissue.
- Conditions
- Missing Teeth
- Being tested
- InterOss, Bio-oss
- Medical subject headings
- Anodontia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterOssDevice
Anorganic bovine bone mineral - Xenograft
Bio-ossDevice
Anorganic bovine bone mineral ( Xenograft)
| Study group | Role | What they receive |
|---|---|---|
| InterOss | Experimental | Maxillary sinus augmentation using ABBM Inteross ( Xenograft) Receives: Device: InterOss |
| Bio-oss | Active comparator | Maxillary sinus augmentation using ABBM Bio-oss ( Xenograft) Receives: Device: Bio-oss |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of New Vital Bone.
Vital bone as seen in histology from the collected bone cores.
Measured: 8 months post operative after the initial sinus augmentation surgery.
Secondary outcomes (2)
Cumulative Percentage of Bone Marrow and Fibrous Tissue
Cumulative percentage of Bone marrow and fibrous tissue as seen in histology.
Measured: Eight months post-op sinus augmentation
Space
Space seen the histology specimen not filled with either bone or fibrous tissue in the bone core specimens.
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start10 Aug 2017
- Primary completion26 Jun 2020
- Study completion26 Jun 2020
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 Missing TeethStudies 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
- Participant
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jaime Lozada, Loma Linda University
- Investigators
- Jaime Lozada, Principal investigator, Loma Linda University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03059914
- Sponsor's protocol ID
- 5170069
- Status last verified
- Apr 2024
- First submitted
- 16 Feb 2017
- Last updated
- 1 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- 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 1 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Histomorphometric Analysis of New Bone Formation Following Sinus Augmentation Using Two Different Bone Graft Materials. A Pilot Study in Humans.
- ClinicalTrials.gov ID
- NCT03059914
- Acronym / sponsor ID
- 5170069
- Conditions
- Missing Teeth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- 10 Aug 2017 (actual)
- Primary completion
- 26 Jun 2020 (actual)
- Study completion
- 26 Jun 2020 (actual)
- First posted
- 23 Feb 2017 (actual)
- Results
- Posted 1 May 2024
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 investigator-initiated study is to compare new bone formation through histomorphometric analysis following maxillary sinus augmentation using two different bone graft materials. A total of twenty, sinus augmentation via a lateral approach will be performed for subjects requiring sinus augmentation for implant placement and randomly divided into 2 groups. These subjects will receive one of two different bone graft materials: 1) Anorganic bovine bone matrix- InterOss (Group A), 2) Anorganic bovine bone matrix- Bio-oss (Group B). At the time of implant placement (eight months after the sinus augmentation procedure), two bone biopsies will be collected from augmented site for the histomorphometric analysis. The percentage of vital bone will be measured and analyzed statistically, also the following will be measured: percentage of non-vital bone, percentage of non-bone material , and the percentage of connective tissue.
Detailed description
Bovine xenograft has been established as a gold standard in maxillary sinus floor augmentation. This study was initiated to compare two different types of bovine xenografts following maxillary sinus floor augmentation. The comparison will performed using histomorphometric analysis of bone cores removed from the grafted sites. The patients that meet the guidelines for maxillary sinus floor augmentation via lateral window approach are randomly assigned into control and test groups. The surgery is performed by the same surgeon under the same protocols. The subjects in Group A - test group receive InterOss bone graft and subjects in Group B- Control Group receive BioOss bone graft. After eight months of healing at the sites, the patients are subjected to CBCT evaluation in preparation for implant placement. At the time of implant placement the two bone cores are collected from each grafted site using trephine burs. One bone core is collected from the crestal bone that will be site of implant placement and the second bone core is collected from the lateral window area not to interfere with the implant site. These bone cores are stored intact inside the trephine burs, fixed, stored and transported to the lab for histomorphometric analysis. The following parameters are measured and reported after the histomorphometric analysis.
percentage of vital bone percentage of non-vital bone ( graft material) percentage of non-bone material percentage of connective tissue.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| InterOss | Experimental | Device: InterOssMaxillary sinus augmentation using ABBM Inteross ( Xenograft) |
| Bio-oss | Active comparator | Device: Bio-ossMaxillary sinus augmentation using ABBM Bio-oss ( Xenograft) |
Who may qualify
- Ages
- 18 to 103 years
- 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 an informed consent form.
- Patient who has good oral hygiene (Full-mouth plaque score <25%).
- Subject would be available for study monitoring and follow-up visits.
- Patients with missing teeth in the maxillary posterior region who will require sinus augmentation for implant placement. The patients may be partially or completely edentulous.
- Patient is a candidate for delayed implant placement approximately 8 months following sinus grafting
Key exclusion criteria (7 listed)
- Alcohol, drug dependency.
- Signs or symptoms of chronic maxillary sinus disease.
- Current smoker.
- History of head and neck radiation treatment.
- Poor health, conditions like uncontrolled diabetes, uncontrolled hypertension or other uncontrolled systemic disease.
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 |
|---|---|---|
| InterOssAnorganic bovine bone mineral - Xenograft | Device | InterOss |
| Bio-ossAnorganic bovine bone mineral ( Xenograft) | Device | Bio-oss |
Primary outcome
Percentage of New Vital Bone.
Time frame: 8 months post operative after the initial sinus augmentation surgery.
Vital bone as seen in histology from the collected bone cores.
2 secondary outcomes
Cumulative Percentage of Bone Marrow and Fibrous Tissue
Time frame: Eight months post-op sinus augmentation
Space
Time frame: 8 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Missing Teeth
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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. This study is not recruiting at the moment.
Jaime Lozada principal investigator
Loma Linda University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing InterOss and Bio-oss in people with Missing Teeth, 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 7 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 1 May 2024. 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 May 2024). 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?
Percentage of New Vital Bone. (time frame: 8 months post operative after the initial sinus augmentation surgery.). 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 May 2024.