EdentulismPhase 4NCT00868777
The Influence of Dimensional Anatomic Variables on the Outcomes of Maxillary Sinus Grafting Procedures
A Phase 4 study testing Sinus grafting using allogenic bone in people with Edentulism and Alveolar Bone Atrophy, run by University of Michigan at 1 site in United States.
Trial summary
The hypothesis of this study is that there is a significant difference in bone maturation after sinus grafting determined by the distance from the buccal to the palatal wall of this cavity. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Edentulism, Alveolar Bone Atrophy, Sinus Pneumatization
- What is being tested?
- Sinus grafting using allogenic bone
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Mar 2009
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults patients (Older than 18 years), up to 85 years-old.
- Physical status according to the American Society of Anesthesiologists (ASA) I or II
- Patient in need of a sinus grafting using the lateral approach to allow the proper placement of dental implants. The remaining bone height must be 3 mm or less.
- No uncontrolled systemic disease or condition known to alter bone metabolism
- Adequate oral hygiene (O'Leary plaque score ≤20%)
Who cannot join
- Long term (>2 weeks) use of antibiotics in the past 3 months
- Patients smoking more than half-pack a day
- Patients taking medications known to modify bone metabolism (such as bisphosphonates, corticosteroids, etc…)
- Pregnant or attempting to get pregnant
- Patients that don't meet the indications for sinus grafting (Existing sinus conditions, sepsis, history of cancer and/or radiation to the oral cavity, use of biphosphonates, pregnancy), or have postoperative complications related to those conditions.
Trial locations and contacts
1 site in 1 country.
United States1 site
Graduate Periodontics Clinic. School of Dentistry. University of Michigan
Ann Arbor, Michigan, 48109
About this study
The hypothesis of this study is that there is a significant difference in bone maturation after sinus grafting determined by the distance from the buccal to the palatal wall of this cavity.
Read the detailed description
Inadequate alveolar bone height as a consequence of tooth loss is a common limitation for properly placing endosseous dental implants in the posterior maxilla. Grafting of the maxillary sinus has been regarded as one of the most reliable surgical alternatives to correct this problem. Several sinus grafting techniques, using different materials, have been reported showing high survival rates. However, there are many factors that may alter the outcomes of this procedure.
The maturation and consolidation of the grafted area relies on the proper formation of a functional graft-vital bone complex. This maturation process requires an adequate migration of osteogenic cells from native bone, that could be limited in situations where the dimensions of the maxillary sinus are excessive. Hence, the purpose of this research project is to determine the influence of the distance from the lateral to the medial wall of the maxillary sinus on the outcomes of a sinus augmentation procedures performed using the lateral approach using clinical, radiographic and histomorphometric analysis.
- Conditions
- Edentulism, Alveolar Bone Atrophy, Sinus Pneumatization
- Being tested
- Sinus grafting using allogenic bone
- Keywords
- Implant site development, Bone grafting, Dental implants
- Medical subject headings
- Alveolar Bone Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sinus grafting using allogenic boneProcedure or surgery
Also called Mineross - Human allograft
Surgical bone grafting procedure oriented to provide enough bone volume in atrophic posterior maxillary segments, when placement of endosteal implants is planned in order to restore missing teeth.
| Study group | Role | What they receive |
|---|---|---|
| Sinus grafting using allogenic bone | Experimental | Not described Receives: Procedure: Sinus grafting using allogenic bone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Histomorphometric proportion of vital bone
Measured: Six months after sinus bone grafting, after harvesting a bone core biopsy at the time of implant placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2009 (estimated)
- Study startJan 2008
- Primary completionFeb 2009
- Study completionMar 2009
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 EdentulismStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- BioHorizons, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00868777
- Sponsor's protocol ID
- HUM00017520
- Status last verified
- Mar 2009
- First submitted
- 24 Mar 2009
- Last updated
- 25 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Galindo-Moreno P, Avila G, Fernandez-Barbero JE, Mesa F, O'Valle-Ravassa F, Wang HL. Clinical and histologic comparison of two different composite grafts for sinus augmentation: a pilot clinical trial. Clin Oral Implants Res. 2008 Aug;19(8):755-9. doi: 10.1111/j.1600-0501.2008.01536.x.
PubMed 18573123Galindo-Moreno P, Avila G, Fernandez-Barbero JE, Aguilar M, Sanchez-Fernandez E, Cutando A, Wang HL. Evaluation of sinus floor elevation using a composite bone graft mixture. Clin Oral Implants Res. 2007 Jun;18(3):376-82. doi: 10.1111/j.1600-0501.2007.01337.x. Epub 2007 Mar 12.
PubMed 17355356Gosau M, Rink D, Driemel O, Draenert FG. Maxillary sinus anatomy: a cadaveric study with clinical implications. Anat Rec (Hoboken). 2009 Mar;292(3):352-4. doi: 10.1002/ar.20859.
PubMed 19248167
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Dimensional Anatomic Variables on the Outcomes of Maxillary Sinus Grafting Procedures
- ClinicalTrials.gov ID
- NCT00868777
- Acronym / sponsor ID
- HUM00017520
- Conditions
- Edentulism, Alveolar Bone Atrophy, Sinus Pneumatization
- Keywords
- Implant site development, Bone grafting, Dental implants
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- BioHorizons, Inc.
- Study start
- Jan 2008
- Primary completion
- Feb 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 25 Mar 2009 (estimated)
- 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.
The hypothesis of this study is that there is a significant difference in bone maturation after sinus grafting determined by the distance from the buccal to the palatal wall of this cavity.
Detailed description
Inadequate alveolar bone height as a consequence of tooth loss is a common limitation for properly placing endosseous dental implants in the posterior maxilla. Grafting of the maxillary sinus has been regarded as one of the most reliable surgical alternatives to correct this problem. Several sinus grafting techniques, using different materials, have been reported showing high survival rates. However, there are many factors that may alter the outcomes of this procedure.
The maturation and consolidation of the grafted area relies on the proper formation of a functional graft-vital bone complex. This maturation process requires an adequate migration of osteogenic cells from native bone, that could be limited in situations where the dimensions of the maxillary sinus are excessive. Hence, the purpose of this research project is to determine the influence of the distance from the lateral to the medial wall of the maxillary sinus on the outcomes of a sinus augmentation procedures performed using the lateral approach using clinical, radiographic and histomorphometric analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sinus grafting using allogenic bone | Experimental | Procedure: Sinus grafting using allogenic bone |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults patients (Older than 18 years), up to 85 years-old.
- Physical status according to the American Society of Anesthesiologists (ASA) I or II
- Patient in need of a sinus grafting using the lateral approach to allow the proper placement of dental implants. The remaining bone height must be 3 mm or less.
- No uncontrolled systemic disease or condition known to alter bone metabolism
- Adequate oral hygiene (O'Leary plaque score ≤20%)
Key exclusion criteria (5 listed)
- Long term (>2 weeks) use of antibiotics in the past 3 months
- Patients smoking more than half-pack a day
- Patients taking medications known to modify bone metabolism (such as bisphosphonates, corticosteroids, etc…)
- Pregnant or attempting to get pregnant
- Patients that don't meet the indications for sinus grafting (Existing sinus conditions, sepsis, history of cancer and/or radiation to the oral cavity, use of biphosphonates, pregnancy), or have postoperative complications related to those conditions.
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 grafting using allogenic boneAlso: Mineross - Human allograftSurgical bone grafting procedure oriented to provide enough bone volume in atrophic posterior maxillary segments, when placement of endosteal implants is planned in order to restore missing teeth. | Procedure or surgery | Sinus grafting using allogenic bone |
Primary outcome
Histomorphometric proportion of vital bone
Time frame: Six months after sinus bone grafting, after harvesting a bone core biopsy at the time of implant placement
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2009.
- Background: PubMed 18573123Galindo-Moreno P, Avila G, Fernandez-Barbero JE, Mesa F, O'Valle-Ravassa F, Wang HL. Clinical and histologic comparison of two different composite grafts for sinus augmentation: a pilot clinical trial. Clin Oral Implants Res. 2008 Aug;19(8):755-9. doi: 10.1111/j.1600-0501.2008.01536.x.
- Background: PubMed 17355356Galindo-Moreno P, Avila G, Fernandez-Barbero JE, Aguilar M, Sanchez-Fernandez E, Cutando A, Wang HL. Evaluation of sinus floor elevation using a composite bone graft mixture. Clin Oral Implants Res. 2007 Jun;18(3):376-82. doi: 10.1111/j.1600-0501.2007.01337.x. Epub 2007 Mar 12.
- Background: PubMed 19248167Gosau M, Rink D, Driemel O, Draenert FG. Maxillary sinus anatomy: a cadaveric study with clinical implications. Anat Rec (Hoboken). 2009 Mar;292(3):352-4. doi: 10.1002/ar.20859.
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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.
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 Phase 4 study testing Sinus grafting using allogenic bone in people with Edentulism and Alveolar Bone Atrophy, run by University of Michigan 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 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: finished, as of the sponsor's last update on 25 Sep 2009. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Histomorphometric proportion of vital bone (time frame: Six months after sinus bone grafting, after harvesting a bone core biopsy at the time of implant placement). 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 NCT00868777, 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 25 Sep 2009.