Posterior Maxilla Edentulous Patients With Insufficient Alveolar Bone HeightNCT01781221
Sinus Floor Elevation Using Separately Two Different Xenografts - A Prospective Randomized Clinical Trial
A study testing Alpha-Bio's GRAFT Natural Bovine Bone and Bio-Oss xenograft in people with Posterior Maxilla Edentulous Patients With Insufficient Alveolar Bone Height, run by University Hospital of Cologne.
Trial summary
The purpose of this study is to compare the regenerative results of using separately two different xenografts after two-step sinus floor elevation. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Posterior Maxilla Edentulous Patients With Insufficient Alveolar Bone Height
- What is being tested?
- Alpha-Bio's GRAFT Natural Bovine Bone and Bio-Oss xenograft
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- Feb 2013to Jan 2018
- Phase
- Interventional
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients who will present with a moderately or severely atrophic posterior maxilla with 1-6 mm residual alveolar bone .
- Men and women over the age of 18 years.
- Patient has signed the Informed Consent.
Who cannot join
- Chronic steroid therapy.
- Uncontrolled diabetes.
- Cardiovascular disease.
- Past irradiation of head and neck.
- Maxillary sinus cysts.
- Active chronic sinusitis.
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- Smoking more than ten cigarettes per day during the 3 months preceding this study .
- Malignant disease in the 5 years preceding this study.
- Uncontrolled bleeding disorders such as: hemophilia, thrombocytopenia, granulocytopenia
- Disease that compromise the immune system
- Psychiatric disorder
- Hypersensitivity to titanium, collagen or bovine bone.
- Women who are pregnant or nursing.
- Patients with non-treated periodontal disease.
- Medical and/or general contraindications for intraoral surgical procedures.
About this study
The purpose of this study is to compare the regenerative results of using separately two different xenografts after two-step sinus floor elevation.
- Being tested
- Alpha-Bio's GRAFT Natural Bovine Bone, Bio-Oss xenograft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alpha-Bio's GRAFT Natural Bovine BoneDevice
Bio-Oss xenograftDevice
| Study group | Role | What they receive |
|---|---|---|
| Alpha-Bio's GRAFT Natural Bovine Bone | Active comparator | two different bone substitutes commonly used in dental procedures. Receives: Device: Alpha-Bio's GRAFT Natural Bovine Bone |
| Bio-Oss xenograft | Active comparator | two different bone substitutes commonly used in dental procedures. Receives: Device: Bio-Oss xenograft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uneventful healing and histological bone formation
Measured: 6 months following sinus floor augmentation
Secondary outcomes (2)
X-ray demonstration of volume - stable results
Measured: 6 months following augmentation procedures.
Equally high implant survival rates and crestal bone loss
Measured: After 1,2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2013 (estimated)
- Study startFeb 2013
- Primary completionJan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posterior Maxilla Edentulous Patients With Insufficient Alveolar Bone HeightStudies 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
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital of Cologne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01781221
- Sponsor's protocol ID
- 12-200
- Status last verified
- Jan 2013
- First submitted
- 10 Jan 2013
- Last updated
- 31 Jan 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sinus Floor Elevation Using Separately Two Different Xenografts - A Prospective Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01781221
- Acronym / sponsor ID
- 12-200
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- University Hospital of CologneUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Jan 2018 (estimated)
- First posted
- 31 Jan 2013 (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 purpose of this study is to compare the regenerative results of using separately two different xenografts after two-step sinus floor elevation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alpha-Bio's GRAFT Natural Bovine Bone | Active comparator | Device: Alpha-Bio's GRAFT Natural Bovine Bonetwo different bone substitutes commonly used in dental procedures. |
| Bio-Oss xenograft | Active comparator | Device: Bio-Oss xenografttwo different bone substitutes commonly used in dental procedures. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who will present with a moderately or severely atrophic posterior maxilla with 1-6 mm residual alveolar bone .
- Men and women over the age of 18 years.
- Patient has signed the Informed Consent.
Key exclusion criteria (15 listed)
- Chronic steroid therapy.
- Uncontrolled diabetes.
- Cardiovascular disease.
- Past irradiation of head and neck.
- Maxillary sinus cysts.
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 |
|---|---|---|
| Alpha-Bio's GRAFT Natural Bovine Bone | Device | Alpha-Bio's GRAFT Natural Bovine Bone |
| Bio-Oss xenograft | Device | Bio-Oss xenograft |
Primary outcome
Uneventful healing and histological bone formation
Time frame: 6 months following sinus floor augmentation
2 secondary outcomes
X-ray demonstration of volume - stable results
Time frame: 6 months following augmentation procedures.
Equally high implant survival rates and crestal bone loss
Time frame: After 1,2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2013.
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.
Questions about this trial
What is this clinical trial studying?
A study testing Alpha-Bio's GRAFT Natural Bovine Bone and Bio-Oss xenograft in people with Posterior Maxilla Edentulous Patients With Insufficient Alveolar Bone Height, run by University Hospital of Cologne.
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 3 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: status not confirmed, as of the sponsor's last update on 31 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Uneventful healing and histological bone formation (time frame: 6 months following sinus floor augmentation). 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 31 Jan 2013.