Mouth, EdentulousNCT00318487
Bilateral Sinus Floor Augmentation in Conjunction With Immediate Implant Loading - Study on 3i Dental Implants
A study testing Bilateral sinus augmentation with immediately loaded dental implants in people with Mouth, Edentulous, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
Fifteen (15) patients completely edentulous in the maxilla will be treated with 8 dental implants. The total treatment will be done in 2 stages to allow, within the same group, a study of two different approaches. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mouth, Edentulous
- What is being tested?
- Bilateral sinus augmentation with immediately loaded dental implants
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Sep 2007to 31 Dec 2012
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers with a full removable denture in the maxilla.
- Subjects must have enough bone to install 4 dental implants in region 14 to 24 and are in need of a sinus lifting procedure in the posterior mandible (region 18-15 + 25-28).
Who cannot join
- Patients with compromised healing capacities such as cancer patients and diabetes patients.
- Smokers are excluded when smoking > 12 cigarettes per day.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bilateral Sinus Floor Augmentation in Conjunction With Immediate Implant Loading - A Clinical and Histomorphometric Follow-Up Study on 3i Dental Implants
Fifteen (15) patients completely edentulous in the maxilla will be treated with 8 dental implants. The total treatment will be done in 2 stages to allow, within the same group, a study of two different approaches. Miniscrews that can be functionally loaded will be provided by 3i with the design and surface textures as wanted by the study sponsor.
Read the detailed description
The department of oral surgery in Ghent has a lot of patients for bilateral sinus lift procedures. The group of patients should have enough bone for installation of 4 dental implants in the area 14-24. In this region 4 implants will be installed and immediate loading with a provisional acrylic (metal reinforced) bridge will be provided. The survival and success of the implants immediate functional loading will be studied (interest point 1). Two different implant surfaces are used in the study to be compared (interest point 2) in relation to peri-implant parameters, radiographical healing, and success criteria at the same time bilateral sinus lifting is performed. One sinus is filled with a mixture of iliac crest bone and Bio-Oss (Geistlich Germany), and the second sinus is filled with calvarial skull bone and Bio-oss. The latter bone combination is appreciated clinically by the surgeons since it leads to a subjectively better implant stability. This, however, remains to be investigated. This study can compare both harvesting techniques and evaluate clinical treatment outcome (interest point 3). Normally, there is a certain waiting time after sinus lifting before dental implants are installed. Recently, however, some literature abstracts indicate that immediate placement of the implants in the sinus lifted bone can be successful. However, this is not done with immediate functional loading. We propose to install in total 6 miniscrews, 2 in each sinus lift area. Four will be loaded immediately and connected rigidly to the other 4 normal sized implants. Actually the immediate loaded bridge will be supported, in total, by 4 normal and 4 miniscrew implants. Four months after loading, the 4 loaded miniscrews are removed with a trephine drill in order to examine soft-tissue healing, bone-implant contact, and bone healing by means of histomorphometry. Since the implants are in cortical bone + sinus lifted bone, it will be possible to examine the given implant surface under immediate loading in both bone conditions (interest point 4). Immediately after removing the miniscrews, they are replaced by the normal sized implants. One side will be randomly assigned for immediate non-functional loading, the other side will be assigned to a non-loaded condition. With this latter design we can mimic the partial sinus lift condition as it is often done 4 months after sinus lifting - the classical procedure. At the time of exposing the implants of the 2-stage procedure, the miniscrews are removed. This gives us an idea of bone healing of an implant installed 4 months after sinus lifting and kept additionally unloaded for 4 months. This gives us histology of immediately loaded implants in healed sinus lifted bone (interest point 5).
- Conditions
- Mouth, Edentulous
- Being tested
- Bilateral sinus augmentation with immediately loaded dental implants
- Keywords
- Dental implants
- Medical subject headings
- Mouth, Edentulous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilateral sinus augmentation with immediately loaded dental implantsProcedure or surgery
Bilateral sinus augmentation with immediately loaded dental implants will be used.
| Study group | Role | What they receive |
|---|---|---|
| Bilateral sinus augmentation | Experimental | Not described Receives: Procedure: Bilateral sinus augmentation with immediately loaded dental implants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of 3i dental implants installed simultaneously with a sinus lift procedure and immediately loaded
Measured: 4 months
Comparison of sinus lift with autogenous iliac crest bone + Bio-Oss and sinus lift with an autogenous calvarial skull bone + Bio-Oss
Measured: 4 months
Installation of implants Prevail and Certain in sinus lift area and naturally healed (non-lifted) bone
Measured: 4 months
Histological comparison between immediately loaded implants in sinus lifted bone versus normal bone
Measured: 4 months
Histological comparison at various time intervals
Measured: 4 months
Histologic findings: integration of the graft, amount of new bone formation, survival and success of the implant, and osseointegration of implant
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2006 (estimated)
- Study start1 Sep 2007
- Primary completion31 Dec 2012
- Study completion31 Dec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mouth, EdentulousStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hugo De Bruyn, MD, PhD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00318487
- Sponsor's protocol ID
- 2006/126
- Status last verified
- Dec 2022
- First submitted
- 11 Apr 2006
- Last updated
- 21 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bilateral Sinus Floor Augmentation in Conjunction With Immediate Implant Loading - A Clinical and Histomorphometric Follow-Up Study on 3i Dental Implants
- ClinicalTrials.gov ID
- NCT00318487
- Acronym / sponsor ID
- 2006/126
- Conditions
- Mouth, Edentulous
- Keywords
- Dental implants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 1 Sep 2007 (actual)
- Primary completion
- 31 Dec 2012 (actual)
- Study completion
- 31 Dec 2012 (actual)
- First posted
- 26 Apr 2006 (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.
Fifteen (15) patients completely edentulous in the maxilla will be treated with 8 dental implants. The total treatment will be done in 2 stages to allow, within the same group, a study of two different approaches. Miniscrews that can be functionally loaded will be provided by 3i with the design and surface textures as wanted by the study sponsor.
Detailed description
The department of oral surgery in Ghent has a lot of patients for bilateral sinus lift procedures. The group of patients should have enough bone for installation of 4 dental implants in the area 14-24. In this region 4 implants will be installed and immediate loading with a provisional acrylic (metal reinforced) bridge will be provided. The survival and success of the implants immediate functional loading will be studied (interest point 1). Two different implant surfaces are used in the study to be compared (interest point 2) in relation to peri-implant parameters, radiographical healing, and success criteria at the same time bilateral sinus lifting is performed. One sinus is filled with a mixture of iliac crest bone and Bio-Oss (Geistlich Germany), and the second sinus is filled with calvarial skull bone and Bio-oss. The latter bone combination is appreciated clinically by the surgeons since it leads to a subjectively better implant stability. This, however, remains to be investigated. This study can compare both harvesting techniques and evaluate clinical treatment outcome (interest point 3). Normally, there is a certain waiting time after sinus lifting before dental implants are installed. Recently, however, some literature abstracts indicate that immediate placement of the implants in the sinus lifted bone can be successful. However, this is not done with immediate functional loading. We propose to install in total 6 miniscrews, 2 in each sinus lift area. Four will be loaded immediately and connected rigidly to the other 4 normal sized implants. Actually the immediate loaded bridge will be supported, in total, by 4 normal and 4 miniscrew implants. Four months after loading, the 4 loaded miniscrews are removed with a trephine drill in order to examine soft-tissue healing, bone-implant contact, and bone healing by means of histomorphometry. Since the implants are in cortical bone + sinus lifted bone, it will be possible to examine the given implant surface under immediate loading in both bone conditions (interest point 4). Immediately after removing the miniscrews, they are replaced by the normal sized implants. One side will be randomly assigned for immediate non-functional loading, the other side will be assigned to a non-loaded condition. With this latter design we can mimic the partial sinus lift condition as it is often done 4 months after sinus lifting - the classical procedure. At the time of exposing the implants of the 2-stage procedure, the miniscrews are removed. This gives us an idea of bone healing of an implant installed 4 months after sinus lifting and kept additionally unloaded for 4 months. This gives us histology of immediately loaded implants in healed sinus lifted bone (interest point 5).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bilateral sinus augmentation | Experimental | Procedure: Bilateral sinus augmentation with immediately loaded dental implants |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy volunteers with a full removable denture in the maxilla.
- Subjects must have enough bone to install 4 dental implants in region 14 to 24 and are in need of a sinus lifting procedure in the posterior mandible (region 18-15 + 25-28).
Key exclusion criteria (2 listed)
- Patients with compromised healing capacities such as cancer patients and diabetes patients.
- Smokers are excluded when smoking > 12 cigarettes per day.
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 |
|---|---|---|
| Bilateral sinus augmentation with immediately loaded dental implantsBilateral sinus augmentation with immediately loaded dental implants will be used. | Procedure or surgery | Bilateral sinus augmentation |
Primary outcome
Comparison of 3i dental implants installed simultaneously with a sinus lift procedure and immediately loaded
Time frame: 4 months
Comparison of sinus lift with autogenous iliac crest bone + Bio-Oss and sinus lift with an autogenous calvarial skull bone + Bio-Oss
Time frame: 4 months
Installation of implants Prevail and Certain in sinus lift area and naturally healed (non-lifted) bone
Time frame: 4 months
Histological comparison between immediately loaded implants in sinus lifted bone versus normal bone
Time frame: 4 months
Histological comparison at various time intervals
Time frame: 4 months
Histologic findings: integration of the graft, amount of new bone formation, survival and success of the implant, and osseointegration of implant
Time frame: 4 months
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 21 Dec 2022.
- Website University Hospital GhentLink provided by the sponsor.
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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.
Hugo De Bruyn, MD, PhD principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bilateral sinus augmentation with immediately loaded dental implants in people with Mouth, Edentulous, run by University Hospital, Ghent at 1 site in Belgium.
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 2 inclusion and 2 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 21 Dec 2022. 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 Belgium. 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?
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?
Comparison of 3i dental implants installed simultaneously with a sinus lift procedure and immediately loaded (time frame: 4 months). The study lists 6 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 21 Dec 2022.