Patient Who is Requiring Bilateral Sinus Floor Elevation and Necessity of Dental SurgeryEMDOGAIMNCT01870960
Maxillary Sinus Floor Augmentation With Bioss® and Enamel Matrix Derivative: Evaluation of Osteogenic Properties
A study testing 7 patients will be recuting to received EMDOGAIM in left side and 7 patients will be recuting to received EMDOGAIM in right side in people with Patient Who is Requiring Bilateral Sinus Floor Elevation and Necessity of Dental Surgery, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
The main problem of using xenogenic bone in sinus floor elevation is the slow rate of absorption, which gives the percentages of vital bone low (20 to 30% depending on the study) in which the dental implant will be positioned However, osseointegration of the implant can be achieved only in vital bone. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Patient Who is Requiring Bilateral Sinus Floor Elevation and Necessity of Dental Surgery
- What is being tested?
- 7 patients will be recuting to received EMDOGAIM in left side and 7 patients will be recuting to received EMDOGAIM in right side
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteFrance
- Study dates
- 6 Jun 2014to 12 Apr 2017
- 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients > 45 years, postmenopausal women (ie with amenorrhea for more than a year).
- Subject requiring bilateral sinus floor elevation, in order to place two implants in grafted side.
- patients smoking less than 10 cigarettes per day
- patients having read and understood the information note on the study and signed the informed consent form.
- patients affiliated to the social security system.
Who cannot join
- Patient with absolute contra-indication for dental surgery: valvular heart disease at risk of infectious endocarditis, recent myocardal (≤ 12 months), organ transplants, recent placement of a coronary stent (≤ 12 months), transient ischemic attacks recurrent, cardiovascular instability, uncontrolled epilepsy, rheumatic fever.
- Patient with metabolic bone disease (Paget's disease, osteomalacia, osteogenesis imperfecta)
- Patient with an ASA score ≥ 3.
- Patient with absolute contra-indication to dental surgery
- Patient with severe hematologic disease
- Patient with I or type II diabetes
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- Patients with previous or current acute illness or severe chronic cardiovascular, renal, hepatic, gastrointestinal, allergic, endocrine, neuro-psychiatric, considered by the investigator to be incompatible with the conduct of the study.
- Patients treated with retinoids, oral bisphosphonates, oral anticoagulants or anticonvulsants.
- Patient have or have had cancer of the upper aerodigestive tract treated by radiotherapy.
- Patient taking a steroidal or non-steroidal anti-inflammatory, anti-cancer or immunosuppressive chemotherapy in the last 6 months.
- Patient monitoring considered difficult by the investigator.
- Patient with poor oral hygiene incompatible with oral surgery.
- Patients with periodontal disease unstabilized
- Patient with oral dermatitis or adverse occlusion.
- Patient with an acute or chronic infection of the surgical site (osteomyelitis).
- Patient with a known allergy to collagen
- Patient with autoimmune disease
- Patient with a linguistic or mental incapacity to understand information
- Patient younger than 45 years old
- Patient trust under curatorship or judicial protection
- Patients aged over 45 premenopausal.
- Patient participating in another clinical study.
Trial locations and contacts
1 site in 1 country.
About this study
The main problem of using xenogenic bone in sinus floor elevation is the slow rate of absorption, which gives the percentages of vital bone low (20 to 30% depending on the study) in which the dental implant will be positioned However, osseointegration of the implant can be achieved only in vital bone. Enamel Matrix Derivative, through their angiogenic and osteogenic properties known, could promote bone healing during surgery sinus floor elevation by increasing the percentage of vital bone reformed, when added to xenografts.
- Being tested
- 7 patients will be recuting to received EMDOGAIM in left side, 7 patients will be recuting to received EMDOGAIM in right side
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
7 patients will be recuting to received EMDOGAIM in left sideOther
7 patients will be recuting to received EMDOGAIM in right sideOther
| Study group | Role | What they receive |
|---|---|---|
| right control | Other | the patient is his own control The right side will be treated as normal while the left side will also receive the emdogaim Receives: Other: 7 patients will be recuting to received EMDOGAIM in left side |
| left control | Other | the patient is his own control The left side will be treated as normal while the right side will also receive the emdogaim Receives: Other: 7 patients will be recuting to received EMDOGAIM in right side |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of vital bone obtained within the grafted site
Measured: evaluated six month after dental surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2013 (estimated)
- Study start6 Jun 2014
- Primary completion12 Apr 2017
- Study completion12 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient Who is Requiring Bilateral Sinus Floor Elevation and Necessity of Dental SurgeryStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01870960
- Sponsor's protocol ID
- 13-PP-01
- Acronym
- EMDOGAIM
- Status last verified
- Nov 2023
- First submitted
- 30 May 2013
- Last updated
- 14 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maxillary Sinus Floor Augmentation With Bioss® and Enamel Matrix Derivative: Evaluation of Osteogenic Properties
- ClinicalTrials.gov ID
- NCT01870960
- Acronym / sponsor ID
- EMDOGAIM / 13-PP-01
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 6 Jun 2014 (actual)
- Primary completion
- 12 Apr 2017 (actual)
- Study completion
- 12 Apr 2017 (actual)
- First posted
- 6 Jun 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 main problem of using xenogenic bone in sinus floor elevation is the slow rate of absorption, which gives the percentages of vital bone low (20 to 30% depending on the study) in which the dental implant will be positioned However, osseointegration of the implant can be achieved only in vital bone. Enamel Matrix Derivative, through their angiogenic and osteogenic properties known, could promote bone healing during surgery sinus floor elevation by increasing the percentage of vital bone reformed, when added to xenografts.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| right control | Other | Other: 7 patients will be recuting to received EMDOGAIM in left sidethe patient is his own control The right side will be treated as normal while the left side will also receive the emdogaim |
| left control | Other | Other: 7 patients will be recuting to received EMDOGAIM in right sidethe patient is his own control The left side will be treated as normal while the right side will also receive the emdogaim |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients > 45 years, postmenopausal women (ie with amenorrhea for more than a year).
- Subject requiring bilateral sinus floor elevation, in order to place two implants in grafted side.
- patients smoking less than 10 cigarettes per day
- patients having read and understood the information note on the study and signed the informed consent form.
- patients affiliated to the social security system.
Key exclusion criteria (22 listed)
- Patient with absolute contra-indication for dental surgery: valvular heart disease at risk of infectious endocarditis, recent myocardal (≤ 12 months), organ transplants, recent placement of a coronary stent (≤ 12 months), transient ischemic attacks recurrent, cardiovascular instability, uncontrolled epilepsy, rheumatic fever.
- Patient with metabolic bone disease (Paget's disease, osteomalacia, osteogenesis imperfecta)
- Patient with an ASA score ≥ 3.
- Patient with absolute contra-indication to dental surgery
- Patient with severe hematologic 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 |
|---|---|---|
| 7 patients will be recuting to received EMDOGAIM in left side | Other | right control |
| 7 patients will be recuting to received EMDOGAIM in right side | Other | left control |
Primary outcome
Percentage of vital bone obtained within the grafted site
Time frame: evaluated six month after dental surgery
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 14 Nov 2023.
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 study testing 7 patients will be recuting to received EMDOGAIM in left side and 7 patients will be recuting to received EMDOGAIM in right side in people with Patient Who is Requiring Bilateral Sinus Floor Elevation and Necessity of Dental Surgery, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
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 22 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 14 Nov 2023. 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 France. 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?
Percentage of vital bone obtained within the grafted site (time frame: evaluated six month after dental 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 14 Nov 2023.