Sinus ElevationSLNCT05377710
Evaluation of the Safety and Performance of Glycobone in Sinus Lift
A study testing sinus lift with lateral approach in people with Sinus Elevation and Bone Substitute, run by SILTISS.
Trial summary
Multicentre, interventional, longitudinal, open-label study conducted in France, evaluating the clinical performance and safety of Glycobone® as a bone filling material in the context of a lateral approach sinus lift on 40 patients with dental implant placement. Implant placement took place 6 months after bone filling. Read more about this study
- Who is it for?
- Ages 18 to 84 yearsHealthy volunteers can take part
- Conditions the study is for
- Sinus Elevation, Bone Substitute
- What is being tested?
- sinus lift with lateral approach
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 16 May 2022to 16 May 2022
- 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 84 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1. Adult patient, male or female, aged 18-84 years at the time of signing the consent form
- 2. Patient who has been informed and has signed consent prior to any procedure related to the investigation 3. Patient requiring a dental implant procedure:
- Implant project associated with at least one lateral approach sinus lift due to sub-sinus bone height < 5 mm, without full bridge
- Associated with a bone filling
- With implant placement deferred to approximately 6 months within the limit of a maximum of 3 implants in the framework of the investigation 4. Availability of a cone beam with radiological guide less than 3 months old 5. Patient covered by a health insurance plan.
Who cannot join
- 3 months or less old tooth extraction (≤ 3 months)
- Sinus lift project requiring placement of all contralateral implants at the same time (i.e. 2 sinus lift projects associated with a full bridge)
- Contralateral sinus lift of the site to be included performed within 3 months prior to inclusion
- 4. Patient's general condition does not allow the investigator to perform the investigative procedures
- Pregnant or breastfeeding patient at the time of the sinus lift and filling procedure (D0)
- Patient with a concomitant ENT infection that may interfere with the investigative procedures
Show all 13Show fewer
- Patient with an uncontrolled chronic condition that may interfere with investigative procedures
- Patient on VKA with INR >4, biphosphonates, denosumab or having been treated with radiotherapy in the study area
- Patient unable to receive any type of analgesic during the investigation
- Patient allergic to any of the components of Glycobone®.
- Patient participating or having participated in another drug or medical device clinical trial within 30 days prior to inclusion in this study
- Patient considered by the investigator to be non-compliant with study procedures
- Patient deprived of liberty by court or administrative order or under legal protection (e.g. guardianship)
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Multicentre, Interventional, Longitudinal, Open-label Study Conducted in France Evaluating the Clinical Performance and Safety of Glycobone® as a Bone Filler in a Lateral Sinus Lift Setting
Multicentre, interventional, longitudinal, open-label study conducted in France, evaluating the clinical performance and safety of Glycobone® as a bone filling material in the context of a lateral approach sinus lift on 40 patients with dental implant placement. Implant placement took place 6 months after bone filling.
Read the detailed description
A multicentre, interventional, longitudinal, open-label, prospective, pilot exploratory study of first-in-man administration in France, evaluating the clinical performance, safety and bone filling properties of Glycobone® during a lateral sinus lift procedure with deferred implant placement.
The study will follow a panel of 40 patients for 9 months in three consecutive stages:
Stage 1: Inclusion of a group of up to 5 patients Stage 2: If safety validation in stage 1 is confirmed: Inclusion of a group of 15 additional patients (maximum) Step 3: If safety validation in step 2 is confirmed: Inclusion of a group of 20 additional patients.
- Conditions
- Sinus Elevation, Bone Substitute
- Being tested
- sinus lift with lateral approach
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sinus lift with lateral approachProcedure or surgery
Also called sinus elevation
Maxillary sinus floor augmentation or sinus lift is a surgical procedure, which provides a solution to the problem of sinus bone loss (too thin), and thus increases the thickness of the bone for immediate or subsequent implant placement in the premolars and molars (4). It consists of the elevation of the sinus mucosa that lines the maxillary sinus. The space thus freed will be filled with a bone filling material
| Study group | Role | What they receive |
|---|---|---|
| Glycobone | Experimental | Patients will be implanted at T0 with Glycobone Receives: Procedure: sinus lift with lateral approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the success rate of the implantation at 6 months
The primary endpoint of the investigation is the success rate at M6 defined as the number of successfully placed implants (with sufficient bone formation judged by the implantologist and an implant judged to be stable) compared to the total number of implants planned to be placed at the beginning of the treatment
Measured: 6 months after implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2022
- Study start16 May 2022 (estimated)
- Primary completion16 May 2022 (estimated)
- Study completion16 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sinus ElevationStudies 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
- Model description
- human
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SILTISS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jean PAUFIQUE, Study director, SILTISSSylvain CATROS, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05377710
- Sponsor's protocol ID
- 2020-A02457-32
- Acronym
- SL
- Status last verified
- May 2022
- First submitted
- 5 May 2022
- Last updated
- 17 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It is a private study belonging to SILTISS; the data will not be transmitted to other scientists but will remain within SILTISS to be valorised
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentre, Interventional, Longitudinal, Open-label Study Conducted in France Evaluating the Clinical Performance and Safety of Glycobone® as a Bone Filler in a Lateral Sinus Lift Setting
- ClinicalTrials.gov ID
- NCT05377710
- Acronym / sponsor ID
- SL / 2020-A02457-32
- Conditions
- Sinus Elevation, Bone Substitute
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- SILTISSIndustry (pharma, biotech, devices)
- Study start
- 16 May 2022 (estimated)
- Primary completion
- 16 May 2022 (estimated)
- Study completion
- 16 May 2022 (estimated)
- First posted
- 17 May 2022 (actual)
- 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.
Multicentre, interventional, longitudinal, open-label study conducted in France, evaluating the clinical performance and safety of Glycobone® as a bone filling material in the context of a lateral approach sinus lift on 40 patients with dental implant placement. Implant placement took place 6 months after bone filling.
Detailed description
A multicentre, interventional, longitudinal, open-label, prospective, pilot exploratory study of first-in-man administration in France, evaluating the clinical performance, safety and bone filling properties of Glycobone® during a lateral sinus lift procedure with deferred implant placement.
The study will follow a panel of 40 patients for 9 months in three consecutive stages:
Stage 1: Inclusion of a group of up to 5 patients Stage 2: If safety validation in stage 1 is confirmed: Inclusion of a group of 15 additional patients (maximum) Step 3: If safety validation in step 2 is confirmed: Inclusion of a group of 20 additional patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- human
| Arm | Type | Receives |
|---|---|---|
| Glycobone | Experimental | Procedure: sinus lift with lateral approachPatients will be implanted at T0 with Glycobone |
Who may qualify
- Ages
- 18 to 84 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 1. Adult patient, male or female, aged 18-84 years at the time of signing the consent form
- 2. Patient who has been informed and has signed consent prior to any procedure related to the investigation 3. Patient requiring a dental implant procedure:
- Implant project associated with at least one lateral approach sinus lift due to sub-sinus bone height < 5 mm, without full bridge
- Associated with a bone filling
- With implant placement deferred to approximately 6 months within the limit of a maximum of 3 implants in the framework of the investigation 4. Availability of a cone beam with radiological guide less than 3 months old 5. Patient covered by a health insurance plan.
Key exclusion criteria (13 listed)
- 3 months or less old tooth extraction (≤ 3 months)
- Sinus lift project requiring placement of all contralateral implants at the same time (i.e. 2 sinus lift projects associated with a full bridge)
- Contralateral sinus lift of the site to be included performed within 3 months prior to inclusion
- 4. Patient's general condition does not allow the investigator to perform the investigative procedures
- Pregnant or breastfeeding patient at the time of the sinus lift and filling procedure (D0)
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 lift with lateral approachAlso: sinus elevationMaxillary sinus floor augmentation or sinus lift is a surgical procedure, which provides a solution to the problem of sinus bone loss (too thin), and thus increases the thickness of the bone for immediate or subsequent implant placement in the premolars and molars (4). It consists of the elevation of the sinus mucosa that lines the maxillary sinus. The space thus freed will be filled with a bone filling material | Procedure or surgery | Glycobone |
Primary outcome
Evaluation of the success rate of the implantation at 6 months
Time frame: 6 months after implantation
The primary endpoint of the investigation is the success rate at M6 defined as the number of successfully placed implants (with sufficient bone formation judged by the implantologist and an implant judged to be stable) compared to the total number of implants planned to be placed at the beginning of the treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2022.
- Individual participant dataSharing planned: No. It is a private study belonging to SILTISS; the data will not be transmitted to other scientists but will remain within SILTISS to be valorised
Related trials for Sinus Elevation
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Assessment of a New Enhanced Xenograft in Open Maxillary Sinus Augmentation
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Clinical, Radiographic, Histological, and Patient-reported/ Experience Outcome Measures of Endoscopically-monitored Graftless Transcrestal Sinus Floor Elevation With Simultaneous Multiple Implant Placement Using Osseodensification(OD) Versus Osteotomes (OT) in Subsinus Bone Height of 4-5 mm: An RCT
Osseodensification Drilling Technique
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Evaluation of Lateral Sinus Floor Elevation Using Xenograft Versus L-PRF Block Combined With Xenograft
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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.
Jean PAUFIQUE study director
SILTISS
Sylvain CATROS principal investigator
University Hospital, Bordeaux
Questions about this trial
What is this clinical trial studying?
A study testing sinus lift with lateral approach in people with Sinus Elevation and Bone Substitute, run by SILTISS.
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 13 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 17 May 2022. 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?
Contact Sandrine AUGET (+33 (0)5 55 84 58 40, s.auget@siltiss.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the success rate of the implantation at 6 months (time frame: 6 months after implantation). 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 17 May 2022.