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Status unknownNCT05377710SLUpdated May 17, 2022

Evaluation of the Safety and Performance of Glycobone in Sinus Lift

An interventional study of sinus lift with lateral approach in Sinus Elevation and Bone Substitute, sponsored by SILTISS. Status unknown. Open to participants aged 18 Years to 84 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-05-17.

Sponsored by SILTISS · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
18 Years to 84 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Sinus Elevation
  • Bone Substitute
03

In context

Lead sponsor

This is the only study on the registry with SILTISS as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 84 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

    1. Adult patient, male or female, aged 18-84 years at the time of signing the consent form

      1. 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.

Exclusion criteria

Exclusion Criteria:

  1. 3 months or less old tooth extraction (≤ 3 months)
  2. Sinus lift project requiring placement of all contralateral implants at the same time (i.e. 2 sinus lift projects associated with a full bridge)
  3. Contralateral sinus lift of the site to be included performed within 3 months prior to inclusion
    1. Patient's general condition does not allow the investigator to perform the investigative procedures
  5. Pregnant or breastfeeding patient at the time of the sinus lift and filling procedure (D0)
  6. Patient with a concomitant ENT infection that may interfere with the investigative procedures
  7. Patient with an uncontrolled chronic condition that may interfere with investigative procedures
  8. Patient on VKA with INR >4, biphosphonates, denosumab or having been treated with radiotherapy in the study area
  9. Patient unable to receive any type of analgesic during the investigation
  10. Patient allergic to any of the components of Glycobone®.
  11. Patient participating or having participated in another drug or medical device clinical trial within 30 days prior to inclusion in this study
  12. Patient considered by the investigator to be non-compliant with study procedures
  13. Patient deprived of liberty by court or administrative order or under legal protection (e.g. guardianship)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Glycobone

    Patients will be implanted at T0 with Glycobone

    Procedure: sinus lift with lateral approach

Interventions

  • Proceduresinus lift with lateral approach

    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

    Also known as: sinus elevation

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 6 months after implantation

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: 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

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 17, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05377710
Lead sponsor
SILTISS
Responsible party
Sponsor
First posted
May 17, 2022
Start date
May 16, 2022 (estimated)
Primary completion
May 16, 2022 (estimated)
Completion
May 16, 2022 (estimated)
Last update
May 17, 2022

Study contacts

Sandrine AUGET
Contact
s.auget@siltiss.fr
+33 (0)5 55 84 58 40
Didier LETOURNEUR
Contact
didier.letourneur@siltiss.fr
+33 (0)5 55 84 58 40
Jean PAUFIQUE
study director · SILTISS
Sylvain CATROS
principal investigator · CHU Bordeaux

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2022. You cannot join it, but the record below documents what was studied.

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