Clinical trial NCT05377710: Evaluation of the Safety and Performance of Glycobone in Sinus Lift
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sinus Elevation
Bone Substitute
Lead sponsor: SILTISS
Sponsor class: INDUSTRY
First posted: 2022-05-17
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: human
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

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
4. 4. 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)

Primary outcomes:
measure: Evaluation of the success rate of the implantation at 6 months
timeFrame: 6 months after implantation
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: SILTISS
name: Jean PAUFIQUE
role: STUDY_DIRECTOR
affiliation: University Hospital, Bordeaux
name: Sylvain CATROS
role: PRINCIPAL_INVESTIGATOR
References: