Evaluation of the Safety and Performance of Glycobone in Sinus Lift

NCT05377710 | Unknown

• 1 other identifier: 2020-A02457-32
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Sinus Elevation; Bone Substitute

Outcome Measures

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

  6 months after implantation

Study Arms (1)

Glycobone

EXPERIMENTAL

Patients will be implanted at T0 with Glycobone

Procedure: sinus lift with lateral approach

Interventions

sinus lift with lateral approach PROCEDURE

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

Glycobone

Eligibility Criteria

• Age: 18 Years - 84 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)
• \. 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
• 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 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)

Sponsors & Collaborators

• SILTISS: lead

Study Officials

• Jean PAUFIQUE

  SILTISS

  STUDY DIRECTOR

• Sylvain CATROS

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sandrine AUGET

CONTACT

+33 (0)5 55 84 58 40; s.auget@siltiss.fr

Didier LETOURNEUR

CONTACT

+33 (0)5 55 84 58 40; didier.letourneur@siltiss.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: human

Study Record Dates

• First Submitted: May 5, 2022
• First Posted: May 17, 2022
• Study Start: May 16, 2022
• Primary Completion: May 16, 2022
• Study Completion: May 16, 2022
• Last Updated: May 17, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share