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Evaluation of the Safety and Performance of Glycobone in Sinus Lift

40 participantsStarted 2022-05-16

Plain-language 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.

Who can participate

Age range18 Years – 84 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

✕. 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
✕. 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

What they're measuring

Evaluation of the success rate of the implantation at 6 months

Timeframe: 6 months after implantation

Trial details

NCT IDNCT05377710

SponsorSILTISS

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-05-16

Contact for this trial

Sandrine AUGET

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

View on ClinicalTrials.gov More Sinus Elevation trials