Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:28 PM
Ignite Modification Date:
2025-12-24 @ 5:28 PM
NCT ID:
NCT04811768
Eligibility Criteria:
Inclusion Criteria:
* at least one missing maxillary premolar or molar
* at least 7 mm crestal bone width confirmed by preoperative ConeBeam Tomography (CBCT)
* maximally 5 mm residual bone height at the sinus floor confirmed by preoperative ConeBeam Tomography (CBCT)
* full mouth plaque and bleeding scores (FMPS and FMBS) \<20%
* satisfactory patient compliance (e.g. to participate in follow-up procedures)
* signed informed consent.
Exclusion Criteria:
* clinically relevant diseases (e.g.: diabetes, rheumatism cancer)
* untreated periodontitis
* systemic steroid use
* bisphosphonate use
* acute or chronic inflammatory processes
* previous endoscopic sinus surgery
* previous sinus floor elevation
* GBR-treatment at the study site
* GTR-treatment at the study site
* tooth removal within 6 weeks prior to surgery
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT04811768
Study Brief:
Protocol Section:
NCT04811768