CompletedPhase 4

Lateral Bony Wall Repositioning in Maxillary Sinus Floor Augmentation

Hungary40 participantsStarted 2017-03-01

Plain-language summary

The aim of the present prospective randomized controlled study is to clinically and histologically investigate the safety and efficacy of bony wall repositioning compared to rotary window preparation with membrane coverage in maxillary sinus floor augmentation.

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

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

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Duration of surgery

Timeframe: During smaxillary sinus augmentation

Trial details

NCT IDNCT04811768

SponsorSemmelweis University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-05-30

View on ClinicalTrials.gov More Maxillary Sinus Augmentation trials

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

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