BridgeMD
New treatment option for Sinus Tract
Official title SINUS FLOOR WITH OSSEODENSIFICATION OR LATERAL WINDOW
ClinicalTrials.gov ID: NCT06123221
What this study is testing
- What it's testing
- This study will compare patient-reported outcomes, as well as the type and incidence of complications, and bone marginal loss after 12 months in implants installed using the transcrestal approach (tSFE) with an osseodensification system (performed according to the protocol by Huwais et al. 2018), or installed simultaneously using the lateral window technique (lSFE) with sinus lift.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- Maxillary sinuses that have residual bone height between at least 3 mm and 5 mm;
- Width of the residual bone ridge that allows the insertion of an implant with a diameter of 4 mm;
- Tomographic thickness of Schneider's membrane with a maximum of 5 mm in the region to be operated;
- Residual ridge with ≥2 mm of medullary bone in the bucco-palatal direction, with a 1/1 ratio of medullary and cortical bone to achieve predictable...
- Patients with adequate interarch space for placement of the prosthetic crown;
You likely can't join if
- \- Those with sinus pathology;
- Heavy smokers (more than 10 cigarettes a day);
- Those with a history of head and neck radiotherapy;
- Those who have already undergone bone augmentation in any of the targeted surgical areas;
- Immunodeficiency of any nature;
- Emotional instability and psychiatric problems;
See the full eligibility criteria
- Maxillary sinuses that have residual bone height between at least 3 mm and 5 mm;
- Width of the residual bone ridge that allows the insertion of an implant with a diameter of 4 mm;
- Tomographic thickness of Schneider's membrane with a maximum of 5 mm in the region to be operated;
- Residual ridge with ≥2 mm of medullary bone in the bucco-palatal direction, with a 1/1 ratio of medullary and cortical bone to achieve predictable plastic expansion;
- Patients with adequate interarch space for placement of the prosthetic crown;
- Good physical health status (ASA1 and ASA2, according to the Physical Status Classification System - American Society of Anesthesiologists);
- At least 6 months since the last tooth loss in the region to be operated;
- \- Those with sinus pathology;
- Heavy smokers (more than 10 cigarettes a day);
- Those with a history of head and neck radiotherapy;
- Those who have already undergone bone augmentation in any of the targeted surgical areas;
- Immunodeficiency of any nature;
- Emotional instability and psychiatric problems;
- Pregnancy;
- Current use of oral bisphosphonates or history of using injectable bisphosphonate;
- Patients with active periodontitis defined by the presence of subgingival bleeding greater than 10%;
- Documented allergy to drugs or dental materials involved in the experimental protocol.
The study team makes the final eligibility decision.
Where it's taking place
- Porto Alegre, Rio Grande do Sul, Brazil
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Porto Alegre, Rio Grande do Sul, Brazil. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.