Comparing two methods for dental implant placement in the maxilla
COMPARISON OF IMPLANT INSTALLATION USING THE TRANSCRESTAL APPROACH WITH OSSEODENSIFICATION OR THE LATERAL WINDOW TECHNIQUE WITH SINUS LIFT: A RANDOMIZED CONTROLLED TRIAL.
This study is testing two different ways to place dental implants in people with limited bone height in the upper jaw to see which method leads to better patient experiences and fewer complications after a year.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 38 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Federal University of Rio Grande do Sul Academic / other |
| Locations | 1 site (Porto Alegre, Rio Grande do Sul) |
| Trial ID | NCT06123221 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare patient-reported outcomes, complication rates, and bone marginal loss after 12 months between two techniques for dental implant placement in patients with limited bone height in the posterior maxilla. The first technique is the transcrestal approach using osseodensification, while the second is the lateral window technique with sinus lift. The study will involve a randomized, controlled design with participants over 18 years old who have experienced single tooth loss and meet specific bone criteria. Both methods will utilize synthetic biomaterials to support the implants.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with single tooth loss in the posterior maxilla and a residual bone height of 3 to 5 mm.
Not a fit: Patients with sinus pathology, heavy smokers, or those with a history of head and neck radiotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve dental implant outcomes for patients with limited bone height.
How similar studies have performed: Other studies have shown promising results with similar techniques, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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; Exclusion Criteria: * \- 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.
Where this trial is running
Porto Alegre, Rio Grande do Sul
- Alex Haas — Porto Alegre, Rio Grande do Sul, Brazil (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.