Morbidity following transcrestal and lateral sinus floor elevation: A randomized trial.
Roberto Farina, Giovanni Franceschetti, Domenico Travaglini...
https://pubmed.ncbi.nlm.nih.gov/29992594Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
ID06123221
Comparison of Implant Placement Using the Transcrestal Osseodensification Approach or the Lateral Window Sinus Lift Technique: A Randomized Controlled Trial
Led by Federal University of Rio Grande do Sul · Updated on 2023-11-08
38
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are comparing two methods for placing dental implants in adults with a single missing tooth in the back upper jaw, where the remaining bone height is between 3 and 5 mm. The study evaluates patient-reported outcomes, complication types and rates, and bone loss around the implants over 12 months. This randomized, controlled clinical trial uses a blinded approach to monitor and compare the two surgical techniques. One group will receive implants using the transcrestal approach with osseodensification burs, which prepare the bone using a special counterclockwise drilling method combined with synthetic bone materials. The other group will receive implants installed with the lateral window technique, where a window is made in the sinus wall, filled with similar synthetic biomaterial, and covered with a membrane. Both groups receive simultaneous implant placement during their respective sinus lift procedures. Participants will report pain levels daily for two weeks after surgery using a visual scale, and track medication use. Post-treatment, cone beam tomography scans will measure bone levels around the implant immediately after prosthetic rehabilitation and again at six and twelve months. Patient quality of life factors such as social and professional isolation, physical appearance, speech, eating habits, and sleep will be assessed through questionnaires during the initial two weeks. Data analysis will compare outcomes between the two techniques over time.
CONDITIONS
Brief Title
SINUS FLOOR WITH OSSEODENSIFICATION OR LATERAL WINDOW
Who Can Participate
Age: 18Years +
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Maxillary sinuses with residual bone height between 3 mm and 5 mm
- Residual bone ridge wide enough for a 4 mm diameter implant
- Thickness of Schneider's membrane up to 5 mm in the surgical area
- Residual ridge with at least 2 mm of medullary bone in the bucco-palatal direction with balanced medullary and cortical bone
- Adequate space between jaws for prosthetic crown placement
- Good physical health (ASA1 or ASA2 status)
- At least 6 months since last tooth loss in the surgical area
You will not qualify if you...
- Sinus pathology
- Heavy smoking (more than 10 cigarettes per day)
- History of head and neck radiotherapy
- Previous bone augmentation in the surgical area
- Any immunodeficiency
- Emotional instability or psychiatric problems
- Pregnancy
- Current or past use of oral or injectable bisphosphonates
- Active periodontitis with more than 10% subgingival bleeding
- Allergy to drugs or dental materials used in the study protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Single treatment session
Participants receive sinus floor elevation with either osseodensification and concomitant implant installation or lateral window and concomitant implant installation.
1 procedure visit (in-person)
Follow-up
Duration - 14 days
Participants are monitored for pain levels and medication use for two weeks after the procedure.
Daily assessments for 14 days
Trial Site Locations
Total: 1 location
1
Alex Haas
Porto Alegre, Rio Grande do Sul, Brazil, 90630080
Actively Recruiting
Loading map...
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Published Research Related To This Trial
A Multicenter Retrospective Clinical Study with Up-to-5-Year Follow-up Utilizing a Method that Enhances Bone Density and Allows for Transcrestal Sinus Augmentation Through Compaction Grafting.
Salah Huwais, Ziv Mazor, Andreas L Ioannou...
https://pubmed.ncbi.nlm.nih.gov/30427961Maxillary Sinus Floor Augmentation: a Review of Selected Treatment Modalities.
Thomas Starch-Jensen, Janek Dalsgaard Jensen
https://pubmed.ncbi.nlm.nih.gov/29142655Patient-reported outcomes of implant placement performed concomitantly with transcrestal sinus floor elevation or entirely in native bone.
Giovanni Franceschetti, Alessandro Rizzi, Luigi Minenna...
https://pubmed.ncbi.nlm.nih.gov/26749535Intraoperative and postoperative outcomes of sinus floor elevation using the lateral window technique versus the hydrodynamic transalveolar approach: a preliminary randomized controlled trial.
Miljana Bacevic, Yoann Compeyron, Geoffrey Lecloux...
https://pubmed.ncbi.nlm.nih.gov/33694027Patient's perception of recovery after osteotome-mediated sinus floor elevation with Bio-Oss collagen compared with no grafting material: a randomized single-blinded controlled trial.
Thomas Starch-Jensen, Niels Henrik Bruun
https://pubmed.ncbi.nlm.nih.gov/33748923To Drill or to Densify? Clinical Indications for the Use of Osseodensification.
Michael A Pikos, Richard J Miron
https://pubmed.ncbi.nlm.nih.gov/31067068A Novel Osseous Densification Approach in Implant Osteotomy Preparation to Increase Biomechanical Primary Stability, Bone Mineral Density, and Bone-to-Implant Contact.
Salah Huwais, Eric G Meyer
https://pubmed.ncbi.nlm.nih.gov/27741329