Advanced X-Ray Technology for Dental Implants
Palo Alto (17 mi)Overseen byCharles Powell, DDS, MS
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: N/A
Recruiting
Sponsor: The University of Texas Health Science Center at San Antonio
No Placebo Group
Approved in 3 jurisdictions
Trial Summary
What is the purpose of this trial?The goal of this clinical study is to learn if cone beam computed tomography (CBCT) or 3-dimensional x-ray can help to let the investigator know if dental implant placement can be done after performing closed sinus surgery.
The study will look at the structure of your gum where the implant will be placed after performing the surgery using 3-D x-ray and compare that to how the structure of your gum looks 6 months later.
The 3-D imaging will happen after standard of care surgery to prepare your gum for an implant and then 6 months later to verify that the site is ready for the implant.
Is Closed Sinus Augmentation a promising treatment for dental implants?Yes, Closed Sinus Augmentation is a promising treatment for dental implants. It is less invasive, less time-consuming, and can increase bone height, making it easier to place dental implants successfully. Techniques like the sinus balloon and Smart Lift have shown positive results, with successful implant placement and minimal complications.134810
What safety data is available for advanced X-ray technology in dental implants?The safety data for transcrestal sinus lift procedures, which are related to advanced X-ray technology for dental implants, indicate that these procedures are well-established and reliable. The Smart Lift technique, a minimally invasive method, showed no complications during or after surgery, with implant stability maintained for up to 1 year. Additionally, a study on grafted bone remodeling suggests that while the procedure is reliable, the stability of grafted bone height can be influenced by clinical factors. Another study highlights the importance of preoperative and perioperative care to prevent complications like sinusitis in high-risk patients.13789
Do I have to stop taking my current medications?The trial does not specify if you need to stop taking your current medications, but you cannot participate if you use medications known to affect bone metabolism.
What data supports the idea that Advanced X-Ray Technology for Dental Implants is an effective treatment?The available research shows that Advanced X-Ray Technology for Dental Implants, specifically transcrestal sinus augmentation, is effective. One study with a 5-year follow-up found that this technique is well-established and effective for implant placement. Another study with a 1-year follow-up highlighted the advantages of immediate implant insertion with this method. A case report described a minimally invasive technique that resulted in stable implants and no complications for up to a year. Additionally, a study with a 5-year follow-up showed that the technique is effective in terms of implant survival and minimal complications. Overall, these studies suggest that this treatment is reliable and beneficial for patients.12568
Eligibility Criteria
This trial is for individuals needing dental implants who require closed sinus surgery to prepare the gum. Participants must be suitable for standard of care surgery and willing to undergo 3-D x-rays immediately after surgery and six months later.Inclusion Criteria
I need a sinus lift for dental implants and I'm between 18-85.
I have at least 5mm of bone below the sinus in my upper jaw.
Exclusion Criteria
My diabetes is not well-controlled, with an HbA1c over 7.1.
I have a condition affecting my maxillary sinus.
Treatment Details
The study tests if a low volume CBCT, or 3-dimensional x-ray, can accurately assess the readiness of the gum structure for dental implant placement after closed sinus augmentation, both immediately post-surgery and at a six-month follow-up.
1Treatment groups
Experimental Treatment
Group I: Closed sinus augmentation with Calcium Phosphosilicate PuttyExperimental Treatment1 Intervention
Use of CBCT immediately post-operatively after placement of Calcium Phosphosilicate Putty used as standard of care for closed sinus augmentation and at 6 months after surgery.
Closed Sinus Augmentation is already approved in European Union, United States, Canada for the following indications:
🇪🇺 Approved in European Union as Closed Sinus Augmentation for:
- Insufficient bone height for dental implant placement in the posterior maxilla
🇺🇸 Approved in United States as Closed Sinus Augmentation for:
- Tooth loss and bone resorption in the posterior upper jaw requiring dental implant placement
🇨🇦 Approved in Canada as Closed Sinus Augmentation for:
- Vertical bone augmentation in the posterior segment of the edentulous maxilla for dental implant placement
Find a clinic near you
Research locations nearbySelect from list below to view details:
The University of Texas Health Science Center at San AntonioSan Antonio, TX
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Who is running the clinical trial?
The University of Texas Health Science Center at San AntonioLead Sponsor
References
Minimally invasive technique for transcrestal sinus floor elevation: a case report. [2021]The present report describes a minimally invasive technique for transcrestal sinus floor elevation, namely the Smart Lift technique, which is based on the controlled use of drills and osteotomes. The rationale of this technique is to provide predictable vertical bone augmentation into the sinus cavity by (1) using the existing residual bone as a viable graft and (2) limiting the incidence of membrane perforation and postsurgery morbidity. Surgical steps of the procedure are thoroughly illustrated by means of a paradigmatic case. The Smart Lift procedure was compatible with sinus floor elevation and implant stability for up to 1 year following surgery. No complications occurred during or after surgery. On periapical radiographs, a radiopaque area corresponding to the augmented sinus floor was present above the apical portion of the implant.
Radiographic analysis of a transalveolar sinus-lift technique: a multipractice retrospective study with a mean follow-up of 5 years. [2014]Various sinus-lift techniques have been described in the literature. The aim of this retrospective study is to evaluate the efficacy of a transalveolar sinus-lift technique in terms of implant survival, marginal bone loss, and complications.
Transcrestal sinus lift and implant placement using the sinus balloon technique. [2021]A description is made of transcrestal sinus lift using the sinus balloon technique, evaluating the bone height achieved and implant success one year after prosthetic loading.
The incidence of maxillary sinus membrane perforation during endoscopically assessed crestal sinus floor elevation: a pilot study. [2022]Transcrestal sinus membrane elevation is a surgical procedure performed to increase the bone volume in the maxillary sinus cavity. Because of visual limitations, the potential for maxillary sinus membrane perforations may be greater than with the lateral approach technique. The aim of this study was to macroscopically investigate ex vivo the occurrence of sinus membrane perforation during surgery using 3 transcrestal sinus floor elevation methods. Twenty fresh human cadaver heads, with 40 intact sinuses, were used for simultaneous sinus membrane elevation, placement of graft material, and dental implants. Real-time sinus endoscopy, periapical digital radiographs, and cone-beam computerized tomography (CBCT) images were subsequently used to evaluate the outcome of each surgical procedure. Perforation rates for each of the 3 techniques were then compared using a significance level of P
Transcrestal Sinus Floor Augmentation by Sequential Drilling and the Use of Plasma Rich in Growth Factors. [2019]There is a paucity of studies that evaluate the treatment outcomes of transcrestal sinus elevation performed without using osteotomes. This study aims to evaluate the 4-year survival of short dental implants placed following transcrestal sinus elevation performed with a frontal cutting drill and to measure the marginal bone stability.
Transcrestal sinus floor augmentation with immediate implant placement applied in three types of fresh extraction sockets: A clinical prospective study with 1-year follow-up. [2018]Immediate implant insertion and transcrestal sinus augmentation both can provide a lot of advantages for patients and clinicians.
A Successful Treatment Regimen for the Prevention of Sinusitis after Maxillary Sinus Floor Elevation Surgery in a High-Risk Case. [2020]Maxillary sinus floor elevation (sinus lift) is a widely recognized dental-surgical approach for dental implant placement. However, for an otorhinolaryngological high-risk patient with severe anatomic-structural impairments of the maxillary sinus drainage pathway, surgical intervention is recommended before sinus lift to avoid postsinus lift maxillary sinusitis. Here, we show a case that postsinus lift maxillary sinusitis in such a high-risk patient was noninvasively prevented by the collaboration of otorhinolaryngologist and dentist. A 48-year-old Japanese male intended to undergo a sinus lift for dental implant placement by periodontist. Otorhinolaryngologist found septal deviation, concha bullosa, the presence of Haller cell, and nasal mucosal swelling by the nasal allergy, while no sinusitis and diagnosed him as a "high-risk case" for postsinus lift maxillary sinusitis. The patient was administered preoperative topical steroid and leukotriene receptor antagonist in addition to perioperative antibiotic prophylaxis so that his complication was noninvasively prevented. Thus, this case suggested that consultation from dentist to otorhinolaryngologist provides benefit to the patients who have been diagnosed as "high-risk case" for postsinus lift maxillary sinusitis.
Flapless Localised Management of Sinus Floor (LMSF) for trans-crestal sinus floor augmentation and simultaneous implant placement. A retrospective non-randomized study: 5-year of follow-up. [2022]Trans-crestal sinus lift procedures are well established.
Grafted bone remodeling following transcrestal sinus floor elevation: A cone-beam computed tomography study. [2021]Transcrestal sinus floor elevation is a reliable procedure when additional bone height is needed for maxillary implant placement. However, the grafted bone undergoes remodeling and the dimensional stability of grafted bone height may be affected by several clinical factors, including graft material, sinus anatomy and the morphology of grafted space.
Different techniques in transalveolar maxillary sinus elevation: A literature review. [2022]Dental implant treatment in the posterior maxilla encounters bone quality and quantity problems. Sinus elevation is a predictable technique to overcome height deficiency in this area. Transalveolar sinus elevation is a technique that is less invasive and less time-consuming, first introduced for ridges with at least 5 mm of bone height. Many modifications and innovative equipment have been introduced for this technique. This review aimed to explain the modifications of this technique with their indications and benefits. An exhaustive search in PubMed Central and Scopus electronic databases was performed until December 2020. Articles were selected that introduced new techniques for the transalveolar maxillary sinus approach that had clinical cases with full texts available in the English language. Finally, twenty-six articles were included. The data were categorized and discussed in five groups, including expansion-based techniques, drill-based techniques, hydraulic pressure techniques, piezoelectric surgery, and balloon techniques. The operator's choice for transalveolar approach techniques for sinus floor elevation can be based on the clinician's skill, bone volume, and access to equipment. If possible, a technique with simultaneous implant placement should be preferred.