25 Participants Needed

Advanced X-Ray Technology for Dental Implants

CP
Overseen ByCharles Powell, DDS, MS
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: The University of Texas Health Science Center at San Antonio
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a special 3-D x-ray, called cone beam computed tomography (CBCT), can assist doctors in deciding the safety of placing dental implants after Closed Sinus Augmentation surgery. The study focuses on individuals needing sinus surgery to prepare for these implants. Researchers will use the 3-D x-ray immediately after surgery and again six months later to monitor healing. Suitable candidates for this trial include those needing dental implants with sufficient bone below their sinus, excluding individuals with certain health issues like uncontrolled diabetes or tobacco use. As an unphased trial, this study allows participants to contribute to innovative research that could enhance future dental procedures.

Will 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 that affect bone metabolism.

What prior data suggests that this advanced x-ray technology is safe for dental implant procedures?

Research has shown that using a special calcium putty in sinus surgery is generally safe and well-tolerated. Studies have found that this putty, used in procedures to lift the sinus, does not cause major health problems. In one review, researchers noted that patients who underwent this procedure with the putty experienced good results with few side effects.

Another study examined the use of this putty in sinus surgery and found that patients did not experience serious negative reactions. The putty aids bone growth after surgery, which is important for placing dental implants. Overall, the treatment appears safe and effective for individuals needing sinus surgery before receiving dental implants.12345

Why are researchers excited about this trial?

Researchers are excited about the use of Calcium Phosphosilicate Putty for closed sinus augmentation because it introduces a unique way to support bone regeneration. Unlike other treatments that may rely on more invasive grafting techniques, this putty offers a minimally invasive option that can be applied directly and easily. Additionally, with the aid of advanced X-ray technology, known as Cone Beam Computed Tomography (CBCT), the effectiveness of the treatment can be precisely monitored immediately post-surgery and again after six months. This combination of innovative materials and cutting-edge imaging could lead to better outcomes and faster recovery times for patients needing dental implants.

What evidence suggests that this advanced x-ray technology is effective for dental implants?

Research has shown that calcium phosphosilicate putty works well in sinus augmentation, a procedure that prepares the jaw for dental implants. In this trial, participants will undergo closed sinus augmentation with calcium phosphosilicate putty. One study found that this material helps new bone grow in the sinus area, creating a strong base for dental implants. Another study reported positive results, highlighting the putty's ability to encourage bone growth and stability. These findings suggest that using this putty in sinus surgeries can effectively prepare the jaw for future dental implants.13456

Who Is on the Research Team?

CP

Charles Powell, DDS, MS

Principal Investigator

The University of Texas Health Science Center at San Antonio

Are You a Good Fit for This Trial?

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

Individuals who are normal healthy or have a diabetes diagnosis with a current HbA1c (glycated glucose) < 7.0
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.
See 2 more

Exclusion Criteria

I am taking medication that affects bone health.
Alcoholism or other recreational drugs
My condition affects how my bones use nutrients.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgical Procedure

Participants undergo sinus grafting and dental implant placement, followed by a three-dimensional x-ray

1 day
1 visit (in-person)

Follow-up

Participants are monitored for changes in bone volume and undergo a three-dimensional x-ray at six months post-surgery

6 months
1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Closed Sinus Augmentation
Trial Overview 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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Closed sinus augmentation with Calcium Phosphosilicate PuttyExperimental Treatment1 Intervention

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:
🇺🇸
Approved in United States as Closed Sinus Augmentation for:
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Approved in Canada as Closed Sinus Augmentation for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

The University of Texas Health Science Center at San Antonio

Lead Sponsor

Trials
486
Recruited
92,500+

Published Research Related to This Trial

In a study using 20 human cadaver heads, no significant differences in sinus membrane perforation rates were found among three different transcrestal sinus floor elevation techniques, indicating that the risk of perforation is similar regardless of the method used.
Real-time endoscopy revealed that perforations were more frequently noted during implant placement compared to graft insertion, although this difference was not statistically significant, highlighting the importance of careful monitoring throughout the procedure.
The incidence of maxillary sinus membrane perforation during endoscopically assessed crestal sinus floor elevation: a pilot study.Garbacea, A., Lozada, JL., Church, CA., et al.[2022]
The Smart Lift technique for transcrestal sinus floor elevation is a minimally invasive method that effectively uses existing bone to augment the sinus cavity, reducing the risk of complications such as membrane perforation.
In a case study, the Smart Lift procedure demonstrated successful implant stability and no complications for up to 1 year post-surgery, with clear radiographic evidence of bone augmentation.
Minimally invasive technique for transcrestal sinus floor elevation: a case report.Trombelli, L., Minenna, P., Franceschetti, G., et al.[2021]
In a case involving a 48-year-old male with severe anatomical issues in the maxillary sinus, a collaborative approach between an otorhinolaryngologist and a dentist successfully prevented postsinus lift maxillary sinusitis through noninvasive methods.
The patient received preoperative topical steroids, a leukotriene receptor antagonist, and perioperative antibiotic prophylaxis, highlighting the importance of addressing underlying sinus conditions before dental procedures to enhance safety and efficacy.
A Successful Treatment Regimen for the Prevention of Sinusitis after Maxillary Sinus Floor Elevation Surgery in a High-Risk Case.Suzuki-Yamazaki, M., Takahashi, K., Takada, S., et al.[2020]

Citations

Evolving Techniques and Trends in Maxillary Sinus Lift ...This review explores various aspects of maxillary sinus augmentation, ranging from traditional methods to evolving contemporary techniques.
Study Details | Closed Sinus Augmentation With a Calcium ...The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure.
A clinical and radiographic case series of implants placed ...The aim of the present case series was to evaluate a minimally invasive transalveolar sinus elevation technique utilizing calcium phosphosilicate (CPS) putty ...
Clinical and radiological outcomes of osseodensification ...The aim of the present study was to evaluate the clinical and radiological effectiveness of transcrestal sinus elevation and simultaneous implant placement
Efficacy of Calcium Phosphosilicate (CPS) Putty As ...This study evaluated the efficacy of Calcium Phosphosilicate (CPS) putty as an alloplastic bioactive graft material for sinus augmentation procedures.
(PDF) Minimally Invasive Transalveolar Sinus AugmentationThis method utilizes the calcium phosphosilicate putty for hydraulic sinus membrane elevation along with osseodensification drills.
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