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

Trial Summary

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 data supports the effectiveness of the treatment Advanced X-Ray Technology for Dental Implants?

Research shows that transcrestal sinus lift procedures, which are part of this treatment, are well established and can provide advantages such as predictable bone augmentation and implant stability. Studies also report successful outcomes with minimal complications and good implant survival rates over several years.12345

Is the Advanced X-Ray Technology for Dental Implants safe for humans?

The procedures related to transcrestal sinus floor elevation, which are similar to the Advanced X-Ray Technology for Dental Implants, have been shown to be safe with no complications reported during or after surgery in studies. Additionally, preventive measures can help avoid complications in high-risk patients.15678

What makes the Closed Sinus Augmentation treatment unique for dental implants?

Closed Sinus Augmentation, also known as transcrestal sinus lift, is unique because it is a less invasive technique compared to the lateral approach, using methods like the sinus balloon technique to elevate the sinus floor and increase bone height. This approach can be performed simultaneously with dental implant placement, reducing the overall treatment time and minimizing complications such as sinus membrane perforation.157910

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.

Research Team

CP

Charles Powell, DDS, MS

Principal Investigator

The University of Texas Health Science Center at San Antonio

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

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

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

Timeline

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)

Treatment Details

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.
Participant Groups
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

Who Is Running the Clinical Trial?

The University of Texas Health Science Center at San Antonio

Lead Sponsor

Trials
486
Recruited
92,500+

Findings from Research

The flapless Localised Management of Sinus Floor (LMSF) technique for maxillary sinus elevation and simultaneous dental implant placement showed a high cumulative success rate of 95% across 71 procedures performed on 52 patients, indicating its efficacy.
This technique is safe with minimal postoperative complications and avoids the need for additional grafting, using only native bone for augmentation, which reduces patient morbidity.
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.Bruschi, GB., Bruschi, E., Papetti, L.[2022]
In a study involving 37 patients, immediate implant insertion combined with transcrestal sinus augmentation showed no implant failures, indicating a high safety and efficacy of this technique for maxillary molar replacement.
The study found that the relationship between maxillary molar roots and the sinus floor can influence bone height, but there were no significant differences in marginal bone loss or other clinical parameters among different root-sinus relationships after one year.
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.Chen, Y., Yuan, S., Zhou, N., et al.[2018]
In a study involving 38 patients and 58 short dental implants, transcrestal sinus elevation using a frontal cutting drill resulted in a high implant survival rate of 96.6% over an average follow-up of 47 months.
The procedure did not negatively impact marginal bone stability, with minimal bone loss observed, indicating that using bone drills alone for sinus elevation is a safe and effective method for placing short implants in patients with limited bone height.
Transcrestal Sinus Floor Augmentation by Sequential Drilling and the Use of Plasma Rich in Growth Factors.Anitua, E., Flores, J., Alkhraisat, MH.[2019]

References

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]
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]
Transcrestal Sinus Floor Augmentation by Sequential Drilling and the Use of Plasma Rich in Growth Factors. [2019]
Radiographic analysis of a transalveolar sinus-lift technique: a multipractice retrospective study with a mean follow-up of 5 years. [2014]
Minimally invasive technique for transcrestal sinus floor elevation: a case report. [2021]
A Successful Treatment Regimen for the Prevention of Sinusitis after Maxillary Sinus Floor Elevation Surgery in a High-Risk Case. [2020]
Transcrestal sinus lift and implant placement using the sinus balloon technique. [2021]
Grafted bone remodeling following transcrestal sinus floor elevation: A cone-beam computed tomography study. [2021]
Different techniques in transalveolar maxillary sinus elevation: A literature review. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
The incidence of maxillary sinus membrane perforation during endoscopically assessed crestal sinus floor elevation: a pilot study. [2022]
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