Advanced X-Ray Technology for Dental Implants

Overseen By Charles Powell, DDS, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas Health Science Center at San Antonio

Must not be taking: Bone metabolism drugs

Disqualifiers: Maxillary sinus disease, Diabetes, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

25 Participants Needed

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. ^{1 2 3 4 5}

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. ^{1 3 4 5 6}

Who Is on the Research Team?

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.

Exclusion Criteria

I am taking medication that affects bone health.

Alcoholism or other recreational drugs

My condition affects how my bones use nutrients.

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?

Group I: Closed sinus augmentation with Calcium Phosphosilicate Putty Experimental Treatment 1 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

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

In a study of 25 implant sites, the use of synthetic biphasic calcium phosphate for transcrestal sinus floor elevation resulted in an average graft height reduction of 0.57 mm after 6-8 months, indicating some degree of remodeling of the grafted bone.

The reduction in graft height was positively correlated with factors such as the vertical amount of implant protrusion and the vertical elevation height, suggesting that these factors may influence the stability of the grafted bone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Grafted bone remodeling following transcrestal sinus floor elevation: A cone-beam computed tomography study. Kuo, PY., Lin, CY., Chang, CC., et al.[2021]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Transalveolar sinus elevation is a less invasive and time-efficient technique for addressing bone height deficiencies in the posterior maxilla, making it a favorable option for dental implant placement.

The review analyzed 26 articles on various modifications of this technique, highlighting that the choice of method should depend on the clinician's expertise, available equipment, and the specific bone conditions of the patient.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Different techniques in transalveolar maxillary sinus elevation: A literature review. Lafzi, A., Atarbashi-Moghadam, F., Amid, R., et al.[2022]

The transcrestal sinus lift using the sinus balloon technique resulted in an average bone height gain of 8.7 mm, allowing for successful dental implant placement even with only 3 mm of residual bone.

One year after the procedure, the implant success rate was 100% in the five patients studied, indicating the efficacy and safety of this minimally invasive technique.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcrestal sinus lift and implant placement using the sinus balloon technique. Peñarrocha-Diago, M., Galán-Gil, S., Carrillo-García, C., et al.[2021]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcrestal Sinus Floor Augmentation by Sequential Drilling and the Use of Plasma Rich in Growth Factors. Anitua, E., Flores, J., Alkhraisat, MH.[2019]

The transalveolar sinus-lift technique demonstrated a high implant success rate of 94.9% over a mean follow-up of 5 years, indicating its efficacy in dental implant procedures.

Using inorganic bovine bone matrix resulted in a better implant success rate compared to demineralized human matrix, and the technique was associated with low marginal bone loss of 1.98 mm, highlighting its safety and effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiographic analysis of a transalveolar sinus-lift technique: a multipractice retrospective study with a mean follow-up of 5 years. Soardi, E., Cosci, F., Checchi, V., et al.[2014]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11560410/

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.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06507709?cond=dental&locStr=United+States&country=United+States&aggFilters=status:

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.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1010518214002479

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 ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12063990/

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

5. openaccesspub.org openaccesspub.org/dentistry-and-oral-implants/article/344

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.

6. researchgate.net researchgate.net/publication/341693184_Minimally_Invasive_Transalveolar_Sinus_Augmentation_An_Answer_to_Sinus_Conundrum

(PDF) Minimally Invasive Transalveolar Sinus Augmentation This method utilizes the calcium phosphosilicate putty for hydraulic sinus membrane elevation along with osseodensification drills.