Radiographic Techniques 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, Pregnancy, Diabetes, others

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

Compensation: Varies

Number of Visits: 3

Duration: Immediate postoperative period

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores ways to improve dental implant procedures by testing different radiographic techniques. It focuses on patients needing a sinus lift (a procedure to add bone below the sinus) for dental implants. The trial compares two methods: a specialized 3D X-ray (low volume CBCT) and standard dental X-rays. Ideal participants are nonsmokers who have lost some teeth and need a sinus lift but have at least 5mm of bone below the sinus. Participants should not have sinus disease or conditions affecting bone health.

As an unphased trial, this study allows patients to contribute to advancements in dental care techniques.

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 that affect bone metabolism.

What prior data suggests that these radiographic techniques are safe for dental implant planning?

Research shows that the closed sinus augmentation technique is generally safe for placing dental implants. Studies have found that this method has high success rates, with implants remaining securely in place after surgery. Previous patients demonstrated that this approach is reliable and safe. No major reports of serious side effects have emerged from using this technique. Some research suggests positive results, with a good success rate in creating enough bone for implants. In summary, closed sinus augmentation is well-tolerated and successful in dental implant procedures. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores different radiographic techniques for planning dental implant placements. Unlike traditional methods that rely on standard periapical radiographs, this trial investigates low volume cone beam computed tomography (CBCT). CBCT offers a more detailed 3D view, potentially leading to more precise implant placement and better overall outcomes. By comparing these techniques, the trial aims to find out which method provides the best results, potentially setting a new standard in dental implant planning.

What evidence suggests that these radiographic techniques are effective for dental implant placement?

This trial will compare different radiographic techniques for planning dental implant placement. Studies have shown that closed sinus augmentation for dental implants is highly effective. A review of several studies found a 100% survival rate for implants, regardless of bone graft use. Another study demonstrated a 99.5% success rate six months after fitting the implants with crowns. Additionally, research indicated that over 92.7% of implants lasted at least five years, even with varying bone heights. Overall, closed sinus augmentation is a reliable method for placing dental implants with excellent long-term results. ^{1 2 6 7 8}

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 who require a closed sinus augmentation procedure to prepare for dental implant placement. Specific eligibility criteria are not provided, so it's best to contact the study organizers for detailed requirements.

Inclusion Criteria

Nonsmokers

I need a procedure to prepare for dental implants due to missing some teeth.

I have at least 5mm of bone under my sinus.

Exclusion Criteria

Tobacco use

Alcoholism or recreational drug use

My diabetes is not well-controlled (HbA1C above 7.0).

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Closed sinus augmentation is performed for dental implant placement

Immediate postoperative period

1 visit (in-person)

Follow-up

Participants are monitored for dimensional changes in augmentation using CBCT and standard radiographs

6 months

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Closed Sinus Augmentation

Trial Overview The study is examining changes in the maxillary sinus after a closed sinus lift by comparing images from a 3D R100 scanner with those from conventional radiographs.

How Is the Trial Designed?

Group I: Low volume CBCT Active Control 1 Intervention

Radiographic low volume cone beam computed tomography used to plan implant placement

Group II: Standard periapical radiographs Placebo Group 1 Intervention

Standard radiography used to plan implant placement

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

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]

The chapter emphasizes the importance of implant stability, which is heavily influenced by the amount of available bone, particularly in the posterior maxilla where low-lying maxillary sinuses can limit alveolar height.

It reviews traditional methods like the lateral sinus lift and the transcrestal osteotome approach for vertical bone augmentation, along with osseodensification as a potential alternative technique.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Update on Maxillary Sinus Augmentation. Bhalla, N., Dym, H.[2021]

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]

The study found that maxillary sinus floor elevation with a transcrestal approach (tSFE) during implant placement resulted in low postoperative pain and complications, similar to implants placed entirely in native bone, based on data from 31 patients.

Both procedures showed comparable patient-reported outcomes, with no significant differences in pain levels, discomfort, or willingness to undergo the surgery again, indicating that tSFE does not increase the morbidity of implant surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-reported outcomes of implant placement performed concomitantly with transcrestal sinus floor elevation or entirely in native bone. Franceschetti, G., Rizzi, A., Minenna, L., et al.[2018]

The sinus lift procedure, while generally safe, can lead to complications such as perforation of the sinus membrane, which requires effective repair techniques.

Using a pedicled buccal fat pad for closing large perforations during the sinus lift showed promising results, with no serious infections and satisfactory clinical and radiographic outcomes after one year.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Closure of large perforation of sinus membrane using pedicled buccal fat pad graft: a case report. Kim, YK., Hwang, JW., Yun, PY.[2022]

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]

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]

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]

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]

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]

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 new internal crestal approach for sinus lift procedures, which uses hydraulic pressure and a specialized bone grafting technique, minimizes the risk of membrane perforation and allows for simultaneous implant placement.

In a retrospective study of 1,100 cases, the method demonstrated a low failure rate of 0.73% for implants and showed effectiveness in patients with limited alveolar ridge heights, making it a reliable option for challenging anatomical conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An 8-year retrospective study: 1,100 patients receiving 1,557 implants using the minimally invasive hydraulic sinus condensing technique. Chen, L., Cha, J.[2014]

Citations

1. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0266435624001177

Clinical outcomes of implants placed with transcrestal ... The meta-analysis showed a 100% (95% CI: 99% to 100%) survival rate for both grafted and non-grafted transcrestal sinus lifts using hand osteotomes. Meta- ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9970713/

15-Year Retrospective Study on the Success Rate of ... Six months after the installation of the prosthetic crowns, the success rate of the inserted implants was 99.5%, suggesting that maxillary sinus ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4588341/

Transcrestal Sinus Lift Procedure Approaching Atrophic ... This technique documented a 5-year survival rate superior to 92.7% for implants placed in less than 5 mm ridge height and 94.9% for implants inserted in more ...

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/prd.70009

Long‐term stability of transcrestal sinus augmentation Transcrestal sinus augmentation has emerged as a minimally invasive alternative to lateral window techniques for vertical bone augmentation ...

5. mdpi.com mdpi.com/2076-3417/13/11/6668

Effect of Different Crestal Sinus Lift Techniques for Implant ... This study evaluated dental implant stability, vertical bone gain, bone density, and crestal bone loss using different crestal sinus lift techniques.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10753870/

Maxillary Sinus Lift Procedures: An Overview of Current ... The primary goal of this intervention is to create enough bone height and width to facilitate the proper placement of dental implants. This goal ...

7. nature.com nature.com/articles/s41368-023-00248-x

Maxillary sinus floor augmentation: a review of current ... Maxillary sinus floor augmentation (MSFA) involves Schneiderian membrane elevation to increase the residual crestal bone height (RBH) in the posterior maxilla.

8. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1111/cid.13389

Clinical and radiographic changes following transcrestal ... Transcrestal sinus floor augmentation (tSFA) is a predictable and safe surgical approach to rehabilitate posterior edentulous areas where there is inadequate ...