Sinus Augmentation for Dental Implants

Overseen By Lorenzo Mordini, DDS, MS

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Tufts University

Disqualifiers: Osteoporosis, Chemotherapy, Heavy smoking, others

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

To evaluate bone healing at 4 months after lateral sinus augmentation with a 4:1 ratio of autologous bone and xenograft or xenograft alone. A radiographic volumetric, histomorphometric, and histologic analysis.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Sinus Lift augmentation for dental implants?

Research shows that sinus lift techniques, including crestal and lateral approaches, can effectively raise the sinus floor and support dental implants. Studies indicate that these methods, especially when combined with bone grafting, lead to stable implant placement and minimal complications over time. ^{1 2 3 4 5}

Is sinus augmentation for dental implants safe?

Sinus augmentation, also known as sinus lift, is generally considered safe, but it can have complications like membrane perforation, infection, and bleeding. These issues are usually rare and can often be managed effectively. ^{4 6 7 8 9}

How is the Sinus Lift augmentation treatment different from other treatments for dental implants?

Sinus Lift augmentation is unique because it involves elevating the sinus membrane to create space for bone grafts and dental implants, often using a lateral or crestal approach. Unlike some other methods, it can be performed with or without graft materials, and it focuses on enhancing bone height in the upper jaw where bone is insufficient for implants. ^{2 3 9 10 11}

Research Team

Lorenzo Mordini, DDS, MS

Principal Investigator

Tufts Univeristy

Eligibility Criteria

This trial is for adults aged 18-100 who are patients at Tufts School of Dental Medicine, needing bone grafts for dental implants due to significant tooth loss. They must have a specific amount of residual bone height and not be pregnant, breastfeeding, or heavy smokers. Those with osteoporosis, prior sinus procedures, existing sinus issues, or conditions affecting bone metabolism can't join.

Inclusion Criteria

Patients of Tufts School of Dental Medicine (TUSDM)

I am between 18 and 100 years old.

I have no upper teeth or missing teeth except for the front ones.

Exclusion Criteria

I am unable to make medical decisions due to cognitive impairment.

Patients who self-report as pregnant or breastfeeding

Wards of the state

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo lateral sinus augmentation with either a 4:1 ratio of autologous bone and xenograft or xenograft alone

Immediate

Follow-up

Participants are monitored for bone healing through radiographic volumetric, histomorphometric, and histologic analysis

4 months

Treatment Details

Interventions

• Sinus Lift augmentation (Bone Graft)

Trial Overview The study tests the effectiveness of two types of bone healing after a sinus lift augmentation: one using a mix of the patient's own bone (autograft) with xenograft material versus using only xenograft material. The outcomes will be measured through radiographic analysis and tissue samples at four months post-procedure.

Participant Groups

Group I: Xenograft - Autogenous 1:4 Experimental Treatment 2 Interventions

Sinus grafted with a ratio of Xenograft - Autogenous 1:4

Group II: Xenograft alone Active Control 2 Interventions

Sinus grafted with Xenograft only

Sinus Lift augmentation is already approved in Canada for the following indications:

Approved in Canada as Sinus Graft for:

• Insufficient bone in the posterior maxilla for dental implant placement
• Bone loss due to tooth extraction or periodontal disease

Who Is Running the Clinical Trial?

Tufts University

Lead Sponsor

Trials

271

Recruited

595,000+

Findings from Research

Nongrafted maxillary sinus floor elevation can achieve new bone formation and a high implant survival rate that is comparable to traditional bone-graft-assisted methods, based on a systematic review of six studies.

The review found no significant long-term differences in implant survival, endosinus bone gain, crestal bone loss, or bone density between nongrafted and graft-assisted techniques, indicating that both methods may be effective for dental implants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dental implants combined with sinus augmentation: What is the merit of bone grafting? A systematic review. Nasr, S., Slot, DE., Bahaa, S., et al.[2022]

The new crestal sinus lift technique was successfully performed on 11 patients, allowing for a mean sinus floor elevation of 4.8 mm without any complications or membrane perforations during the procedure.

All 12 implants placed simultaneously with the sinus lift healed well over an average follow-up period of 49.4 months, indicating the technique's efficacy and safety in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Minimally Invasive Crestal Sinus Lift Technique and Simultaneous Implant Placement. Zhou, X., Hu, XL., Li, JH., et al.[2021]

Implant survival rates after maxillary sinus membrane elevation without graft material were very high, ranging from 96% to 100%, similar to the 100% survival seen with grafts like autogenous bone.

New bone formation was enhanced without graft material, showing significant increases in bone density, particularly when using blood clots, although long-term comparative studies are still needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Maxillary Sinus Membrane Elevation With Simultaneous Installation of Implants Without the Use of a Graft Material: A Systematic Review. Starch-Jensen, T., Schou, S.[2022]

Maxillary sinus floor elevation using the lateral approach is a reliable procedure for bone augmentation in implant dentistry, but it carries risks of both intra- and postoperative complications, some of which can be severe.

The review aims to identify risk factors for these complications and provide clinical recommendations to enhance patient safety and improve overall care standards.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How to avoid intraoperative and postoperative complications in maxillary sinus elevation. Testori, T., Tavelli, L., Scaini, R., et al.[2023]

The crestal sinus lift technique, used in conjunction with bone grafting and implant placement, successfully elevated the sinus floor by an average of 5 mm without complications, indicating its safety and efficacy as an alternative to traditional methods.

With a mean follow-up of 50 months, the implants showed stable peri-implant marginal bone and no postoperative complications, suggesting that this technique can be a reliable option for sinus augmentation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mini Crestal Sinus Lift With Bone Grafting and Simultaneous Insertion of Implants in Severe Maxillary Conditions as an Alternative to Lateral Sinus Lift: Multicase Study Report of Different Techniques. Rosa, A., Ranieri, N., Miranda, M., et al.[2023]

The sinus augmentation procedure is designed to increase bone height in the upper jaw to facilitate dental implant placement, and it has a low overall complication rate.

Common complications include perforation of the Schneiderian membrane, bleeding, infection, and rhinosinusitis, which are important considerations for dental professionals performing this procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current concepts on complications associated with sinus augmentation procedures. Boffano, P., Forouzanfar, T.[2018]

In a study involving 68 patients and 101 sinus augmentations, the lateral window approach for dental implants showed a high overall success rate of 90% after 12 to 120 months, indicating its efficacy.

However, complications such as membrane perforations and infections occurred, and the simultaneous placement of implants during sinus augmentation was associated with a higher risk of implant failure compared to staged placement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lateral window sinus augmentation: complications and outcomes of 101 consecutive procedures. Guerrero, JS.[2017]

A new technique was developed to repair large perforations (10 mm) in the sinus membrane that can occur during maxillary sinus floor elevation, which is important for dental implant placement.

The technique involves suturing the sinus membrane with a resorbable material to the bone, allowing for successful completion of the sinus augmentation procedure and enabling graft insertion, thus addressing a common complication effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel technique to close large perforation of sinus membrane. Clementini, M., Ottria, L., Pandolfi, C., et al.[2022]

Graftless maxillary sinus lift techniques for dental implants show a promising 90% success rate in cases followed for at least six months to four years, indicating their efficacy.

The review highlights various methods used in graftless procedures, such as lateral window techniques and membrane elevation, suggesting that these approaches can effectively promote bone repair and support dental implant placement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical and biological analysis in graftless maxillary sinus lift. Parra, M., Olate, S., Cantín, M.[2020]

The study demonstrated that a nongrafted sinus lift procedure using a bioresorbable HA/PLLA mesh plate resulted in continuous bone gain around dental implants over a 3-year follow-up period, indicating its efficacy in bone regeneration.

The use of the HA/PLLA mesh device not only maintained the space under the elevated sinus membrane but also promoted stable and predictable bone formation, suggesting a promising approach for patients with atrophic maxillae.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous intra-sinus bone regeneration after nongrafted sinus lift with a PLLA mesh plate device and dental implant placement in an atrophic posterior maxilla: a case report. Kaneko, T., Nakamura, S., Hino, S., et al.[2020]

The palatal approach for open sinus lift is beneficial for patients with challenging anatomical conditions, such as thick buccal bone or previous insufficient sinus lifts, as demonstrated in a retrospective study of 10 patients.

This technique serves as a useful alternative for maxillary sinus augmentation, particularly in cases where traditional lateral approaches may be difficult or ineffective.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Indications for palatal sinus lift: Case series. Rahpeyma, A., Khajehahmadi, S.[2022]

References

1. Scotland pubmed.ncbi.nlm.nih.gov

Dental implants combined with sinus augmentation: What is the merit of bone grafting? A systematic review. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Minimally Invasive Crestal Sinus Lift Technique and Simultaneous Implant Placement. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Maxillary Sinus Membrane Elevation With Simultaneous Installation of Implants Without the Use of a Graft Material: A Systematic Review. [2022]

4. Denmark pubmed.ncbi.nlm.nih.gov

How to avoid intraoperative and postoperative complications in maxillary sinus elevation. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Mini Crestal Sinus Lift With Bone Grafting and Simultaneous Insertion of Implants in Severe Maxillary Conditions as an Alternative to Lateral Sinus Lift: Multicase Study Report of Different Techniques. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Current concepts on complications associated with sinus augmentation procedures. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Lateral window sinus augmentation: complications and outcomes of 101 consecutive procedures. [2017]

8. Italy pubmed.ncbi.nlm.nih.gov

A novel technique to close large perforation of sinus membrane. [2022]

9. Korea (South) pubmed.ncbi.nlm.nih.gov

Clinical and biological analysis in graftless maxillary sinus lift. [2020]

10. Germany pubmed.ncbi.nlm.nih.gov

Continuous intra-sinus bone regeneration after nongrafted sinus lift with a PLLA mesh plate device and dental implant placement in an atrophic posterior maxilla: a case report. [2020]

11. India pubmed.ncbi.nlm.nih.gov

Indications for palatal sinus lift: Case series. [2022]