Sinus Augmentation for Dental Implants

Overseen By Lorenzo Mordini, DDS, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Tufts University

Disqualifiers: Osteoporosis, Chemotherapy, Heavy smoking, 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: Unknown

Duration: Immediate

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how well bone heals after a sinus lift procedure, used to prepare for dental implants. Researchers compare two methods: a mix of a patient's own bone with a material called xenograft, and using only xenograft. It suits patients at Tufts School of Dental Medicine who have lost their upper teeth and need more bone for dental implants. Participants should have less than 5mm of bone in the sinus area before the procedure. As an unphased trial, this study allows participants to contribute to valuable research that could enhance future dental procedures.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that sinus lift augmentation, a procedure that adds bone to the upper jaw, is generally safe and well-tolerated. Studies have found that using a mix of animal bone and a patient's own bone in a 4:1 ratio is a reliable method. This approach aids in placing dental implants and has proven successful over the years.

Another study found that using either animal bone or a patient's own bone in this procedure results in high dental implant survival rates, meaning the implants remain in place and function well. These findings suggest that the treatments tested in this trial are likely safe and effective for most people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about sinus lift augmentation techniques for dental implants due to their innovative approach to using graft materials. Unlike standard treatments that might rely solely on synthetic or natural bone substitutes, one investigational method combines xenografts, which are derived from animal sources, with a patient's own bone in a 1:4 ratio. This combination could enhance bone integration and stability more effectively than using xenografts alone. Additionally, exploring the use of xenografts by themselves as a comparator offers valuable insights into how different grafting techniques might improve dental implant success rates. This trial aims to uncover which method provides the best results for patients needing dental implants, potentially leading to better outcomes and faster recovery times.

What evidence suggests that this trial's treatments could be effective for sinus augmentation?

Research has shown that adding bone to the upper jaw, known as sinus lift augmentation, effectively supports dental implants. In this trial, one group will receive a sinus graft with a mix of the patient's own bone and bone from another species. Studies have found this approach leads to a high success rate of about 92% for implants. Another group will receive a sinus graft using only bone from another species. Previous studies confirm that both types of bone materials are effective in sinus lifts, resulting in high implant survival rates. These findings suggest that combining these bone types can effectively promote bone healing and support dental implants. ^{1 4 5 6 7}

Who Is on the Research Team?

Lorenzo Mordini, DDS, MS

Principal Investigator

Tufts Univeristy

Are You a Good Fit for This Trial?

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

I need a sinus lift for dental implants due to having less than 5mm of bone height.

Exclusion Criteria

Patients who self-report as pregnant or breastfeeding

Wards of the state

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Sinus Lift augmentation

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.

How Is the Trial Designed?

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 United States, European Union, Canada for the following indications:

Approved in United States as Sinus Augmentation for:

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

Approved in European Union as Sinus Lift for:

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

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+

Published Research Related to This Trial

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 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]

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 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]

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]

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 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]

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]

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]

Citations

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pmc.ncbi.nlm.nih.gov

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15-Year Retrospective Study on the Success Rate of ...

One systematic review of maxillary sinus lift and implant success rates with follow-up ranging from 12 to 102 months showed a success rate of 92 ...

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The aim of this systematic review was to determine whether autogenous tooth grafting material (ATGM) is as safe and effective as other bone substitutes used ...

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This review seeks to compare the effectiveness, complications, and long-term outcomes of autogenous, allograft, and xenograft materials in sinus lifting ...

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After 6 months, a total of 39 dental implants were placed in the posterior maxilla, with both graft materials showing high implant survival ...

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The purpose of this article is to assess the change of bone volume and the clinical effects of dental implant placement in sites with maxillary sinus floor ...

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8085675/

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Maxillary sinus floor augmentation (MSFA) applying the lateral window technique is a safe and predictable surgical procedure to increase the alveolar bone ...

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clinicaltrials.gov

clinicaltrials.gov/study/NCT07014085

Prospective Study of Bone Augmentation With Lateral ...

Objective: This study aims to compare and analyse the effectiveness of xenograft and autologous bone grafts in bone augmentation procedures for patients ...