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Dental ImplantsCantileversNCT06534398

Clinical and Radiographic Outcomes of Implant-supported Prostheses With Cantilever Extensions After 10 Years of Function

An observational study of Dental Implants, run by Aristotle University Of Thessaloniki at 1 site in Greece.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

A retrospective examination was performed on patients who had received treatment with dental implants supporting a prosthesis with a cantilever extension for at least 10 years of function. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Dental Implants
What is being tested?
Dental implant prosthesis with cantilever extension
Type of treatment
Medical device
How many people
19 participants
Where
1 siteGreece
Study dates
1 May 2024to 30 Jul 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Study population: The patient sample of this study is part of a retrospective evaluation of patients who received treatment with dental implants in a private periodontal practice environment between 2000 and 2013, with at least 10 years of functional loading of their prosthetic work. Patients who received Fixed Dental Prostheses with Cantilever Extension were included in this study sample

The inclusion criteria were as follows:

  • Age 18 years and over
  • Systemic health or controlled medical conditions
  • Periodontal health, either no periodontal disease, or previously treated periodontal disease and under a supportive periodontal maintenance (SPT) program
  • Smokers were included but encouraged to enter a smoking cessation program
  • Patients with bruxism or parafunctional habits were included.

The exclusion criteria were as follows:

  • Uncontrolled medical conditions
  • Active uncontrolled periodontal disease
  • Inability to present for the reevaluation appointment
  • Immediate implant placement
  • Cantilever units that were part of full-arch restorations
  • Cantilever units that were connected to a single implant
  • Non-existent opposing dentition

Trial locations and contacts

1 site in 1 country.

Greece1 site

  • Aristotle University of Thessaloniki, School of Dentistry

    Thessaloniki, Thessaloniki, 54124

Other trials in Greece

About this study

Official title: Clinical and Radiographic Outcomes of Implant-supported Prostheses With Cantilever Extensions. A Retrospective Study With a Follow-up of at Least 10 Years.

A retrospective examination was performed on patients who had received treatment with dental implants supporting a prosthesis with a cantilever extension for at least 10 years of function.

Read the detailed description

The successful use of osseointegrated dental implants in replacing missing teeth has been adequately documented, with multiple studies reporting long-term success exceeding 10 years of function. However, there is still insufficient evidence in cases where availability of adequate bone precludes ideal placement of implants. Examples of cases like these include the posterior maxilla when pneumatization of the maxillary sinus does not allow for placement of implants, or areas of thin bone that would require extensive guided bone regeneration (GBR) techniques and increase patient morbidity. In such cases the use of fixed dental prostheses (FDPC's) with cantilever extension has been suggested in lieu of sinus lift techniques or GBR procedures. However, few studies have actually addressed the long-term success of such FDPC's, both from a surgical and a prosthetic standpoint, especially in posterior areas of the mandible and maxilla where loading forces are expected to be higher.

Two studies addressed this issue in the early 2000's with successful outcomes reported for an observation period of 5 years. Others reported similar outcomes after a mean observation period of 5.6 years. The 5th Consensus Conference of the European Association of Osseointegration (EAO) suggested that such treatment can be recommended to patients, albeit with little available evidence and limited follow-up of cases. Recent studies have delved further into this issue, offering longer follow-up data of more than 10 years of function. They included both 2 unit FDP's anchored on one implant and 3 unit FDP's anchored on two implants with cantilever extensions. They concluded that this treatment modality is a reliable option with long-term stability and few complications, mainly prosthetic.

The aim of this retrospective study is to offer further data on the long-term success and complications when at least two dental implants are used to support a FDPC in the posterior areas of both jaws, after at least 10 years of function.

Conditions
Dental Implants
Being tested
Dental implant prosthesis with cantilever extension
Keywords
Dental implants, cantilever extension, biologic complications, technical complications

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dental implant prosthesis with cantilever extensionDevice

    A retrospective study on the radiographic and clinical findings of implant-supported dental prostheses with cantilever extensions in place and function for at least 10 years

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean bone loss

    Mean bone loss measured from the difference of the bone levels at time of implant placement compared to the time of examination

    Measured: 10 years at least

Secondary outcomes (3)

  1. Mean Probing Depth

    The average probing depth at the time of examination at each implant site

    Measured: 10 years at least

  2. Biologic complications

    Recording of biologic complications around implants (health, peri-implant mucositis, peri-implantitis

    Measured: 10 years at least

  3. Technical complications

    Recording of prosthetic complications encountered at the dental prostheses with cantilever extensions

    Measured: 10 years at least

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Aug 2024
  2. Study start1 May 2024
  3. Primary completion30 Jul 2024
  4. Study completion30 Jul 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
19 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06534398
Sponsor's protocol ID
Cantilever implants
Acronym
Cantilevers
Status last verified
Aug 2024
First submitted
30 Jul 2024
Last updated
7 Aug 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Undecided

Publications

  • Wennstrom J, Zurdo J, Karlsson S, Ekestubbe A, Grondahl K, Lindhe J. Bone level change at implant-supported fixed partial dentures with and without cantilever extension after 5 years in function. J Clin Periodontol. 2004 Dec;31(12):1077-83. doi: 10.1111/j.1600-051X.2004.00603.x.

    PubMed 15560808

  • Schmid E, Morandini M, Roccuzzo A, Ramseier CA, Sculean A, Salvi GE. Clinical and radiographic outcomes of implant-supported fixed dental prostheses with cantilever extension. A retrospective cohort study with a follow-up of at least 10 years. Clin Oral Implants Res. 2020 Dec;31(12):1243-1252. doi: 10.1111/clr.13672. Epub 2020 Oct 17.

    PubMed 32991763

  • Aglietta M, Iorio Siciliano V, Blasi A, Sculean A, Bragger U, Lang NP, Salvi GE. Clinical and radiographic changes at implants supporting single-unit crowns (SCs) and fixed dental prostheses (FDPs) with one cantilever extension. A retrospective study. Clin Oral Implants Res. 2012 May;23(5):550-5. doi: 10.1111/j.1600-0501.2011.02391.x. Epub 2012 Jan 17.

    PubMed 22250868

  • Araujo MG, Lindhe J. Peri-implant health. J Periodontol. 2018 Jun;89 Suppl 1:S249-S256. doi: 10.1002/JPER.16-0424.

    PubMed 29926949

  • Baumer A, Toekan S, Saure D, Korner G. Survival and success of implants in a private periodontal practice: a 10 year retrospective study. BMC Oral Health. 2020 Mar 30;20(1):92. doi: 10.1186/s12903-020-01064-z.

    PubMed 32228667

  • Berglundh T, Armitage G, Araujo MG, Avila-Ortiz G, Blanco J, Camargo PM, Chen S, Cochran D, Derks J, Figuero E, Hammerle CHF, Heitz-Mayfield LJA, Huynh-Ba G, Iacono V, Koo KT, Lambert F, McCauley L, Quirynen M, Renvert S, Salvi GE, Schwarz F, Tarnow D, Tomasi C, Wang HL, Zitzmann N. Peri-implant diseases and conditions: Consensus report of workgroup 4 of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions. J Clin Periodontol. 2018 Jun;45 Suppl 20:S286-S291. doi: 10.1111/jcpe.12957.

    PubMed 29926491

  • Chappuis V, Buser R, Bragger U, Bornstein MM, Salvi GE, Buser D. Long-term outcomes of dental implants with a titanium plasma-sprayed surface: a 20-year prospective case series study in partially edentulous patients. Clin Implant Dent Relat Res. 2013 Dec;15(6):780-90. doi: 10.1111/cid.12056. Epub 2013 Mar 18.

    PubMed 23506385

  • Derks J, Schaller D, Hakansson J, Wennstrom JL, Tomasi C, Berglundh T. Effectiveness of Implant Therapy Analyzed in a Swedish Population: Prevalence of Peri-implantitis. J Dent Res. 2016 Jan;95(1):43-9. doi: 10.1177/0022034515608832.

    PubMed 26701919

  • Frisch E, Wild V, Ratka-Kruger P, Vach K, Sennhenn-Kirchner S. Long-term results of implants and implant-supported prostheses under systematic supportive implant therapy: A retrospective 25-year study. Clin Implant Dent Relat Res. 2020 Dec;22(6):689-696. doi: 10.1111/cid.12944. Epub 2020 Sep 23.

    PubMed 32969180

  • Gracis S, Michalakis K, Vigolo P, Vult von Steyern P, Zwahlen M, Sailer I. Internal vs. external connections for abutments/reconstructions: a systematic review. Clin Oral Implants Res. 2012 Oct;23 Suppl 6:202-16. doi: 10.1111/j.1600-0501.2012.02556.x.

    PubMed 23062143

  • Halg GA, Schmid J, Hammerle CH. Bone level changes at implants supporting crowns or fixed partial dentures with or without cantilevers. Clin Oral Implants Res. 2008 Oct;19(10):983-90. doi: 10.1111/j.1600-0501.2008.01556.x.

    PubMed 18828813

  • Hammerle CHF, Cordaro L, Alccayhuaman KAA, Botticelli D, Esposito M, Colomina LE, Gil A, Gulje FL, Ioannidis A, Meijer H, Papageorgiou S, Raghoebar G, Romeo E, Renouard F, Storelli S, Torsello F, Wachtel H. Biomechanical aspects: Summary and consensus statements of group 4. The 5th EAO Consensus Conference 2018. Clin Oral Implants Res. 2018 Oct;29 Suppl 18:326-331. doi: 10.1111/clr.13284.

    PubMed 30306690

  • Karoussis IK, Salvi GE, Heitz-Mayfield LJ, Bragger U, Hammerle CH, Lang NP. Long-term implant prognosis in patients with and without a history of chronic periodontitis: a 10-year prospective cohort study of the ITI Dental Implant System. Clin Oral Implants Res. 2003 Jun;14(3):329-39. doi: 10.1034/j.1600-0501.000.00934.x.

    PubMed 12755783

  • Lekholm U, Grondahl K, Jemt T. Outcome of oral implant treatment in partially edentulous jaws followed 20 years in clinical function. Clin Implant Dent Relat Res. 2006;8(4):178-86. doi: 10.1111/j.1708-8208.2006.00019.x.

    PubMed 17100743

  • Mombelli A, van Oosten MA, Schurch E Jr, Land NP. The microbiota associated with successful or failing osseointegrated titanium implants. Oral Microbiol Immunol. 1987 Dec;2(4):145-51. doi: 10.1111/j.1399-302x.1987.tb00298.x. No abstract available.

    PubMed 3507627

Questions about this trial

What is this clinical trial studying?

An observational study of Dental Implants, run by Aristotle University Of Thessaloniki at 1 site in Greece.

The full registered description is in the About this study section and the official record.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean bone loss (time frame: 10 years at least). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06534398, which also lists 20 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2024; AzTrials last refreshed its copy on 8 Nov 2026.

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