- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06534398
Clinical and Radiographic Outcomes of Implant-supported Prostheses With Cantilever Extensions After 10 Years of Function (Cantilevers)
Clinical and Radiographic Outcomes of Implant-supported Prostheses With Cantilever Extensions. A Retrospective Study With a Follow-up of at Least 10 Years.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Thessaloniki
-
Thessaloníki, Thessaloniki, Greece, 54124
- Aristotle University of Thessaloniki, School of Dentistry
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mean bone loss
Time Frame: 10 years at least
|
Mean bone loss measured from the difference of the bone levels at time of implant placement compared to the time of examination
|
10 years at least
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mean Probing Depth
Time Frame: 10 years at least
|
The average probing depth at the time of examination at each implant site
|
10 years at least
|
|
Biologic complications
Time Frame: 10 years at least
|
Recording of biologic complications around implants (health, peri-implant mucositis, peri-implantitis
|
10 years at least
|
|
Technical complications
Time Frame: 10 years at least
|
Recording of prosthetic complications encountered at the dental prostheses with cantilever extensions
|
10 years at least
|
Collaborators and Investigators
Investigators
- Study Chair: Ioannis Vouros, DDS, PhD, Professor of Periodontology
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Araujo MG, Lindhe J. Peri-implant health. J Periodontol. 2018 Jun;89 Suppl 1:S249-S256. doi: 10.1002/JPER.16-0424.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Pjetursson BE, Zarauz C, Strasding M, Sailer I, Zwahlen M, Zembic A. A systematic review of the influence of the implant-abutment connection on the clinical outcomes of ceramic and metal implant abutments supporting fixed implant reconstructions. Clin Oral Implants Res. 2018 Oct;29 Suppl 18:160-183. doi: 10.1111/clr.13362.
- Renvert S, Persson GR, Pirih FQ, Camargo PM. Peri-implant health, peri-implant mucositis, and peri-implantitis: Case definitions and diagnostic considerations. J Periodontol. 2018 Jun;89 Suppl 1:S304-S312. doi: 10.1002/JPER.17-0588.
- Roccuzzo M, Bonino L, Dalmasso P, Aglietta M. Long-term results of a three arms prospective cohort study on implants in periodontally compromised patients: 10-year data around sandblasted and acid-etched (SLA) surface. Clin Oral Implants Res. 2014 Oct;25(10):1105-12. doi: 10.1111/clr.12227. Epub 2013 Jul 19.
- Romeo E, Tomasi C, Finini I, Casentini P, Lops D. Implant-supported fixed cantilever prosthesis in partially edentulous jaws: a cohort prospective study. Clin Oral Implants Res. 2009 Nov;20(11):1278-85. doi: 10.1111/j.1600-0501.2009.01766.x. Epub 2009 Aug 26.
- Storelli S, Del Fabbro M, Scanferla M, Palandrani G, Romeo E. Implant-supported cantilevered fixed dental rehabilitations in fully edentulous patients: Systematic review of the literature. Part II. Clin Oral Implants Res. 2018 Oct;29 Suppl 18:275-294. doi: 10.1111/clr.13310.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Cantilever implants
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Dental Implants
-
Alexandria UniversityActive, not recruitingDental Implants | Dental Implants, Single-toothEgypt
-
Universiti Sains MalaysiaActive, not recruitingDental Implantation | Dental ImplantsChina
-
Mohammed Bin Rashid University of Medicine and...RecruitingDental ImplantsUnited Arab Emirates
-
Daniele MorettoNot yet recruitingDental Implants
-
Shanghai Ninth People's Hospital Affiliated to...Recruiting
-
Global DRecruitingDental ImplantsFrance, Greece
-
Cairo UniversityActive, not recruiting
-
Aula Dental AvanzadaActive, not recruiting
-
Christopher BarwaczBioHorizons, Inc.Completed
Clinical Trials on Dental implant prosthesis with cantilever extension
-
University of BernCompletedPeri-Implantitis | Dental Implant Failed | Prosthesis FailureSwitzerland
-
Aula Dental AvanzadaCompletedDental Implant Failed | Dental Prosthesis FailureSpain
-
Mansoura UniversityCompletedProsthesis (Internal) ComplicationsEgypt
-
Aula Dental AvanzadaCompleted
-
Aula Dental AvanzadaCompleted
-
Università degli Studi di SassariDr. Dario Melodia; Dr. Milena Pisano; Dr. Aurea Lumbau; Prof. Silvio Mario Meloni; Prof. Edoardo BaldoniNot yet recruiting
-
Menoufia UniversityTanta UniversityRecruitingBone Loss | Partial Edentulism Class 1Egypt
-
Universitaire Ziekenhuizen KU LeuvenDentsply Sirona Implants and ConsumablesCompleted
-
Mansoura UniversityActive, not recruitingDental Implant Bone Loss | Peri-Implant HealthEgypt
-
KLE Society's Institute of Dental SciencesUnknown