NCT06534398

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 30, 2024

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 2, 2024

Completed
Last Updated

August 7, 2024

Status Verified

August 1, 2024

Enrollment Period

3 months

First QC Date

July 30, 2024

Last Update Submit

August 6, 2024

Conditions

Keywords

Dental implantscantilever extensionbiologic complicationstechnical complications

Outcome Measures

Primary Outcomes (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

    10 years at least

Secondary Outcomes (3)

  • Mean Probing Depth

    10 years at least

  • Biologic complications

    10 years at least

  • Technical complications

    10 years at least

Interventions

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

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aristotle University of Thessaloniki, School of Dentistry

Thessaloniki, Thessaloniki, 54124, Greece

Location

Related Publications (20)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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 Officials

  • Ioannis Vouros, DDS, PhD

    Professor of Periodontology

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 30, 2024

First Posted

August 2, 2024

Study Start

May 1, 2024

Primary Completion

July 30, 2024

Study Completion

July 30, 2024

Last Updated

August 7, 2024

Record last verified: 2024-08

Locations