Two Implants Versus One Implant With a Cantilever - a Randomized Controlled Clinical Trial

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT01649531
First received: July 20, 2012
Last updated: February 4, 2014
Last verified: February 2014
  Purpose

The aim of the present study is to test whether there is a difference in the marginal bone level change between implants with and without cantilevers.


Condition Intervention
Dental Implants
Procedure: 1 Implant
Procedure: 2 Implants

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care

Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • radiographic bone level [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    The primary endpoint of the study is the radiographic bone level 5 years after insertion.The bone level represents an indicator of the osseointegration and biological success of the implant.


Secondary Outcome Measures:
  • Radiographic bone level [ Time Frame: 1 and 3 years ] [ Designated as safety issue: No ]
  • Implant survival and success [ Time Frame: 1, 3, 5 years ] [ Designated as safety issue: No ]
  • rate of technical complication [ Time Frame: 1, 3, 5 years ] [ Designated as safety issue: No ]
    technical complications: screw loosenings, screw fractures, framework fractures, veneering ceramic fractures

  • rate of biological complications [ Time Frame: 1, 3, 5 years ] [ Designated as safety issue: No ]
    biological complications: mucositis, assessed by bleeding on probing

  • Soft tissue changes [ Time Frame: 1, 3, 5 years ] [ Designated as safety issue: No ]
    Soft tissue changes: change in clinical crown length = recession / papilla index

  • Patient morbidity [ Time Frame: 1, 3, 5 years ] [ Designated as safety issue: No ]
    VAS scale to assess pain after implant placement


Estimated Enrollment: 34
Study Start Date: July 2012
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Test group
1 Implant, to be placed in the position with greater vertical bone height with a mesial or distal cantilever.
Procedure: 1 Implant
Active Comparator: Control group
2 Implants
Procedure: 2 Implants

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • male and female patients 18 years to 80 years of age
  • no general medical condition which represents a contraindication to implant treatment
  • two adjacent missing teeth in the maxilla or mandible in positions of premolars and molars
  • at least one tooth present adjacent to the edentulous space
  • indication for implant treatment is given
  • at least 8 mm of vertical bone height in the mandible allowing for the placement of a 6 mm implant (2 mm safety distance to inferior alveolar nerve)
  • at least 4 mm of vertical bone height in the maxilla
  • signed informed consent after being informed

Exclusion Criteria:

  • smoking of more than 15 cigarettes a day (clinical studies show an increased failure rate of implants in heavy smokers)
  • poor oral hygiene after hygienic phase (Plaque Index over 30 %)
  • active periodontal disease
  • pregnancy or breastfeeding at date of inclusion
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01649531

Locations
Switzerland
Center of Dental Medicine Clinic of Fixed and Removable Prosthodontics and Dental Material Science
Zurich, Switzerland, 8032
Sponsors and Collaborators
University of Zurich
Investigators
Principal Investigator: Karin Wolleb, Dr. Center of Dental Medicine Clinic of Fixed and Removable Prosthodontics and Dental Material Science, University of Zurich
  More Information

No publications provided

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01649531     History of Changes
Other Study ID Numbers: 2012-0097
Study First Received: July 20, 2012
Last Updated: February 4, 2014
Health Authority: Switzerland: Ethikkommission

ClinicalTrials.gov processed this record on October 23, 2014