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

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ClinicalTrials.gov Identifier: NCT01649531
Recruitment Status : Active, not recruiting
First Posted : July 25, 2012
Last Update Posted : February 23, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Dental Implants Procedure: 1 Implant Procedure: 2 Implants

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Study Start Date : July 2012
Estimated Primary Completion Date : December 2018
Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. radiographic bone level [ Time Frame: 5 years ]
    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 :
  1. Radiographic bone level [ Time Frame: 1 and 3 years ]
  2. Implant survival and success [ Time Frame: 1, 3, 5 years ]
  3. rate of technical complication [ Time Frame: 1, 3, 5 years ]
    technical complications: screw loosenings, screw fractures, framework fractures, veneering ceramic fractures

  4. rate of biological complications [ Time Frame: 1, 3, 5 years ]
    biological complications: mucositis, assessed by bleeding on probing

  5. Soft tissue changes [ Time Frame: 1, 3, 5 years ]
    Soft tissue changes: change in clinical crown length = recession / papilla index

  6. Patient morbidity [ Time Frame: 1, 3, 5 years ]
    VAS scale to assess pain after implant placement


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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: Daniel Thoma, PD Dr. Center of Dental Medicine Clinic of Fixed and Removable Prosthodontics and Dental Material Science, University of Zurich
More Information

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01649531     History of Changes
Other Study ID Numbers: 2012-0097
First Posted: July 25, 2012    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: February 2017