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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01649531
Recruitment Status : Active, not recruiting
First Posted : July 25, 2012
Last Update Posted : November 14, 2019
Information provided by (Responsible Party):
University of Zurich

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 Phase
Dental Implants Procedure: 1 Implant Procedure: 2 Implants Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Two Implants Versus One Implant With a Cantilever - a Randomized Controlled Clinical Trial
Actual Study Start Date : August 9, 2012
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : February 2025

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

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, 3, 7, 10 years ]
  2. Implant survival and success [ Time Frame: 1, 3, 5, 7, 10 years ]
  3. rate of technical complication [ Time Frame: 1, 3, 5, 7, 10 years ]
    technical complications: screw loosenings, screw fractures, framework fractures, veneering ceramic fractures

  4. rate of biological complications [ Time Frame: 1, 3, 5, 7, 10 years ]
    biological complications: mucositis, assessed by bleeding on probing

  5. Soft tissue changes [ Time Frame: 1, 3, 5, 7, 10 years ]
    Soft tissue changes: change in clinical crown length = recession / papilla index

  6. Patient morbidity [ Time Frame: 1, 3, 5, 7, 10 years ]
    VAS scale to assess pain after implant placement

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT01649531

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Center of Dental Medicine Clinic of Reconstructive Dentistry
Zurich, Switzerland, 8032
Sponsors and Collaborators
University of Zurich
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Principal Investigator: Daniel Thoma, PD Dr. Clinic of Reconstructive Dentistry

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Responsible Party: University of Zurich Identifier: NCT01649531    
Other Study ID Numbers: 2012-0097
First Posted: July 25, 2012    Key Record Dates
Last Update Posted: November 14, 2019
Last Verified: November 2019