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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.
 
ClinicalTrials.gov Identifier: NCT01649531
Recruitment Status : Active, not recruiting
First Posted : July 25, 2012
Last Update Posted : November 14, 2019
Sponsor:
Information provided by (Responsible Party):
University of Zurich

Tracking Information
First Submitted Date  ICMJE July 20, 2012
First Posted Date  ICMJE July 25, 2012
Last Update Posted Date November 14, 2019
Actual Study Start Date  ICMJE August 9, 2012
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 20, 2012)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01649531 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 3, 2018)
  • Radiographic bone level [ Time Frame: 1, 3, 7, 10 years ]
  • Implant survival and success [ Time Frame: 1, 3, 5, 7, 10 years ]
  • rate of technical complication [ Time Frame: 1, 3, 5, 7, 10 years ]
    technical complications: screw loosenings, screw fractures, framework fractures, veneering ceramic fractures
  • rate of biological complications [ Time Frame: 1, 3, 5, 7, 10 years ]
    biological complications: mucositis, assessed by bleeding on probing
  • Soft tissue changes [ Time Frame: 1, 3, 5, 7, 10 years ]
    Soft tissue changes: change in clinical crown length = recession / papilla index
  • Patient morbidity [ Time Frame: 1, 3, 5, 7, 10 years ]
    VAS scale to assess pain after implant placement
Original Secondary Outcome Measures  ICMJE
 (submitted: July 20, 2012)
  • Radiographic bone level [ Time Frame: 1 and 3 years ]
  • Implant survival and success [ Time Frame: 1, 3, 5 years ]
  • rate of technical complication [ Time Frame: 1, 3, 5 years ]
    technical complications: screw loosenings, screw fractures, framework fractures, veneering ceramic fractures
  • rate of biological complications [ Time Frame: 1, 3, 5 years ]
    biological complications: mucositis, assessed by bleeding on probing
  • Soft tissue changes [ Time Frame: 1, 3, 5 years ]
    Soft tissue changes: change in clinical crown length = recession / papilla index
  • Patient morbidity [ Time Frame: 1, 3, 5 years ]
    VAS scale to assess pain after implant placement
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Two Implants Versus One Implant With a Cantilever - a Randomized Controlled Clinical Trial
Official Title  ICMJE Two Implants Versus One Implant With a Cantilever - a Randomized Controlled Clinical Trial
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Dental Implants
Intervention  ICMJE
  • Procedure: 1 Implant
  • Procedure: 2 Implants
Study Arms  ICMJE
  • Active Comparator: Test group
    1 Implant, to be placed in the position with greater vertical bone height with a mesial or distal cantilever.
    Intervention: Procedure: 1 Implant
  • Active Comparator: Control group
    2 Implants
    Intervention: Procedure: 2 Implants
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: April 3, 2018)
36
Original Estimated Enrollment  ICMJE
 (submitted: July 20, 2012)
34
Estimated Study Completion Date  ICMJE February 2025
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01649531
Other Study ID Numbers  ICMJE 2012-0097
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Zurich
Study Sponsor  ICMJE University of Zurich
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Daniel Thoma, PD Dr. Clinic of Reconstructive Dentistry
PRS Account University of Zurich
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP