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What is the Influence of a Different Thread Pitch Design on Bone Remodelling Around Conical Southern Oral Implants?

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ClinicalTrials.gov Identifier: NCT01158664
Recruitment Status : Unknown
Verified December 2014 by University Hospital, Ghent.
Recruitment status was:  Recruiting
First Posted : July 8, 2010
Last Update Posted : December 5, 2014
Sponsor:
Information provided by (Responsible Party):
University Hospital, Ghent

Tracking Information
First Submitted Date  ICMJE July 7, 2010
First Posted Date  ICMJE July 8, 2010
Last Update Posted Date December 5, 2014
Study Start Date  ICMJE January 2010
Estimated Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 7, 2010)
To document the outcome of bone remodeling around IBT implants [ Time Frame: 3 years after implantation ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01158664 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 7, 2010)
  • To clinically and radiographically document the placement of both IBT implant thread types in the same patient [ Time Frame: over 2 years ]
  • 3. Outcome differences will be detected per implant center, per treated area in the mouth, per case of prosthetic rehabilitation [ Time Frame: over 2 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE What is the Influence of a Different Thread Pitch Design on Bone Remodelling Around Conical Southern Oral Implants?
Official Title  ICMJE A Prospective Multicenter Randomized Controlled Clinical Study on Conical Southern Implants With Different Thread Pitch
Brief Summary Patients who need more than 2 dental implants will be treated by the same implant type (conical 4mm diameter IBT Southern implants) but with different thread pitch design (0,6mm en 1,0mm type). In a 3 year clinical follow up period, the bone remodelling on X-rays is registered around these implants. The role of the thread pitch design will be investigated.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Dental Implants
Intervention  ICMJE
  • Device: 0.6 mm tread pitch implant
    0.6 mm tread pitch implant will be used
  • Device: 0.1 mm tread pitch implant
    0.1 mm tread pitch implant will be used
Study Arms
  • Experimental: 0.6 mm tread pitch implant
    Intervention: Device: 0.6 mm tread pitch implant
  • Experimental: 0.1 mm tread pitch implant
    Intervention: Device: 0.1 mm tread pitch implant
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 Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 7, 2010)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date December 2015
Estimated Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • At least 18 years old
  • Periodontally-healthy or periodontally-treated patients
  • Smokers are included
  • All types of prosthetic indications are accepted but 2 IBT type implants with different threads have to be placed in one patient on the same day. Implants can be connected or not connected in the same jaw.

Exclusion Criteria:

  • All other contra indications for implant surgery
  • Guided bone regeneration or use of any substitutes
  • No implantation in regenerated or augmented bone
  • No immediate loading cases
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01158664
Other Study ID Numbers  ICMJE 2009/649
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University Hospital, Ghent
Study Sponsor  ICMJE University Hospital, Ghent
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Hugo De Bruyn, PhD University Hospital, Ghent
PRS Account University Hospital, Ghent
Verification Date December 2014

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