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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by University Hospital, Ghent
Sponsor:
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT01158664
First received: July 7, 2010
Last updated: February 1, 2013
Last verified: February 2013

July 7, 2010
February 1, 2013
January 2010
December 2013   (final data collection date for primary outcome measure)
To document the outcome of bone remodeling around IBT implants [ Time Frame: 3 years after implantation ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01158664 on ClinicalTrials.gov Archive Site
  • To clinically and radiographically document the placement of both IBT implant thread types in the same patient [ Time Frame: over 2 years ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
What is the Influence of a Different Thread Pitch Design on Bone Remodelling Around Conical Southern Oral Implants?
A Prospective Multicenter Randomized Controlled Clinical Study on Conical Southern Implants With Different Thread Pitch

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Dental Implants
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
December 2013
December 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Hugo De Bruyn, PhD hugo.debruyn@ugent.be
Belgium
 
NCT01158664
2009/649
No
University Hospital, Ghent
University Hospital, Ghent
Not Provided
Principal Investigator: Hugo De Bruyn, PhD University Hospital, Ghent
University Hospital, Ghent
February 2013

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