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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.
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
History of Changes
  Purpose

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.


Condition Intervention
Dental Implants
 Device: 0.6 mm tread pitch implant
Device: 0.1 mm tread pitch implant

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Prospective Multicenter Randomized Controlled Clinical Study on Conical Southern Implants With Different Thread Pitch

Resource links provided by NLM:

Drug Information available for: Rosin
U.S. FDA Resources

Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • To document the outcome of bone remodeling around IBT implants [ Time Frame: 3 years after implantation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 50
Study Start Date: January 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 0.6 mm tread pitch implant Device: 0.6 mm tread pitch implant
0.6 mm tread pitch implant will be used
Experimental: 0.1 mm tread pitch implant Device: 0.1 mm tread pitch implant
0.1 mm tread pitch implant will be used

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01158664

Contacts
Contact: Hugo De Bruyn, PhD hugo.debruyn@ugent.be

Locations
Belgium
University Hospital Ghent Recruiting
Ghent, Belgium
Principal Investigator: Hugo De Bruyn, PhD            
Sub-Investigator: Eric Thevissen            
Sub-Investigator: Jan Cosyn            
Sub-Investigator: Stefan Vandeweghe            
Sponsors and Collaborators
University Hospital, Ghent
Investigators
Principal Investigator: Hugo De Bruyn, PhD University Hospital, Ghent
  More Information

Additional Information:
website of University Hospital Ghent, Belgium  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT01158664     History of Changes
Other Study ID Numbers: 2009/649
Study First Received: July 7, 2010
Last Updated: February 1, 2013
Health Authority: Belgium: Ethics Committee

Keywords provided by University Hospital, Ghent:
dental implants
different tread pitch design

ClinicalTrials.gov processed this record on May 23, 2013