A Prospective Multicenter Randomized Controlled Clinical Study on Conical Southern Implants With Different Thread Pitch

University Hospital, Ghent1 site in 1 country56 target enrollmentJanuary 2010

ConditionsDental Implants

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Dental Implants
Sponsor: University Hospital, Ghent
Enrollment: 56
Locations: 1
Primary Endpoint: To document the outcome of bone remodeling around IBT implants
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 2010

End Date

December 2015

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University Hospital, Ghent

Responsible Party

Sponsor

Eligibility 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

Outcomes

Primary Outcomes

To document the outcome of bone remodeling around IBT implants

Time Frame: 3 years after implantation

Secondary Outcomes

To clinically and radiographically document the placement of both IBT implant thread types in the same patient(over 2 years)
3. Outcome differences will be detected per implant center, per treated area in the mouth, per case of prosthetic rehabilitation(over 2 years)