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OpenTrials
Completed

NCT Number: NCT01158664

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

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.

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Key information

Conditions

Dental Implants

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Ghent

Ghent, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

0.6 mm tread pitch implant

Device

0.6 mm tread pitch implant will be used

0.1 mm tread pitch implant

Device

0.1 mm tread pitch implant will be used

Primary outcomes

  1. To document the outcome of bone remodeling around IBT implants

    Time frame: 3 years after implantation

Secondary outcomes

  1. To clinically and radiographically document the placement of both IBT implant thread types in the same patient

    Time frame: over 2 years

  2. 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

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Jul 8, 2010
Registry last updated
Dec 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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