CClinicalTrials.gg
CompletedNCT01158664Updated Dec 16, 2022

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

An interventional study of 0.6 mm tread pitch implant and 0.1 mm tread pitch implant in Dental Implants, sponsored by University Hospital, Ghent. Completed at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-12-16.

Sponsored by University Hospital, Ghent · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled Jan 2010, registered Jul 2010).
Phase
Not applicable
Study type
Interventional
Enrollment
56
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Dental Implants

Keywords

  • dental implants
  • different tread pitch design
03

In context

Lead sponsor

University Hospital, Ghent is the lead sponsor of 665 studies on the registry; 156 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
56 participants (actual)

Study arms

  • Experimental
    0.6 mm tread pitch implant

    Device: 0.6 mm tread pitch implant

  • Experimental
    0.1 mm tread pitch implant

    Device: 0.1 mm tread pitch implant

Interventions

  • Device0.6 mm tread pitch implant

    0.6 mm tread pitch implant will be used

  • Device0.1 mm tread pitch implant

    0.1 mm tread pitch implant will be used

06

What researchers measure

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

07

Study locations

1 site
  • University Hospital Ghent
    Ghent, Belgium
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 16, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01158664
Lead sponsor
University Hospital, Ghent
Responsible party
Sponsor
First posted
Jul 8, 2010
Start date
Jan 2010
Primary completion
Dec 2015
Completion
Dec 2015
Last update
Dec 16, 2022

Study contacts

Hugo De Bruyn, PhD
principal investigator · University Hospital, Ghent

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion