NCT01158664

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 7, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 8, 2010

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

December 16, 2022

Status Verified

December 1, 2022

Enrollment Period

5.9 years

First QC Date

July 7, 2010

Last Update Submit

December 14, 2022

Conditions

Dental Implants

Keywords

dental implantsdifferent tread pitch design

Outcome Measures

Primary Outcomes (1)

  • To document the outcome of bone remodeling around IBT implants

    3 years after implantation

Secondary Outcomes (2)

  • 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

Study Arms (2)

0.6 mm tread pitch implant

EXPERIMENTAL
Device: 0.6 mm tread pitch implant

0.1 mm tread pitch implant

EXPERIMENTAL
Device: 0.1 mm tread pitch implant

Interventions

0.6 mm tread pitch implantDEVICE

0.6 mm tread pitch implant will be used

0.6 mm tread pitch implant
0.1 mm tread pitch implantDEVICE

0.1 mm tread pitch implant will be used

0.1 mm tread pitch implant

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Ghent

Ghent, Belgium

Location

Related Links

Study Officials

  • Hugo De Bruyn, PhD

    University Hospital, Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 7, 2010

First Posted

July 8, 2010

Study Start

January 1, 2010

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

December 16, 2022

Record last verified: 2022-12

Locations

BE(1)