What is the Influence of a Different Thread Pitch Design... | NCT01158664

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

NCT01158664

Sponsor

University Hospital, Ghent

Status

Completed

Last Update Posted

Dec 16, 2022Actual

Enrollment

56Actual

Phase

Not Applicable

Conditions

Dental Implants

Interventions

0.6 mm tread pitch implant
0.1 mm tread pitch implant

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2010Actual

Primary Completion Date

Dec 2015Actual

Completion Date

Dec 2015Actual

First Submitted Date

Jul 7, 2010

First Submission Date that Met QC Criteria

Jul 7, 2010

First Posted Date

Jul 8, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 14, 2022

Last Update Posted Date

Dec 16, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

56Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
0.6 mm tread pitch implant	Device	0.6 mm tread pitch implant will be used	0.6 mm tread pitch implant

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To document the outcome of bone remodeling around IBT implants		3 years after implantation

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hugo De Bruyn, PhD	University Hospital, Ghent	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Ghent		Ghent			Belgium