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

Dental Implants Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01158664
• Other study ID #: 2009/649
• Status: Completed
• Phase: N/A
• Start date: January 2010
• Est. completion date: December 2015

Study information

• Verified date: December 2022
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dental Implants

Intervention

Device:
• 0.6 mm tread pitch implant
0.6 mm tread pitch implant will be used
• 0.1 mm tread pitch implant
0.1 mm tread pitch implant will be used

Locations

Country	Name	City	State
Belgium	University Hospital Ghent	Ghent

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To document the outcome of bone remodeling around IBT implants		3 years after implantation
Secondary	To clinically and radiographically document the placement of both IBT implant thread types in the same patient		over 2 years
Secondary	3. Outcome differences will be detected per implant center, per treated area in the mouth, per case of prosthetic rehabilitation		over 2 years

External Links

•   website of University Hospital Ghent, Belgium