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

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

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.

Study Overview

• Status: Completed
• Conditions: Dental Implants
• Intervention / Treatment: Device: 0.6 mm tread pitch implant; Device: 0.1 mm tread pitch implant

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Ghent, Belgium
    • University Hospital Ghent

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 0.6 mm tread pitch implant	Device: 0.6 mm tread pitch implant; 0.6 mm tread pitch implant will be used
Experimental: 0.1 mm tread pitch implant	Device: 0.1 mm tread pitch implant; 0.1 mm tread pitch implant will be used

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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	over 2 years

Collaborators and Investigators

• Sponsor: University Hospital, Ghent
• Investigators: Principal Investigator: Hugo De Bruyn, PhD, University Hospital, Ghent

Publications and helpful links

Helpful Links

• website of University Hospital Ghent, Belgium

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2010
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: July 7, 2010
• First Submitted That Met QC Criteria: July 7, 2010
• First Posted (Estimate): July 8, 2010

Study Record Updates

• Last Update Posted (Actual): December 16, 2022
• Last Update Submitted That Met QC Criteria: December 14, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: dental implants; different tread pitch design
• Other Study ID Numbers: 2009/649