NCT06821308

A Randomized Controlled Clinical Trial to Assess Crestal Bone Remodeling of Four Different Implant Designs

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: University Ghent · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Accepted

Summary

This randomized controlled trial aimed to assess the effect of the implant neck design (microthreaded vs. non-microthreaded) as well as the type of abutment connection (internal conical vs. external flat-to-flat) on long-term crestal bone remodelling and peri-implant health. Four implants used for a bar-retained maxillary overdenture, were followed over a period of at least 6 years. Twenty-five patients were treated with a bar-retained maxillary overdenture. Four different implants were placed, with respectively: internal connection and microthreads on the implant neck (I MT); internal connection, without microthreads (I NMT); external connection, with microthreads (E MT); and external connection, without microthreads (E NMT). Other design features, s.a. diameter, surface topography, extent of platform switch as well as the surgical and prosthetic treatment protocol were identical. Radiographic crestal bone loss (CBL), plaque score (PS), bleeding on probing (Bop) and probing pocket depth (PPD) were determined at 1 and 6 years after implant placement.

Conditions

• Dental Implant Bone Loss

Interventions

Type	Name	Description
DEVICE	Implant placement	Each patient received 4 implants to support a bar supported overdenture. One implant is commercially available, 3 implants were experimentally made by the manufacturer for this study. The implants were similar in macro-desing, surface and platform shift but differ in microthread design and implant-abutment connection.

Timeline

• Start date: 2015-09-18
• Primary completion: 2024-02-20
• Completion: 2024-02-20
• First posted: 2025-02-11
• Last updated: 2025-02-11

Locations

1 site across 1 country: Belgium