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

University Ghent

Status: Completed

Conditions: Dental Implant Bone Loss

Treatments: Device: Implant placement

Study type: Interventional

Funder types: Other

Identifiers

NCT06821308

EC/2015/0338/AM02

Details and patient eligibility

About

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.

Enrollment: 25 patients

Sex: All

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Edentulous in the maxilla and sufficient bone to harvest four 4 x 9 mm implant

Exclusion criteria

• Head -and neck radiation
• Bisphosphonate intake
• Limited prosthetic height

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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25 participants in 4 patient groups

Internal Microthread implant

Active Comparator group

Description:

Each participant received 4 implants, one of each type

Treatment:

Device: Implant placement

Internal Non Microthread implant

Experimental group

Treatment:

Device: Implant placement

External microthread implant

Experimental group

Treatment:

Device: Implant placement

External Non-Microthread implant

Experimental group

Treatment:

Device: Implant placement