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

University Ghent25 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Dental Implant Bone Loss

Interventions

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.

Eligibility

Sex: ALLMin age: 21 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Ghent University

Ghent, Belgium

Outcomes

Primary Outcomes

Crestal bone loss

Radiographic measurement of crestal bone loss

Time frame: The measurements were performed at 1 and 6 years

Secondary Outcomes

Plaque

Plaque was measured at 4 sites on each implant

Time frame: The measurements were performed at 1 and 6 years

Probing pocket depth

Time frame: The measurements were performed at 1 and 6 years

Bleeding on probing

Time frame: The measurements were performed at 1 and 6 years

Data from ClinicalTrials.gov

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