Skip to content

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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06821308
Enrollment
25
Registered
2025-02-11
Start date
2015-09-18
Completion date
2024-02-20
Last updated
2025-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Implant Bone Loss

Keywords

Dental implant, crestal bone loss, microthreads, implant-abutment connection

Brief 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.

Interventions

DEVICEImplant 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.

Sponsors

University Ghent
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Intervention model description

Split-mouth study

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Crestal bone lossThe measurements were performed at 1 and 6 yearsRadiographic measurement of crestal bone loss

Secondary

MeasureTime frameDescription
PlaqueThe measurements were performed at 1 and 6 yearsPlaque was measured at 4 sites on each implant
Probing pocket depthThe measurements were performed at 1 and 6 years
Bleeding on probingThe measurements were performed at 1 and 6 years

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026