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Influence of Platform-switching on Bone Level Alterations: a 3 Year Randomized Clinical Trial (RCT).

Influence of Platform-switching on Bone Level Alterations: a 3 Year RCT.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01917305
Enrollment
25
Registered
2013-08-06
Start date
2007-02-28
Completion date
Unknown
Last updated
2013-08-09

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

Conditions

Periimplant Crestal Bone Level Changes

Keywords

Bacteria, bone level, bone loss, dental implants, implant design, platform-shifting, platform-matching

Brief summary

The concept of platform-switching has been introduced to implant dentistry based on clinical observations of reduced periimplant crestal bone loss. However, published available data are controversial and most studies are limited to 12 months. The aim of the present RCT was to test the hypothesis that platform-switching has a positive impact on crestal bone level changes after 3 years.

Detailed description

Two implants with a diameter of 4 mm were inserted crestally in the posterior mandible of 25 subjects. After three months of submerged healing, single-tooth crowns were randomly placed, either with (3.3mm platform, test) or without platform-switching (4mm platform, control). Patients were followed up at short intervals for monitoring of healing an oral hygiene. Statistical analysis for the influence of time and platform-type on bone levels employed the Brunner-Langer Model.

Interventions

DEVICEplatform-shifted implant

Sponsors

Søren Jepsen
Lead SponsorOTHER

Study design

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

Eligibility

Sex/Gender
ALL
Age
30 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* good general health * edentulous gap in the posterior mandible for placement of 2 implants * sufficient bone height above the alveolar nerve for placement of implants with a height of 9.5mm * bone width for placement of implants with diameter of 4mm * at least 4mm keratinized mucosa * medium or a thick soft tissue biotype

Exclusion criteria

* infectious disease * diabetes or osteopathy * active periodontitis * medication influencing bone metabolism * lactating or pregnant women

Design outcomes

Primary

MeasureTime frame
Change of vertical implant bone levelImplant insertion (baseline), 3 months (reopening), 4 months (crown mounting), 12, 25 and 38 months

Secondary

MeasureTime frame
probing depths4, 8, 12, 25, 38 months
Bleedingbaseline, 4, 8, 12, 25, 38 months
Plaquebaseline, 4, 8, 12, 25, 38 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026