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

S

Søren Jepsen

Status

Completed

Conditions

Periimplant Crestal Bone Level Changes

Treatments

Device: platform-shifted implant

Study type

Interventional

Funder types

Other

Identifiers

NCT01917305
PFS3YRCT

Details and patient eligibility

About

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.

Full 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.

Enrollment

25 patients

Sex

All

Ages

30 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

25 participants in 2 patient groups

platform-switched implant
Experimental group
Description:
platform-switched implant
Treatment:
Device: platform-shifted implant
platform-matched implant
Active Comparator group
Description:
platform-matched implant
Treatment:
Device: platform-shifted implant

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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