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Completed

NCT Number: NCT01917305

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

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.

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Key information

Conditions

Periimplant Crestal Bone Level Changes Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

platform-shifted implant

Device

Primary outcomes

  1. Change of vertical implant bone level

    Time frame: Implant insertion (baseline), 3 months (reopening), 4 months (crown mounting), 12, 25 and 38 months

Secondary outcomes

  1. probing depths

    Time frame: 4, 8, 12, 25, 38 months

  2. Bleeding

    Time frame: baseline, 4, 8, 12, 25, 38 months

  3. Plaque

    Time frame: baseline, 4, 8, 12, 25, 38 months

Sponsors and collaborators

Lead sponsor

Søren Jepsen

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2010
First posted
Aug 6, 2013
Registry last updated
Aug 9, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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