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

August 6, 2013 updated by: Søren Jepsen

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: platform-switched implant
Device: platform-shifted implant
Active Comparator: platform-matched implant
Device: platform-shifted implant

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change of vertical implant bone level
Time Frame: Implant insertion (baseline), 3 months (reopening), 4 months (crown mounting), 12, 25 and 38 months
Implant insertion (baseline), 3 months (reopening), 4 months (crown mounting), 12, 25 and 38 months

Secondary Outcome Measures

Outcome Measure
Time Frame
probing depths
Time Frame: 4, 8, 12, 25, 38 months
4, 8, 12, 25, 38 months
Bleeding
Time Frame: baseline, 4, 8, 12, 25, 38 months
baseline, 4, 8, 12, 25, 38 months
Plaque
Time Frame: baseline, 4, 8, 12, 25, 38 months
baseline, 4, 8, 12, 25, 38 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Søren Jepsen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Primary Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

July 31, 2013

First Submitted That Met QC Criteria

August 2, 2013

First Posted (Estimate)

August 6, 2013

Study Record Updates

Last Update Posted (Estimate)

August 9, 2013

Last Update Submitted That Met QC Criteria

August 6, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PFS3YRCT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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