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

NCT ID: NCT01917305

Last Updated: 2013-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Brief Summary

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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

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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.

Conditions

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Periimplant Crestal Bone Level Changes

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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platform-switched implant

platform-switched implant

Group Type EXPERIMENTAL

platform-shifted implant

Intervention Type DEVICE

platform-matched implant

platform-matched implant

Group Type ACTIVE_COMPARATOR

platform-shifted implant

Intervention Type DEVICE

Interventions

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platform-shifted implant

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Søren Jepsen

OTHER

Sponsor Role lead

Responsible Party

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Søren Jepsen

Professor Dr.med Dr. med.dent MS, Chair

Responsibility Role SPONSOR_INVESTIGATOR

References

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Jervoe-Storm PM, Hablutzel AS, Bartels P, Kraus D, Jepsen S, Enkling N. Comparison of irrigation protocols for the internal decontamination of dental implants-results of in vitro and in vivo studies. Clin Oral Implants Res. 2021 Oct;32(10):1168-1175. doi: 10.1111/clr.13814. Epub 2021 Aug 27.

Reference Type DERIVED
PMID: 34352143 (View on PubMed)

Enkling N, Johren P, Katsoulis J, Bayer S, Jervoe-Storm PM, Mericske-Stern R, Jepsen S. Influence of platform switching on bone-level alterations: a three-year randomized clinical trial. J Dent Res. 2013 Dec;92(12 Suppl):139S-45S. doi: 10.1177/0022034513504953. Epub 2013 Oct 24.

Reference Type DERIVED
PMID: 24158333 (View on PubMed)

Other Identifiers

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PFS3YRCT

Identifier Type: -

Identifier Source: org_study_id