Clinical trial NCT01917305: Influence of Platform-switching on Bone Level Alterations: a 3 Year Randomized Clinical Trial (RCT).
Official title: Influence of Platform-switching on Bone Level Alterations: a 3 Year RCT.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periimplant Crestal Bone Level Changes
Keywords: Bacteria
bone level
bone loss
dental implants
implant design
platform-shifting
platform-matching
Lead sponsor: University Hospital, Bonn
Sponsor class: OTHER
First posted: 2013-08-06
Enrollment: 25
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change of vertical implant bone level
timeFrame: Implant insertion (baseline), 3 months (reopening), 4 months (crown mounting), 12, 25 and 38 months
Secondary outcomes:
measure: probing depths
timeFrame: 4, 8, 12, 25, 38 months
measure: Bleeding
timeFrame: baseline, 4, 8, 12, 25, 38 months
measure: Plaque
timeFrame: baseline, 4, 8, 12, 25, 38 months
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 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.