Influence of Platform-switching on Bone Level Alterations: a 3 Year RCT.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Periimplant Crestal Bone Level Changes
- Sponsor
- Søren Jepsen
- Enrollment
- 25
- Primary Endpoint
- Change of vertical implant bone level
- Status
- Completed
- Last Updated
- 12 years ago
Overview
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.
Investigators
Søren Jepsen
Professor Dr.med Dr. med.dent MS, Chair
University Hospital, Bonn
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
Outcomes
Primary Outcomes
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
- Plaque(baseline, 4, 8, 12, 25, 38 months)
- probing depths(4, 8, 12, 25, 38 months)
- Bleeding(baseline, 4, 8, 12, 25, 38 months)