This study aims to examine the inflammatory response mediated by MMP-8 (Matrix metalloproteinase-8 ) level in peri-implant sulcus fluid adjacent to screw-retained, cemented or using the Acuris-system fixed single implant crowns as well as changing of the marginal bone level within the first year after implant restoration. Furthermore periodontal parameters, patient satisfaction and possible occurring biological or technical complications will be evaluated.
After giving their written consent volunteers will be screened and eligible subjects will be randomized to three different groups. In group 1 Acuris® is used as fixation type; in group 2 screw retention, and in group 3 cementation is used. After 3 months of submerged healing the dental implants will be restored with all ceramic single implant crowns, fixed by using the randomized fixation mode. Follow-up visits till one year after implant restoration will be performed. At least 11 study visits during 16 months will be conducted.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
39
implant crown retention type using friction only
screw retained implant crown
cement retained implant crown
Medical University of Graz, Department of Dental Medicine and Oral Health, Division of Oral Surgery and Orthodontics
Graz, Austria
Change of marginal bone level
assessed by single tooth x-ray; in mm
Time frame: at baseline, 4 months after implant placement and 3, 6 and 12 months after restoration
Change of matrix metalloproteinase 8 level
biomarker for Inflammation of peri-implant disease; in ng/ml
Time frame: 4 months after implant placement, 3, 6 and 12 months after integration of the implant crown
Change of probing depth (PD)
using a periodontal probe; in mm
Time frame: at baseline, 4, 7, 10, 16 months after implantation
Number of occurrences of chipping
visual check
Time frame: measured after integration of implant crown 3, 6 and 12 months after restoration
soft tissue maintenance
Papilla Index (Jemt T, 1997), the index ranges from 0 to 4, while 2 and 3 indicate physiological outcome
Time frame: measured 4 months after implant placement and 3, 6 and 12 months after restoration
technician satisfaction
evaluated using an individual questionnaire
Time frame: measured 12 months after restoration
dentist satisfaction
evaluated using an individual questionnaire
Time frame: measured 12 months after restoration
patient satisfaction
evaluated using OHIP-G 14 questionnaire. The following dimensions are captured by the OHIP-G 14: functional Limitation (e.g., "pronouncing any words because of problems with your teeth, mouth, dentures, or jaw?") and physical Pain (e.g., "Have you had painful aching in your mouth"). 14 questions are raised, which are answered using a rating scale from 0 (never) to 4 (very often).
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Time frame: measured at baseline, 3 and 12 months after restoration
Plaque Index (PI)
in percent
Time frame: at baseline, 4, 7, 10 and 16 months after implantation
Bleeding on Probing (BOP)
in percent
Time frame: at baseline, 4, 7, 10 and 16 months after implantation
Patient satisfaction concerning the implant crown
evaluated using an individual questionnaire
Time frame: measured 12 months after restoration
Number of occurrences of fractures
visual check
Time frame: measured after integration of implant crown 3, 6 and 12 months after restoration
Number of occurrences of screw loosening
visual check
Time frame: measured after integration of implant crown 3, 6 and 12 months after restoration
Number of occurrences of crown loosening
visual check
Time frame: measured after integration of implant crown 3, 6 and 12 months after restoration