Complications: Inflammatory Reactions, Mechanical Complications
Conditions
Keywords
MMP-8, marginal bone level, conometric concept - Acuris, crown retention, all-ceramic crown
Brief summary
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.
Detailed description
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.
Interventions
OTHERconometric concept Acuris system
implant crown retention type using friction only
OTHERscrew retention
screw retained implant crown
OTHERcementation
cement retained implant crown
Sponsors
Medical University of Graz
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes
Inclusion criteria
* capability of giving an informed consent * good health as defined by the subjects medical history (no contraindications as described in the
Exclusion criteria
below) * age 18 to 99 years * Good periodontal status: BOP \< 20%, PI \< 30%, no PD \> 4mm * No heavy smokers (\< 10 cigarettes/day) * at least 1 missing tooth in the premolar and molar region (with at least a mesial neighboring tooth/implant showing adequate hard- and soft tissue situation without the need of crestal hard- or soft tissue augmentation) either in the maxilla or in the mandible requiring implant therapy for reconstruction, requiring sinus floor augmentation or not.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of marginal bone level | at baseline, 4 months after implant placement and 3, 6 and 12 months after restoration | assessed by single tooth x-ray; in mm |
| Change of matrix metalloproteinase 8 level | 4 months after implant placement, 3, 6 and 12 months after integration of the implant crown | biomarker for Inflammation of peri-implant disease; in ng/ml |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of probing depth (PD) | at baseline, 4, 7, 10, 16 months after implantation | using a periodontal probe; in mm |
| Number of occurrences of chipping | measured after integration of implant crown 3, 6 and 12 months after restoration | visual check |
| soft tissue maintenance | measured 4 months after implant placement and 3, 6 and 12 months after restoration | Papilla Index (Jemt T, 1997), the index ranges from 0 to 4, while 2 and 3 indicate physiological outcome |
| technician satisfaction | measured 12 months after restoration | evaluated using an individual questionnaire |
| dentist satisfaction | measured 12 months after restoration | evaluated using an individual questionnaire |
| patient satisfaction | measured at baseline, 3 and 12 months after restoration | 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). |
| Plaque Index (PI) | at baseline, 4, 7, 10 and 16 months after implantation | in percent |
| Bleeding on Probing (BOP) | at baseline, 4, 7, 10 and 16 months after implantation | in percent |
| Patient satisfaction concerning the implant crown | measured 12 months after restoration | evaluated using an individual questionnaire |
| Number of occurrences of fractures | measured after integration of implant crown 3, 6 and 12 months after restoration | visual check |
| Number of occurrences of screw loosening | measured after integration of implant crown 3, 6 and 12 months after restoration | visual check |
| Number of occurrences of crown loosening | measured after integration of implant crown 3, 6 and 12 months after restoration | visual check |
Countries
Austria
Contacts
PRINCIPAL_INVESTIGATORNorbert Jakse, UnivProfDDr
Department of Dental Medicine and Oral Health
Outcome results
None listed