Implant loss
Conditions
Interventions
Group 1: Surgical intervention with placemant of a dental implant with 6 mm length. The implant is loaded by a single crown.
Group 2: Surgical intervention with placemant of a dental implant with 10
Sponsors
PPK Universität Zürich
Eligibility
Sex/Gender
All
Age
18 Years to 120 Years
Inclusion criteria
Inclusion criteria: • Males and females = 18 years of age. • A missing premolar or molar in either the maxilla or the mandible • Opposing dentition • Adequate bone quality and quantity at the implant site to permit the insertion of a Straumann SLActive implant of 6 or 10 mm length: Residual bone height must be at least 10 mm in the mandible (Foramen mentale, N. alveolaris inferior) and 6 mm in the maxilla (maxillary sinus). Patients will be only included if no GBR is necessary to increase alveolar bone width (slowly resorbable radio-opaque graft materials may interfere with bone level measurements). In cases, where the residual bone height in the maxilla is less than 10 mm and a 10 mm is planned, a modified summers technique is used to augment the sinus (Schmidlin et al. 2007, in press) (9). Sites will then be randomly assigned to the test (6 mm implant) or control group (10 mm implant). • Presence of a sufficient band of keratinized mucosa (min. 2 mm) to allow surgical manipulation and suturing • Signed informed consent document before being treated in the study • participants must be in good general health condition and should have no contraindications for oral surgery procedures (comprehensive medical history).
Exclusion criteria
Exclusion criteria: Pre-surgical exclusion criteria: • Systemic disease that would interfere with dental implant therapy (e.g. uncontrolled diabetes) • Any contraindications for oral surgical procedures • Current untreated periodontitis or gingivitis • Probing pocket depth of more than 4 mm at one of the adjacent teeth • Mucosal diseases (e.g. erosive lichen planus) • History of local irradiation therapy • Bone augmentation procedures with slowly resorbable radio-opaque materials • Severe bruxing or clenching habits • Heavy smokers: Patients who smoke more than 20 cigarettes per day • Conditions or circumstances, in the opinion of the investigator, which would prevent completion of study participation (compliance) • Patients with inadequate oral hygiene or unmotivated for adequate home care Exclusion Criteria at Implant Surgery • Lack of primary stability of the implant • Inappropriate implant position to insert implants according to the prosthetic requirements • Bone augmentation procedures with slowly resorbable radio-opaque materials In situations where an exclusion criterion is violated during surgery, the data of the concerned patient will be analysed in the intent to treat population. These data will be analyzed for safety parameters but will not be included in the per-protocol population. The recruited subjects will undergo radiological examination (periapical radiographs, orthopantomogram (OPT), under special circumstances a CT scan can be performed).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| implant loss according annual clinical appraisal during a follow-up period of 10 years | — |
Secondary
| Measure | Time frame |
|---|---|
| secondary outcome parameters: - periimplant pocket depth (clinical probing depth) - periimplant bone loss as assessed by x-ray foto annualy for 10 years | — |
Countries
Switzerland
Contacts
Public ContactPatrick Schmidlin
PPK Universität Zürich
Outcome results
None listed