DRKS00031320RecruitingNot Applicable
Clinical Investigation of single-tooth implants and retained crowns made from additive manufactured hybrid composites for permanent replacement of missing posterior teeth. - RSX+AM-SIC
Poliklinik für Zahnärztliche Prothetik0 sites50 target enrollmentStarted: April 5, 2023Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 50
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 26 Years to 70 Years (—)
- Sex
- All
Inclusion Criteria
- •Permanent residence in max. 50km vicinity; foreseeable for the next 2 years.
- •Need for fixed prosthetics in one or both jaws:
- •At least one interdental gap or free-end gap in the posterior region with space available and need for
- •- One or two single tooth implants with a fixed crown.
- •2 implants per jaw
- •2 implants per patient
- •Good oral hygiene: PI <50
- •Willingness to participate on a participation basis after deduction of statutory health insurance subsidies of
- •approx. 500 EUR for 1 implant
- •resp.800 EUR for 2 implants
- •incl. crown restoration.
Exclusion Criteria
- •Tobacco consumption >10 cigarettes per day
- •Diabetes with HbA1c = 7.0
- •Limited legal capacity, current pregnancy
- •Acute or refractory chronic periodontitis or presence of peri-implantitis.
- •Large-volume bone defect requiring two-stage augmentation specifically:
- •- Lack of bone supply of vertically < 11 mm to the anatom. structure and oro-vestibular width <6 mm as well as sagittal width <6 mm
- •- Exceeding the implant-to-crown ratio of 1:2.5
- •Signs of dysfunction/bruxism (DC/TMD criteria) or recurrent orofacial pain, traumatic occlusion in the sense of severe abrasion of the occlusal surfaces or ubiquitous wedge-shaped lesions.
- •Need for removable dentures in the same jaw.
- •Severe limitations of the general condition as oral chir. Risk factors esp.
- •- Need for endocarditis prophylaxis
- •- Tumour disease of the oral cavity
- •- Radiotherapy in the head and/or neck region
- •- Taking medicines that influence bone growth (oral bisphosphonates, monoclonal antibodies against bone metabolism (e.g. denosumab))
- •Multi-allergic patients, unstable CHD, neurological impairments of motor function and cognition)
- •Infectious disease(s), especially relevant titres of hepatitis C virus, HIV, tuberculosis, H1N1, EHEC.
- •Known psychotic or severe affective disorders with regular inpatient treatment.
Investigators
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