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Clinical Investigation of single-tooth implants and retained crowns made from additive manufactured hybrid composites for permanent replacement of missing posterior teeth.

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00031320
Enrollment
50
Registered
2023-04-05
Start date
2023-09-27
Completion date
Unknown
Last updated
2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

K08.1 K00.0

Interventions

Group 1: Procedure: 0. preliminary examination 1. restoration with a "Semados RSXpro" implant in the jawbone of the posterior region X. Mucosa-covered healing over ~3 months 2. reopening of the muco
2,3,4) - tooth status visual (0,4) - visual quality assessment of the crown (3,4) - clinically indicated radiograph (0,1,3,4
in total 4 images)

Sponsors

Poliklinik für Zahnärztliche Prothetik
Lead Sponsor

Eligibility

Sex/Gender
All
Age
26 Years to 70 Years

Inclusion criteria

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. Maximum: 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

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.

Design outcomes

Primary

MeasureTime frame
Osseointegration of implants: - radiographic bone level from plattform to tip: >90% - Periotest-Value <07 Function of crown: - USPHD-criteria <Charlie - Ryge criteria: Sierra or Romeo

Secondary

MeasureTime frame
technical and biological complications of implant-borne crowns in service. Patient reported outcome

Countries

Germany

Contacts

Public ContactFabian Hüttig

Poliklinik für Zahnärztliche Prothetik

fabian.huettig@med.uni-tuebingen.de+49 7071 29 83983

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 7, 2026