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

Recruiting

• Conditions: K08.1; K00.0; Loss of teeth due to accident, extraction or local periodontal disease; Anodontia

• Registration Number: DRKS00031320
• Lead Sponsor: Poliklinik für Zahnärztliche Prothetik

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-05
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 50

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

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.

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
technical and biological complications of implant-borne crowns in service.<br>Patient reported outcome