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Clinical Trials/DRKS00031320
DRKS00031320
Recruiting
Not 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 enrollmentApril 5, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
K08.1
Sponsor
Poliklinik für Zahnärztliche Prothetik
Enrollment
50
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
April 5, 2023
End Date
TBD
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Eligibility 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.
  • 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

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.

Outcomes

Primary Outcomes

Not specified

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