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Clinical Trials/DRKS00018852
DRKS00018852
Recruiting
N/A

Prospective clinical study to evaluate the clinical performance of immediately loaded PURE ceramic implants.A monocentric study - PURE 121

Poliklinik für Zahnärztliche Chirurgie und Implantologie, ZZMK, Carolinum Zahnärztliches Universitäts-Institut gGmbH, Johann Wolfgang Goethe Universität Frankfurt0 sites25 target enrollmentSeptember 27, 2019

Overview

Phase
N/A
Intervention
Not specified
Conditions
Not specified
Sponsor
Poliklinik für Zahnärztliche Chirurgie und Implantologie, ZZMK, Carolinum Zahnärztliches Universitäts-Institut gGmbH, Johann Wolfgang Goethe Universität Frankfurt
Enrollment
25
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
September 27, 2019
End Date
TBD
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Poliklinik für Zahnärztliche Chirurgie und Implantologie, ZZMK, Carolinum Zahnärztliches Universitäts-Institut gGmbH, Johann Wolfgang Goethe Universität Frankfurt

Eligibility Criteria

Inclusion Criteria

  • Being in need of at least one implant for the replacement of missing or non retainable teeth in the upper or lower jaw (in regions 16 to 26 or in the lower jaw in regions 36 to 46, excluding regions 12 and 22 as well as 32,31,42 and 41 FDI (narrow gaps), due to diameter limitations of the implant investigated)
  • \- Adjacent teeth and/or implants have to be free of acute or chronical infections (e.g. periodontal or endodontic problems,peri\-implantitis)
  • \- Single tooth gaps (i.e. natural tooth roots or implants present on the sides adjacent to the implant)
  • \- Opposing dentition must be natural teeth or fixed restoration
  • \- Subject shall have a stable occlusal relationship
  • \- Patient has been informed of the follow\-up visits and is willing to return to the clinical center for these follow\-up visits
  • \- Subjects must have voluntarily signed the informed consent form before any study related action

Exclusion Criteria

  • \- Systemic disease that would interfere with dental implant therapy (e.g. uncontrolled 1\. diabetes)
  • \- Any contraindications for oral surgical procedures (according to instruction for use of implant system)
  • \- Patients who smoke \>10 cigarettes per day or cigar equivalents, or who chew Tobacco
  • \- Bone metabolism disorders
  • \- Uncontrolled para\-functional diseases (bruxism, clenching or grinding of teeth)
  • \- Disorders that impede the ability of patients to maintain adequate oral hygiene
  • \- Conditions or circumstances, in the opinion of the investigator, which would prevent completion of study participation or interfere with analysis of study results, such as history of non\-compliance or unreliability
  • \- Any patient with placed implant that cannot be immediately provisionalized or receive an individual healing abutment and need to be submerged healed
  • \- Need of extended bone augmentation before or during implant placement
  • \- Pregnant or breastfeeding women

Outcomes

Primary Outcomes

Not specified

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