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Clinical Trials/DRKS00016500
DRKS00016500
Completed
未知

Prospective clinical study to evaluate the clinical performance of immediately placed PL implants: A monocenter study - PL study

Johann Wolfgang Goethe Universität FrankfurtZentrum der Zahn-, Mund- und KieferheilkundeCarolinum Zahnärztliches Universitäts-Institut gGmbHPoliklinik für Zahnärztliche Chirurgie und Implantologie0 sites25 target enrollmentJanuary 8, 2019

Overview

Phase
未知
Intervention
Not specified
Conditions
K08.1
Sponsor
Johann Wolfgang Goethe Universität FrankfurtZentrum der Zahn-, Mund- und KieferheilkundeCarolinum Zahnärztliches Universitäts-Institut gGmbHPoliklinik für Zahnärztliche Chirurgie und Implantologie
Enrollment
25
Status
Completed
Last Updated
last year

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
January 8, 2019
End Date
TBD
Last Updated
last year
Study Type
Interventional
Sex
All

Investigators

Sponsor
Johann Wolfgang Goethe Universität FrankfurtZentrum der Zahn-, Mund- und KieferheilkundeCarolinum Zahnärztliches Universitäts-Institut gGmbHPoliklinik für Zahnärztliche Chirurgie und Implantologie

Eligibility Criteria

Inclusion Criteria

  • 1\. Males and females with an age of 18 to 69 years
  • 2\. Planned single tooth replacement in maxilla (14\-24 FDI) allowing the placement of a single implant
  • 3\. Adjacent teeth have to be free of acute or chronical infections (e.g. periodontal or endodontic problems)
  • 4\. Single tooth gaps (i.e. natural tooth roots present on the sides adjacent to the implant)
  • 5\. Opposing dentition must be natural teeth or fixed restoration
  • 6\. Subject shall have a stable occlusal relationship
  • 7\. Patient has been informed of the follow\-up visits and is willing to return to the clinical center for these follow\-up visits
  • 8\. Subjects must have voluntarily signed the informed consent form before any study related action

Exclusion Criteria

  • 1\. Systemic disease that would interfere with dental implant therapy (e.g. uncontrolled diabetes)
  • 2\. Any contraindications for oral surgical procedures (according to instruction for use of implant system)
  • 3\. Patients who smoke \>10 cigarettes per day or cigar equivalents, or who chew tobacco
  • 4\. Bone metabolism disorders
  • 5\. Uncontrolled para\-functional diseases (bruxism, clenching or grinding of teeth)
  • 6\. Disorders that impede the ability of patients to maintain adequate oral hygiene
  • 7\. 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
  • 8\. Any implant that cannot be immediately provisionalized or receive an individual healing abutment and need to be submerged healed will be excluded from the study
  • 9\. Pregnant or breastfeeding women

Outcomes

Primary Outcomes

Not specified

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