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RecruitingNot ApplicableNCT04276246

Supplementary Implants Supporting Conventional Removable Dental Prosthesis (RDPs) in Kennedy Class I

Supplementary Implants Supporting Conventional RDPs in Kennedy Class I: A Dual-centered Randomized Controlled Trial

Sponsor

University Hospital, Basel, Switzerland

Enrollment

12 participants

Start Date

Feb 6, 2020

Study Type

INTERVENTIONAL

Conditions

Partial Edentulism Kennedy Class 1

Summary

In this study the additional effect of supplementary implants in patients with Kennedy Class I in terms of patient-reported outcome measures (PROMs) and cost-benefit-analyses comparing costs of maintenance care will be investigated

Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • Subjects must have voluntarily signed the informed consent before any study action, are willing and able to attend scheduled follow-up visits, and agree that the encoded data will be collected and analyzed
  • Males and females with at least 18 years of age
  • intraoral situation with bilateral edentulous areas located posterior to the remaining natural teeth (Kennedy class I) in the upper or lower jaw
  • remaining dentition includes a first premolar, canine or incisor as the most posterior tooth

Exclusion Criteria7

  • Uncontrolled systemic disease that would interfere with dental implant therapy;
  • Patients who smoke \> 10 cigarettes per day or tobacco equivalents;
  • Patients with alcohol and/or drug abuse;
  • Patients with chronic pain;
  • Patients with untreated periodontitis and / or inadequate oral hygiene (Plaque Index \< 30%);
  • Medical conditions requiring chronic high dose steroid therapy or anti-resorptive treatment;
  • Conditions or circumstances, in the opinion of the investigators, which would prevent completion of study participation or interfere with analysis of study results such as history of non-compliance or unreliability.
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Interventions

DEVICEdental implants and retentive implant components

retentive components (Group A Test), which are connected to the implants to retain the RPD

DEVICEdental implants and supportive implant components

supportive components (Group B Control), which are connected to the implants to support the RPD

Locations(1)

Department of Reconstructive Dentistry, University Center for Dental Medicine Basel UZB, University of Basel

Basel, Switzerland

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NCT04276246