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Comprehensive Alveolar and Tooth Esthetic Replacement

December 2, 2019

Overview

The purpose of this study is to evaluate whether including an allogeneic gum graft (a graft from an external donor) during dental implant therapy improves implant health and appearance.

 

Study Information

This clinical trial will involve an estimated 60 participants who will be randomly divided into one of two groups. Participants will either receive or not receive a supplemental gum graft along with the implant. They will also be asked to complete a brief oral health questionnaire. Participants will return to the clinic about 8 weeks post surgery for digital crown impressions and again at 11-13 weeks after surgery for crown placement. They will also return to clinic at 1 year after implant placement for implant evaluation. This study began on August 25th 2019 and is estimated to be completed by July 1st 2021. 

 

Inclusion Criteria

 

  • At least 18 years of age
  • Willing and able to provide informed consent
  • In need of one implant to replace a missing tooth
  • At least 20 teeth in good repair and occlusion
  • Sufficient bone volume for dental implant placement without required bone augmentation
  • Site development (soft and/or bone tissue) performed at least 5 months before implant placement, when required

 

Exclusion Criteria

 

  • Current smoker
  • Implant cannot be placed without bone graft
  • Unable to pay for crown
  • Untreated rampant caries and/or uncontrolled periodontitis
  • Absence of adjacent (mesial and/or distal) natural tooth
  • Uncontrolled diabetes
  • Systemic or local disease or condition that would compromise post-operative healing and/or osseointegration
  • use of bisphosphonates
  • History of radiation in the head and neck region
  • Unable or unwilling to return for follow-up visits
  • Unrealistic esthetic or functional demands
  • Unlikely to be able to comply with study procedures
  • Unwilling or unable to provide informed consent

 

Location

This study is taking place at the University of Illinois at Chicago College of Dentistry, Chicago, Illinois, United States, 60611. For more information please contact Susan Ferguson, MS on 312-996-7226 or at DentCRC@uic.edu.

 

Sponsors/Collaborators

This study is sponsored by the University of Illinois at Chicago and Dentsply Sirona Implants. Lyndon F Cooper, Associate Dean of Research, Chair-Dept. of Oral Biology, University of Illinois at Chicago is the Principal Investigator.

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