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The Effect of Immediate Implant Placement and Provisionalization in the Esthetic Zone (3i)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02021331
Recruitment Status : Terminated (Low enrollment so sponsor stopped funding the study (did not renew))
First Posted : December 27, 2013
Results First Posted : April 28, 2017
Last Update Posted : July 11, 2017
Sponsor:
Information provided by (Responsible Party):
Robert M. Eber, University of Michigan

Tracking Information
First Submitted Date  ICMJE December 13, 2013
First Posted Date  ICMJE December 27, 2013
Results First Submitted Date  ICMJE March 20, 2017
Results First Posted Date  ICMJE April 28, 2017
Last Update Posted Date July 11, 2017
Actual Study Start Date  ICMJE December 2012
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 19, 2013)
Soft Tissue Diemensional Change [ Time Frame: Baseline, 12mo after baseline ]
Tissue thickness will be measured from the digital impression and CBCT data from the hard tissue.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 19, 2013)
Implant Survival [ Time Frame: 2wk, 4wk, 6wk, 3mo, 6mo, 12mo ]
Checking to make sure the implant is stable.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: December 19, 2013)
Bony Dimensional Changes [ Time Frame: Baseline, 6mo & 12mo after baseline ]
Measurements will be based off of standardized x-rays and CBCT.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE The Effect of Immediate Implant Placement and Provisionalization in the Esthetic Zone
Official Title  ICMJE The Effect of Immediate Implant Placement and Provisionalization in The Esthetic Zone: A Randomized Clinical Trial
Brief Summary The purpose of this study is to compare two different techniques of placing dental implants: 1) removing the tooth and placing the implant immediately and 2) removing the tooth and placing both the implant and a temporary crown immediately. Both procedures currently are accepted methods for replacing missing teeth but direct comparisons of the two procedures are lacking. The results of this study should aid clinicians in selecting the best implant placement technique for their patients.
Detailed Description

To qualify, patients must be between 18 to 79 years old, in good health, have a tooth in the upper jaw (except molars) that needs to be extracted, and able and willing to return to the University of Michigan Dental School for all follow-up appointments (8 follow-up visits over a period of 12 months). Sufficient number of natural teeth and/or replacements to provide a stable occlusion as determined by the investigator

Patients will be excluded for any of the following conditions: Women who are pregnant or plan to become pregnant, an existing implant adjacent to the area of study, current smoker or quit smoking less than one year ago, antibiotic therapy for more than two weeks within 3 months of baseline, need for antibiotics prior to dental treatment (due to prosthetic joint replacement or other medical condition), chronic use of medications known to affect the gum tissues (calcium channel blocker (less than 6 months, or over 6 months and have experienced overgrowth of your gums), anticonvulsants, immunosuppressive drugs, nonsteroidal anti-inflammatory medications...), current orthodontic treatment, or active periodontal treatment. Participants must inform the investigators if they are enrolled in any other studies because it may becloud them from participation in this study.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Jaw, Edentulous, Partially
Intervention  ICMJE
  • Device: immediate implant placement without provisionalization
    Other Names:
    • BIOMET 3i Prevail Nanotite Certain - dental implant
    • Encode abutment
  • Device: immediate implant placement with immediate provisionalization
    Other Names:
    • BIOMET 3i Prevail Nanotite Certain - dental implant
    • Encode abutment
Study Arms  ICMJE
  • Active Comparator: immediate implant placement without provisionalization
    The subject will have the tooth removed and an implant placed right away. In this arm the subject will have no temporary crown on the implant.
    Intervention: Device: immediate implant placement without provisionalization
  • Experimental: immediate implant placement with immediate provisionalization
    The subject will have the tooth removed and an implant placed right away. In this arm the subject will get a temporary crown on the implant.
    Intervention: Device: immediate implant placement with immediate provisionalization
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: March 20, 2017)
5
Original Estimated Enrollment  ICMJE
 (submitted: December 19, 2013)
30
Actual Study Completion Date  ICMJE April 2016
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • between 18 to 79 years old
  • in good health
  • have a single tooth in the upper jaw (except molars) that needs to be extracted
  • able and willing to return to the University of Michigan Dental School for all follow-up appointments (8 follow-up visits over a period of 12 months)
  • Sufficient number of natural teeth and/or replacements to provide a stable occlusion as determined by the investigator

Exclusion Criteria:

  • an existing implant adjacent to the area of study
  • current smoker or quit smoking less than one year ago
  • antibiotic therapy for more than two weeks within 3 months of baseline, need for antibiotics prior to dental treatment (due to prosthetic joint replacement or other medical condition)
  • chronic use of medications known to affect the gum tissues (calcium channel blocker (less than 6 months, or over 6 months and have experienced overgrowth of your gums), anticonvulsants, immunosuppressive drugs, nonsteroidal anti-inflammatory medications...)
  • current orthodontic treatment, or active periodontal treatment
  • Women who are pregnant or plan to become pregnant during the course of the study, and nursing mothers
  • unstable medical condition or if you are unable to have routine dental surgery then you should not participate in this study. If you are already participating in another study, we ask that you inform the investigators because participating in more than one study may be harmful to you.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 79 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02021331
Other Study ID Numbers  ICMJE HUM00041254
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Robert M. Eber, University of Michigan
Study Sponsor  ICMJE University of Michigan
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Michigan
Verification Date June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP