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

• ClinicalTrials.gov Identifier: NCT02021331
• Recruitment Status: Terminated
• First Posted: December 27, 2013
• Results First Posted: April 28, 2017
• Last Update Posted: July 11, 2017
• Sponsor: University of Michigan
• Information provided by (Responsible Party): Robert M. Eber, University of Michigan

Tracking Information

• First Submitted Date: December 13, 2013
• First Posted Date: December 27, 2013
• Results First Submitted Date: March 20, 2017
• Results First Posted Date: April 28, 2017
• Last Update Posted Date: July 11, 2017
• Actual Study Start Date: December 2012
• Actual Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: 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: The Effect of Immediate Implant Placement and Provisionalization in the Esthetic Zone
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Jaw, Edentulous, Partially

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: March 20, 2017): 5
• Original Estimated Enrollment (submitted: December 19, 2013): 30
• Actual Study Completion Date: April 2016
• Actual Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 18 Years to 79 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02021331
• Other Study ID Numbers: HUM00041254
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Robert M. Eber, University of Michigan
• Study Sponsor: University of Michigan
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: University of Michigan
• Verification Date: June 2017