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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by University of Michigan
Sponsor:
Information provided by (Responsible Party):
Robert M. Eber, University of Michigan
ClinicalTrials.gov Identifier:
NCT02021331
First received: December 13, 2013
Last updated: December 19, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Jaw, Edentulous, Partially
Device: immediate implant placement without provisionalization
Device: immediate implant placement with immediate provisionalization
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effect of Immediate Implant Placement and Provisionalization in The Esthetic Zone: A Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Soft tissue diemensional change [ Time Frame: Baseline, 12mo after baseline ] [ Designated as safety issue: No ]
    Tissue thickness will be measured from the digital impression and CBCT data from the hard tissue.


Secondary Outcome Measures:
  • Implant survival [ Time Frame: 2wk, 4wk, 6wk, 3mo, 6mo, 12mo ] [ Designated as safety issue: No ]
    Checking to make sure the implant is stable.


Other Outcome Measures:
  • Bony dimensional changes [ Time Frame: Baseline, 6mo & 12mo after baseline ] [ Designated as safety issue: No ]
    Measurements will be based off of standardized x-rays and CBCT.


Estimated Enrollment: 30
Study Start Date: January 2013
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Device: immediate implant placement without provisionalization
Other Names:
  • BIOMET 3i Prevail Nanotite Certain - dental implant
  • Encode abutment
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.
Device: immediate implant placement with immediate provisionalization
Other Names:
  • BIOMET 3i Prevail Nanotite Certain - dental implant
  • Encode abutment

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.

  Eligibility

Ages Eligible for Study:   18 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • between 18 to 79 years old
  • in good health
  • have a 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02021331

Locations
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Andrea Cranston, RDH    734-763-3346    acransto@umich.edu   
Principal Investigator: Robert Eber, DDS         
Sponsors and Collaborators
University of Michigan
  More Information

No publications provided

Responsible Party: Robert M. Eber, Principal Investigator, University of Michigan
ClinicalTrials.gov Identifier: NCT02021331     History of Changes
Other Study ID Numbers: HUM00041254
Study First Received: December 13, 2013
Last Updated: December 19, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Michigan:
jaw, edentulous, partially

Additional relevant MeSH terms:
Jaw, Edentulous
Jaw, Edentulous, Partially
Mouth, Edentulous
Jaw Diseases
Musculoskeletal Diseases
Stomatognathic Diseases
Mouth Diseases
Tooth Diseases

ClinicalTrials.gov processed this record on July 23, 2014