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

Primary Purpose

Jaw, Edentulous, Partially

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
immediate implant placement without provisionalization
immediate implant placement with immediate provisionalization
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Jaw, Edentulous, Partially focused on measuring jaw, edentulous, partially

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Michigan

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

immediate implant placement without provisionalization

immediate implant placement with immediate provisionalization

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Soft Tissue Diemensional Change
Tissue thickness will be measured from the digital impression and CBCT data from the hard tissue.

Secondary Outcome Measures

Implant Survival
Checking to make sure the implant is stable.

Full Information

First Posted
December 13, 2013
Last Updated
June 8, 2017
Sponsor
University of Michigan
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1. Study Identification

Unique Protocol Identification Number
NCT02021331
Brief Title
The Effect of Immediate Implant Placement and Provisionalization in the Esthetic Zone
Acronym
3i
Official Title
The Effect of Immediate Implant Placement and Provisionalization in The Esthetic Zone: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Terminated
Why Stopped
Low enrollment so sponsor stopped funding the study (did not renew)
Study Start Date
December 2012 (Actual)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Jaw, Edentulous, Partially
Keywords
jaw, edentulous, partially

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
immediate implant placement without provisionalization
Arm Type
Active Comparator
Arm Description
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.
Arm Title
immediate implant placement with immediate provisionalization
Arm Type
Experimental
Arm Description
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 Type
Device
Intervention Name(s)
immediate implant placement without provisionalization
Other Intervention Name(s)
BIOMET 3i Prevail Nanotite Certain - dental implant, Encode abutment
Intervention Type
Device
Intervention Name(s)
immediate implant placement with immediate provisionalization
Other Intervention Name(s)
BIOMET 3i Prevail Nanotite Certain - dental implant, Encode abutment
Primary Outcome Measure Information:
Title
Soft Tissue Diemensional Change
Description
Tissue thickness will be measured from the digital impression and CBCT data from the hard tissue.
Time Frame
Baseline, 12mo after baseline
Secondary Outcome Measure Information:
Title
Implant Survival
Description
Checking to make sure the implant is stable.
Time Frame
2wk, 4wk, 6wk, 3mo, 6mo, 12mo
Other Pre-specified Outcome Measures:
Title
Bony Dimensional Changes
Description
Measurements will be based off of standardized x-rays and CBCT.
Time Frame
Baseline, 6mo & 12mo after baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States

12. IPD Sharing Statement

Learn more about this trial

The Effect of Immediate Implant Placement and Provisionalization in the Esthetic Zone

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