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

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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Jaw, Edentulous, Partially
Interventions Device: immediate implant placement without provisionalization
Device: immediate implant placement with immediate provisionalization
Enrollment 5
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Immediate Implant Placement Without Provisionalization Immediate Implant Placement With Immediate Provisionalization
Hide Arm/Group 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.

immediate implant placement without 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.

immediate implant placement with immediate provisionalization

Period Title: Overall Study
Started 2 3
Completed 2 1
Not Completed 0 2
Reason Not Completed
Adverse Event             0             2
Arm/Group Title Immediate Implant Placement Without Provisionalization Immediate Implant Placement With Immediate Provisionalization Total
Hide Arm/Group 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.

immediate implant placement without 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.

immediate implant placement with immediate provisionalization

Total of all reporting groups
Overall Number of Baseline Participants 2 3 5
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 3 participants 5 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
2
 100.0%
2
  66.7%
4
  80.0%
>=65 years
0
   0.0%
1
  33.3%
1
  20.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 3 participants 5 participants
Female
2
 100.0%
1
  33.3%
3
  60.0%
Male
0
   0.0%
2
  66.7%
2
  40.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 2 participants 3 participants 5 participants
2 3 5
1.Primary Outcome
Title Soft Tissue Diemensional Change
Hide Description Tissue thickness will be measured from the digital impression and CBCT data from the hard tissue.
Time Frame Baseline, 12mo after baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not collected.
Arm/Group Title Immediate Implant Placement Without Provisionalization Immediate Implant Placement With Immediate Provisionalization
Hide Arm/Group 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.

immediate implant placement without 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.

immediate implant placement with immediate provisionalization

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Implant Survival
Hide Description Checking to make sure the implant is stable.
Time Frame 2wk, 4wk, 6wk, 3mo, 6mo, 12mo
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Immediate Implant Placement Without Provisionalization Immediate Implant Placement With Immediate Provisionalization
Hide Arm/Group 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.

immediate implant placement without 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.

immediate implant placement with immediate provisionalization

Overall Number of Participants Analyzed 2 3
Measure Type: Count of Participants
Unit of Measure: Participants
2wk
2
 100.0%
3
 100.0%
4wk
2
 100.0%
2
  66.7%
6wk
2
 100.0%
1
  33.3%
3mo
2
 100.0%
1
  33.3%
6mo
2
 100.0%
1
  33.3%
12mo
2
 100.0%
1
  33.3%
3.Other Pre-specified Outcome
Title Bony Dimensional Changes
Hide Description Measurements will be based off of standardized x-rays and CBCT.
Time Frame Baseline, 6mo & 12mo after baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not collected
Arm/Group Title Immediate Implant Placement Without Provisionalization Immediate Implant Placement With Immediate Provisionalization
Hide Arm/Group 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.

immediate implant placement without 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.

immediate implant placement with immediate provisionalization

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Immediate Implant Placement Without Provisionalization Immediate Implant Placement With Immediate Provisionalization
Hide Arm/Group 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.

immediate implant placement without 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.

immediate implant placement with immediate provisionalization

All-Cause Mortality
Immediate Implant Placement Without Provisionalization Immediate Implant Placement With Immediate Provisionalization
Affected / at Risk (%) Affected / at Risk (%)
Total   0/2 (0.00%)      0/3 (0.00%)    
Hide Serious Adverse Events
Immediate Implant Placement Without Provisionalization Immediate Implant Placement With Immediate Provisionalization
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/2 (0.00%)      0/3 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Immediate Implant Placement Without Provisionalization Immediate Implant Placement With Immediate Provisionalization
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/2 (100.00%)      3/3 (100.00%)    
General disorders     
Implant crown came off *  1/2 (50.00%)  1 0/3 (0.00%)  0
UTI *  0/2 (0.00%)  0 1/3 (33.33%)  1
Sinus Pain *  1/2 (50.00%)  1 0/3 (0.00%)  0
Surgical and medical procedures     
Implant failure *  0/2 (0.00%)  0 2/3 (66.67%)  2
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Robert Eber
Organization: University of Michigan
Phone: 734-647-4023
EMail: reber@umich.edu
Layout table for additonal information
Responsible Party: Robert M. Eber, University of Michigan
ClinicalTrials.gov Identifier: NCT02021331    
Other Study ID Numbers: HUM00041254
First Submitted: December 13, 2013
First Posted: December 27, 2013
Results First Submitted: March 20, 2017
Results First Posted: April 28, 2017
Last Update Posted: July 11, 2017