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

Participant Flow

Recruitment Details
Pre-assignment Details


Arm/Group Title	Immediate Implant Placement Without Provisionalization	Immediate Implant Placement With Immediate Provisionalization
Arm/Group Description	The subject will have the tooth rem...	The subject will have the tooth rem...
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

Baseline Characteristics

Arm/Group Title		Immediate Implant Placement Without Provisionalization	Immediate Implant Placement With Immediate Provisionalization	Total
Arm/Group Description		The subject will have the tooth rem...	The subject will have the tooth rem...	Total of all reporting groups
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
Baseline Analysis Population Description		[Not Specified]
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
United States		2	3	5

Outcome Measures

1.Primary Outcome


Title	Soft Tissue Diemensional Change
Description	Tissue thickness will be measured from the digital impression and CBCT...
Description	Tissue thickness will be measured from the digital impression and CBCT data from the hard tissue.
Time Frame	Baseline, 12mo after baseline

Outcome Measure Data

Analysis Population Description

Data was not collected.


Arm/Group Title	Immediate Implant Placement Without Provisionalization	Immediate Implant Placement With Immediate Provisionalization
Arm/Group Description:	The subject will have the tooth rem...	The subject will have the tooth rem...
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
Description	Checking to make sure the implant is stable.
Description	Checking to make sure the implant is stable.
Time Frame	2wk, 4wk, 6wk, 3mo, 6mo, 12mo

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Immediate Implant Placement Without Provisionalization	Immediate Implant Placement With Immediate Provisionalization
Arm/Group Description:	The subject will have the tooth rem...	The subject will have the tooth rem...
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
Description	Measurements will be based off of standardized x-rays and CBCT.
Description	Measurements will be based off of standardized x-rays and CBCT.
Time Frame	Baseline, 6mo & 12mo after baseline

Outcome Measure Data

Analysis Population Description

Data was not collected


Arm/Group Title	Immediate Implant Placement Without Provisionalization	Immediate Implant Placement With Immediate Provisionalization
Arm/Group Description:	The subject will have the tooth rem...	The subject will have the tooth rem...
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.

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]

Arm/Group Title	Immediate Implant Placement Without Provisionalization		Immediate Implant Placement With Immediate Provisionalization
Arm/Group Description	The subject will have the tooth rem...		The subject will have the tooth rem...
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%)
Serious Adverse Events 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%)
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

Limitations and Caveats

[Not Specified]

More Information

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

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