Esthetic Outcomes of Immediately Placed Implants Receiving Immediate Provisionalization and Delayed Restoration
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01925339|
Recruitment Status : Active, not recruiting
First Posted : August 19, 2013
Last Update Posted : May 23, 2017
|Condition or disease||Intervention/treatment||Phase|
|Tooth Diseases Tooth Extraction Dental Implant||Device: Test (immediate restoration) Device: Control: delayed restoration||Not Applicable|
A single center, randomized controlled, parallel-arm study is planned to investigate esthetic outcomes after immediate placement and restoration in the esthetic zone. Forty adult patients who have a hopeless maxillary anterior or premolar tooth, with intact adjacent teeth will be enrolled. A signed written informed consent will be obtained after he or she has been given verbal and written information describing the nature and duration of the study. Subjects will not be screened or treated until an informed consent has been obtained. Patient information will be protected according to the privacy regulations of the Federal Health Insurance Portability and Accountability Act of 1996 (HIPAA).
The enrolled patients will be randomly placed into one of two treatment groups, immediate implant placement (IIP) and restoration group (IR) or the IIP + delayed restoration group (DR). For all patients, the hopeless tooth will be extracted atraumatically and an implant placed immediately. The decision will be made randomly to either restoring the implant immediately (Test group) with a provisional crown or restoring the implant at 4 months after implant placement (Control group). Outcome analyses will be performed until approximately 1-year after the implant surgery and primarily evaluate clinical and radiographic parameters to determine the esthetic outcomes of immediately restored IIP implants, in comparison to those immediately placed but restored in a delayed approach.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||December 2015|
|Estimated Primary Completion Date :||March 2019|
|Estimated Study Completion Date :||March 2019|
Experimental: Test (immediate restoration)
Test (immediate restoration): immediate restoration will be placed on immediately placed implants.
Device: Test (immediate restoration)
Test (immediate restoration)
Experimental: Control: delayed restoration
Control: delayed restoration: immediate placed implants will be restored at 4 months.
Device: Control: delayed restoration
Control: delayed restoration
- mucosal recession [ Time Frame: 1 year ]
- radiographic marginal bone level change [ Time Frame: 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01925339
|United States, Michigan|
|University of Michigan School of Dentistry|
|Ann Arbor, Michigan, United States, 48105|
|Principal Investigator:||Hom-Lay Wang, DDS, MSD, PhD||University of Michigan|