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
|Condition or disease||Intervention/treatment||Phase|
|Jaw, Edentulous, Partially||Device: immediate implant placement without provisionalization Device: immediate implant placement with immediate provisionalization||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Effect of Immediate Implant Placement and Provisionalization in The Esthetic Zone: A Randomized Clinical Trial|
|Actual Study Start Date :||December 2012|
|Actual Primary Completion Date :||April 2016|
|Actual Study Completion Date :||April 2016|
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
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
- Soft Tissue Diemensional Change [ Time Frame: Baseline, 12mo after baseline ]Tissue thickness will be measured from the digital impression and CBCT data from the hard tissue.
- Implant Survival [ Time Frame: 2wk, 4wk, 6wk, 3mo, 6mo, 12mo ]Checking to make sure the implant is stable.
- Bony Dimensional Changes [ Time Frame: Baseline, 6mo & 12mo after baseline ]Measurements will be based off of standardized x-rays and CBCT.
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): NCT02021331
|United States, Michigan|
|University of Michigan|
|Ann Arbor, Michigan, United States, 48109|