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

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effect of Immediate Implant Placement and Provisionalization in The Esthetic Zone: A Randomized Clinical Trial

Conditions
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Jaw, Edentulous, Partially

Intervention / Treatment
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* Device: immediate implant placement without provisionalization
* Device: immediate implant placement with immediate provisionalization


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: immediate implant placement without provisionalization<br>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<br> <br> * Other names: Encode abutment;|
| Experimental: immediate implant placement with immediate provisionalization<br>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<br> <br> * Other names: Encode abutment;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implant Survival | Checking to make sure the implant is stable. | 2wk, 4wk, 6wk, 3mo, 6mo, 12mo | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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jaw, edentulous, partially