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Low enrollment so sponsor stopped funding the study (did not renew)
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| immediate implant placement without provisionalization | Active Comparator | 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 with immediate provisionalization | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| immediate implant placement without provisionalization | Device |
|
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Implant Survival | Checking to make sure the implant is stable. | 2wk, 4wk, 6wk, 3mo, 6mo, 12mo |
| Measure | Description | Time Frame |
|---|---|---|
| Bony Dimensional Changes | Measurements will be based off of standardized x-rays and CBCT. | Baseline, 6mo & 12mo after baseline |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. immediate implant placement without provisionalization |
| FG001 | 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. immediate implant placement with immediate provisionalization |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. immediate implant placement without provisionalization |
| BG001 | Immediate Implant Placement With Immediate Provisionalization |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Soft Tissue Diemensional Change | Tissue thickness will be measured from the digital impression and CBCT data from the hard tissue. | Data was not collected. | Posted | Baseline, 12mo after baseline |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. immediate implant placement without provisionalization |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Implant failure | Surgical and medical procedures | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Robert Eber | University of Michigan | 734-647-4023 | reber@umich.edu |
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| ID | Term |
|---|---|
| D007576 | Jaw, Edentulous, Partially |
| ID | Term |
|---|---|
| D007575 | Jaw, Edentulous |
| D007571 | Jaw Diseases |
| D009140 | Musculoskeletal Diseases |
| D009057 | Stomatognathic Diseases |
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| immediate implant placement with immediate provisionalization | Device |
|
|
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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Implant Survival | Checking to make sure the implant is stable. | Posted | Count of Participants | Participants | 2wk, 4wk, 6wk, 3mo, 6mo, 12mo |
|
|
|
| Other Pre-specified | Bony Dimensional Changes | Measurements will be based off of standardized x-rays and CBCT. | Data was not collected | Posted | Baseline, 6mo & 12mo after baseline |
|
|
| 0 |
| 2 |
| 0 |
| 2 |
| 2 |
| 2 |
| EG001 | 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. immediate implant placement with immediate provisionalization | 0 | 3 | 0 | 3 | 3 | 3 |
| Implant crown came off | General disorders | Non-systematic Assessment |
|
| UTI | General disorders | Non-systematic Assessment |
|
| Sinus Pain | General disorders | Non-systematic Assessment |
|
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| D009066 |
| Mouth, Edentulous |
| D009059 | Mouth Diseases |
| D014076 | Tooth Diseases |
| 6wk |
|
| 3mo |
|
| 6mo |
|
| 12mo |
|