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The purpose of this study is to compare two different timings of restoring dental implants that are placed right after tooth extraction: The test group will have the provisional crown placed at the time of implant placement. The control group will have the tooth removed and the implant placed at the same appointment but restorations placed after 4 months. 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 timing for restoring implants for their patients. The hypothesis is that immediate restoration might increase aesthetic outcomes, e.g. less mucosal recession.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test (immediate restoration) | Experimental | Test (immediate restoration): immediate restoration will be placed on immediately placed implants. |
|
| Control: delayed restoration | Experimental | Control: delayed restoration: immediate placed implants will be restored at 4 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Test (immediate restoration) | Device | Test (immediate restoration) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Mucosal Recession Change | Mucosal level change from baseline to one year was primarily determined by an imaginary line connecting the gingival margin of the adjacent teeth. This was measured in millimeters. | Baseline, 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Radiographic Marginal Bone Level Change | Mean of mesial and distal marginal bone level changes measured by standard radiographs using customized device. This was measured in millimeters. | Baseline, 1 year |
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Inclusion Criteria:
Exclusion Criteria:
Systemic criteria:
Intraoral criteria:
CBCT criteria:
• More than 4 mm of buccal plate dehiscence is present on CBCT scans
Intraoperative criteria:
• More than 4 mm of buccal plate dehiscence is present once the tooth is extracted
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| Name | Affiliation | Role |
|---|---|---|
| Hom-Lay Wang, DDS, MSD, PhD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan School of Dentistry | Ann Arbor | Michigan | 48105 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Test (Immediate Restoration) | Test (immediate restoration): immediate restoration will be placed on immediately placed implants. Test (immediate restoration): Test (immediate restoration) |
| FG001 | Control: Delayed Restoration | Control: delayed restoration: immediate placed implants will be restored at 4 months. Control: delayed restoration: Control: delayed restoration |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Test (Immediate Restoration) | Test (immediate restoration): immediate restoration will be placed on immediately placed implants. Test (immediate restoration): Test (immediate restoration) |
| BG001 | Control: Delayed Restoration |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Mucosal Recession Change | Mucosal level change from baseline to one year was primarily determined by an imaginary line connecting the gingival margin of the adjacent teeth. This was measured in millimeters. | Two subjects withdrew from the study prior to the 1 year time point. Therefore, no data was analyzed for these two subjects. | Posted | Mean | Standard Deviation | milimeters | Baseline, 1 year |
|
Fifteen months for each subject.
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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 | Test (Immediate Restoration) | Test (immediate restoration): immediate restoration will be placed on immediately placed implants. Test (immediate restoration): Test (immediate restoration) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Issues related to tooth #30 | General disorders | Non-systematic Assessment | One subject had the crown on tooth #30 come off. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Hom-Lay Wang | University of Michigan | 734-763-3383 | homlay@umich.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 23, 2017 | Feb 12, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| ID | Term |
|---|---|
| D009057 | Stomatognathic Diseases |
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| Control: delayed restoration |
| Device |
Control: delayed restoration |
|
Control: delayed restoration: immediate placed implants will be restored at 4 months.
Control: delayed restoration: Control: delayed restoration
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
Control: delayed restoration: immediate placed implants will be restored at 4 months.
Control: delayed restoration: Control: delayed restoration
|
|
| Secondary | Radiographic Marginal Bone Level Change | Mean of mesial and distal marginal bone level changes measured by standard radiographs using customized device. This was measured in millimeters. | Two subjects withdrew from the study prior to the 1 year time point. Therefore, no data was analyzed for these two subjects. | Posted | Mean | Standard Deviation | milimeters | Baseline, 1 year |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 13 |
| 20 |
| EG001 | Control: Delayed Restoration | Control: delayed restoration: immediate placed implants will be restored at 4 months. Control: delayed restoration: Control: delayed restoration | 0 | 20 | 0 | 20 | 12 | 20 |
|
| Appendix removed | Surgical and medical procedures | Non-systematic Assessment | One subject had his appendix surgically removed. |
|
| Atrial fibrillation | Cardiac disorders | Non-systematic Assessment | One subject was treated for atrial fibrillation. |
|
| Asthma attack | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | One subject reported being treated by her primary care physician for asthma-related symptoms. |
|
| Bad taste in mouth | General disorders | Non-systematic Assessment | Two subjects reported having a bad taste in her mouth. |
|
| Bone grafting material at implant site | General disorders | Systematic Assessment | One subject had extra bone grafting particles at implant site. |
|
| Dental cavity | General disorders | Non-systematic Assessment | Two subjects reported having to have dental cavity fixed. |
|
| Blood disorder | Blood and lymphatic system disorders | Non-systematic Assessment | One subject reported going to a doctor to be tested for a blood disorder. |
|
| Falls | General disorders | Non-systematic Assessment | Two subjects reported accidentally falling and having to see their primary care physicians. |
|
| Deep vein thrombosis | Blood and lymphatic system disorders | Non-systematic Assessment | One subject reported being treated for a deep vein thrombosis. |
|
| Dehydration | General disorders | Non-systematic Assessment | One subject reported being treated for dehydration. |
|
| Gastrointestinal problems | Gastrointestinal disorders | Non-systematic Assessment | One subject reported being treated for diarrhea. One subject reported being treated for diverticulitis. |
|
| Tooth sensitivity | General disorders | Non-systematic Assessment | Two subjects reported having dental sensitivity around non-study teeth. |
|
| Tooth abscess | General disorders | Systematic Assessment | One subject had a tooth abscess on a non-study tooth. |
|
| Exudate at implant site | General disorders | Systematic Assessment | Exudate (pus) was noted at implant site. |
|
| Gum tissue tenderness | General disorders | Non-systematic Assessment | Two subjects reported having gum tissue tenderness. |
|
| Ingrown toe nail | Surgical and medical procedures | Non-systematic Assessment | One subject had an ingrown toe nail surgically removed. |
|
| Healing abutment | General disorders | Systematic Assessment | Healing abutment screw became loose. |
|
| Exposed implant | General disorders | Systematic Assessment | One subject's implant perforated the buccal plate. |
|
| Kidney stone | Renal and urinary disorders | Non-systematic Assessment | One subject was treated for a kidney stone. |
|
| Poison ivy | Skin and subcutaneous tissue disorders | Non-systematic Assessment | One subject reported being treated for poison ivy. |
|
| Flu-like symptoms | General disorders | Non-systematic Assessment | One subject reported having multiple flu-like symptoms. |
|
| Shoulder pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | One subject reported seeing her primary care physician for sports-related shoulder pain. |
|
| Shingles | Immune system disorders | Non-systematic Assessment | One subject reported being treated for shingles. |
|
| Sinus infection | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | One subject reported being treated for a sinus infection. |
|
| Gum tissue inflammation | General disorders | Systematic Assessment | One subject had a lot of gum tissue inflammation at the site of the implant. |
|
| Swelling | Blood and lymphatic system disorders | Non-systematic Assessment | One subject reported being treated for swelling in her hands and feet. |
|
| Issues with temporary crown | General disorders | Systematic Assessment | Two subjects had minor issues with their temporary crowns. |
|
| Tissue impingement | General disorders | Systematic Assessment | One subject's healing abutment was impinging on the adjacent tissue. |
|
| Broken tooth | General disorders | Non-systematic Assessment | One subject reported having a broken non-study tooth. |
|
| Tissue trauma | General disorders | Systematic Assessment | One subject had tissue trauma from eating at the site of the implant. |
|
| Twisted ankle | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Two subjects reported twisting their ankles and needing to be seen by their physicians. |
|
| Urinary track infection | Renal and urinary disorders | Non-systematic Assessment | Two subjects reported being treated for urinary track infections. |
|
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