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To evaluate immediate implant placement feasibility and esthetic outcomes in severely damaged sockets that received simultaneously bone reconstruction (cortical bone shield) and implant placement versus intact sockets that needed no reconstruction and had immediate implant placement.
The present clinical trial aims at demonstrating facial bone regeneration on sites that presented large buccal bone dehiscences & vertical bone loss and evaluate the feasibility of performing simultaneous bone augmentation and implant placement, comparing the outcomes with sites that had intact sockets that did not require reconstruction. A secondary objective was to evaluate pink esthetics and marginal bone levels at final follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate implant placement without reconstruction | Other | Immediate implant placement after tooth extraction |
|
| Immediate implant placement with reconstruction | Other | Immediate implant placement and simultaneous bone reconstruction after tooth extraction |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| implant placement | Procedure | autogenous bone reconstruction of damaged socket & simultaneous implant placement |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate implant placement feasibility & success rate at 12 months | evaluate implant success following Karoussis et al. success criteria | 12 months |
| Number of individuals with low pink esthetic outcomes as assessed by pink esthetic scores (PES) | pink esthetics scores (PES) as proposed by Belser et al. Values 0-10 were 10 is the best esthetic outcome. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Implant transparency: clinical presence or absence | Visual evaluation of facial mucosal implant transparency at 12 months: positive or negative | 12 months |
| Number of participants with >0.2mm of marginal bone levels |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Verdugo, PhD | Verdugo, Fernando, DDS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| FV, DDS,Corp | San Gabriel | California | 91776 | United States |
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| ID | Term |
|---|---|
| D016388 | Tooth Loss |
| D016301 | Alveolar Bone Loss |
| D009057 | Stomatognathic Diseases |
| D057873 | Peri-Implantitis |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D014076 | Tooth Diseases |
| D001862 | Bone Resorption |
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|
evaluate radiographic marginal bone levels at 12 months with >0.2mm of bone loss
| 12 months |
| Band of keratinized tissue: clinical presence or absence | evaluate the presence of facial keratinized tissue on the implant sites >2 or <2mm | 12 months |
| D001847 |
| Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D055093 | Periodontal Atrophy |