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The trial is designed as a consecutive enrollment prospective one-center study. A minimum of 30 patients will be included in the study. At implant installation, the implant will be randomized to one of the groups (Control: conventional loading, 8 weeks; Test: early loading, 4 weeks). Samples of peri-implant crevicular fluid (PICF) and intrasulcular plaque will be collected at -14, 0 (Baseline: prosthesis delivery), 7 days and 1, 3, 6, 12 months. Prosthesis will be fabricated and delivered as usual, i.e., approximately two weeks after the impressions are taken.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early Loading | Experimental | Implant early loading: prosthesis delivery 4 weeks after implant placement |
|
| Conventional Loading | Active Comparator | Implant conventional loading: prosthesis delivery 8 weeks after implant placement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Early Loading | Procedure | The procedure in this group will consist on placing implant-supported restorations over the implants placed 4 weeks earlier. The device (dental implant) is of the same type in both groups. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical success of B+-treated dental implants after conventional or early loading protocol as described by the International Congress of Oral Implantologists, Pisa Consensus Conference, 2007 | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in marginal bone level around B+-treated implants after conventional or early loading protocol | 0 (Baseline: prosthesis delivery), 3, 6, and 12 months | |
| Change in inflammatory markers in peri-implant crevicular fluid around B+-treated implants after conventional or early loading protocol |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pablo Galindo-Moreno, DDS, PhD | Universidad de Granada | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Facultad de OdontologÃa | Granada | 18071 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33210771 | Result | Galindo-Moreno P, Gutierrez-Garrido L, Lopez-Chaichio L, Guerra-Lorenzo C, Rodriguez-Alvarez R, Padial-Molina M. Crestal bone changes around early vs. conventionally loaded implants with a multi-phosphonate coated surface: A randomized pilot clinical trial. Clin Oral Implants Res. 2021 Jan;32(1):75-87. doi: 10.1111/clr.13681. Epub 2020 Dec 18. | |
| 40062725 |
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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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| ID | Term |
|---|---|
| D057893 | Immediate Dental Implant Loading |
| ID | Term |
|---|---|
| D003758 | Dental Implantation, Endosseous |
| D003757 | Dental Implantation |
| D013516 | Oral Surgical Procedures, Preprosthetic |
| D019647 | Oral Surgical Procedures |
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| Conventional Loading | Procedure | The procedure in this group will consist on placing implant-supported restorations over the implants placed 8 weeks earlier. The device (dental implant) is of the same type in both groups. |
|
| -14, 0 (Baseline: prosthesis delivery), 7 days and 1, 3, 6, 12 months |
| Change in the microbiological profile around B+-treated implants after conventional or early loading protocol | -14 (before impressions), 0 (Baseline: prosthesis delivery), 7 days and 1, 3, 6, 12 months |
| Galindo-Moreno P, Gutierrez-Garrido L, Duarte J, Robles-Vera I, Martin-Morales N, O'Valle F, Olaechea A, Carrillo-Galvez AB, Padial-Molina M. Evolution in the Peri-Implant Oral Microbiome and Their Relationship to Long-Term Marginal Bone Loss: A Randomized Clinical Study. Clin Oral Implants Res. 2025 Jul;36(7):802-820. doi: 10.1111/clr.14426. Epub 2025 Mar 10. |
| D009066 |
| Mouth, Edentulous |
| D009059 | Mouth Diseases |
| D014076 | Tooth Diseases |
| D013514 | Surgical Procedures, Operative |
| D019919 | Prosthesis Implantation |
| D003813 | Dentistry |
| D011476 | Prosthodontics |