Evaluation of B+ Surface on Early Loading

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of B+ Surface on Early Loading

Conditions
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Jaw, Edentulous, Partially

Intervention / Treatment
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* Procedure: Early Loading
* Procedure: Conventional Loading


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient >18 and ≤75 years old One missing tooth in the premolar or molar area with both opposing and adjacent teeth (mesial and distal). Exclusion Criteria: One-stage bone augmentation Heavy smokers (>10 cigarettes/day) Uncontrolled type 1 or 2 diabetes (HgA1c>8) Known auto-immune or inflammatory disease Severe hematologic disorders, such as hemophilia or leukemia Local or systemic infection that may compromise normal healing (e.g., extensive periapical pathology) Liver or kidney dysfunction/failure Currently receiving cancer treatment or within 18 months from completion of radio- or chemotherapy Long-term history of oral bisphosphonates use (i.e., 10 years or more) History of intravenous bisphosphonates Long-term (>3 months) history of antibiotics or drugs known to alter the inflammation and/or immunological system Severe osseous diseases (e.g., Paget disease of bone) Pregnant women or nursing mothers Not able or not willing to follow instructions related to the study procedures

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early Loading<br>Implant early loading: prosthesis delivery 4 weeks after implant placement | Procedure: Early Loading<br>* 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.<br>|
| Active Comparator: Conventional Loading<br>Implant conventional loading: prosthesis delivery 8 weeks after implant placement | Procedure: Conventional Loading<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | -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 |