Clinical Trial: Evaluation of B+ Surface on Early Loading
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Evaluation of B+ Surface on Early Loading
Brief Summary: 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.
Detailed Summary:
Sponsor: Universidad de Granada
Current Primary Outcome: 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 [ Time Frame: 12 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Change in marginal bone level around B+-treated implants after conventional or early loading protocol [ Time Frame: 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 [ Time Frame: -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 [ Time Frame: -14 (before impressions), 0 (Baseline: prosthesis delivery), 7 days and 1, 3, 6, 12 months ]
Original Secondary Outcome: Same as current
Information By: Universidad de Granada
Dates:
Date Received: February 12, 2017
Date Started: February 20, 2017
Date Completion: July 2018
Last Updated: May 1, 2017
Last Verified: May 2017
