Evaluation of B+ Surface on Early Loading
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Universidad de Granada
- Enrollment
- 34
- Locations
- 1
- Primary Endpoint
- 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
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Early Loading
Implant early loading: prosthesis delivery 4 weeks after implant placement
Intervention: Early Loading (Procedure)
Conventional Loading
Implant conventional loading: prosthesis delivery 8 weeks after implant placement
Intervention: Conventional Loading (Procedure)
Outcomes
Primary Outcomes
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
Secondary Outcomes
- 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 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)
- 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)
Investigators
Pablo Galindo-Moreno
Professor
Universidad de Granada