The Cortical Shield for Facial Bone Reconstruction of Severely Damaged Sockets With Simultaneous Implant Placement
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Tooth Loss
- Sponsor
- Verdugo, Fernando, DDS
- Enrollment
- 34
- Locations
- 1
- Primary Endpoint
- Individuals presenting alveolar Facial Bone regeneration at re-entry
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
To evaluate a novel technique of bone regeneration and simultaneous implant placement in severely damaged sockets.
Detailed Description
Patients requiring a single implant, presenting severe facial bone loss as a result of previous infection, failed socket grafting or trauma, will enter this cross-sectional study. Socket reconstruction and simultaneous implant placement will be performed through periosteal-guided bone regeneration (PGBR). Implant timing: immediate or delayed. Implants will be encased in a customized shield of autogenous cortical bone harvested from an adjacent site. A re-entry surgery will be performed at 12-17-weeks to evaluate bone regeneration. Peri-implant tissues will be assessed following established success criteria. Implants will be evaluated for the presence of Periimplantitis.
Investigators
Eligibility Criteria
Inclusion Criteria
- •ASA1 or ASA2 (American Society of Anesthesiologists)
- •Healthy individuals with good oral hygiene and motivation
- •No systemic uncontrolled diseases
- •Not taking drugs known to modify bone metabolism
Exclusion Criteria
- •Individuals with untreated \& generalized severe periodontitis
- •Heavy smokers (\>10 cigarettes/day)
- •Poor oral hygiene
- •Diabetes (HbA1C \>6.5% as cutoff value)
- •Uncontrolled cardiovascular disease
- •Poor overall health (ASA IV)
Outcomes
Primary Outcomes
Individuals presenting alveolar Facial Bone regeneration at re-entry
Time Frame: 1 year
Bone regeneration of the dent-alveolar socket
Secondary Outcomes
- Pink Esthetic Scores(1 year)
- Facial implant transparency(1 year)
- Band of Keratinized tissue(1 year)
- Implant crestal bone loss(1 year)