Peri-Implantitis, Periodontal Bone Loss, Periodontitis, Tooth Decay, Tooth Diseases, Tooth Fracture, Tooth Injuries, Tooth Loss
Conditions
Keywords
tooth socket, bone grafting, bone regeneration, dental implant, osseointegration
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.
Interventions
None listed
Sponsors
Verdugo, Fernando, DDS
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Individuals presenting alveolar Facial Bone regeneration at re-entry | 1 year | Bone regeneration of the dent-alveolar socket |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pink Esthetic Scores | 1 year | Scores 1-10: the higher the score the better the esthetic outcome. Evaluates soft tissue esthetics around the regenerated bone & implant: mesial & distal papillae, curvature of facial mucosa, level of facial mucosa, root convexity/soft tissue color & texture |
| Facial implant transparency | 1 year | Presence of implant transparency at 1 year follow-up: Yes/No |
| Band of Keratinized tissue | 1 year | Evaluation of the presence of a band of keratinized tissue around the implant: \> 2mm or \< 2mm |
| Implant crestal bone loss | 1 year | Radiographic evaluation of peri-implant marginal crestal bone loss |
Countries
United States
Outcome results
None listed