The Cortical Shield for Facial Bone Reconstruction

Verdugo, Fernando, DDS

Status: Completed

Conditions: Tooth Injuries; Periodontitis; Tooth Loss; Tooth Decay; Tooth Fracture; Periodontal Bone Loss; Peri-Implantitis; Tooth Diseases

Study type: Observational

Identifiers

NCT04827693

Ver152007

Details and patient eligibility

About

To evaluate a novel technique of bone regeneration and simultaneous implant placement in severely damaged sockets.

Full 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.

Enrollment: 34 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

34 participants in 2 patient groups

Immediate

Description:

implants are placed immediately after tooth extraction

Delayed

Description:

implants are placed months after the tooth has been extracted