The Cortical Shield for Facial Bone Reconstruction

Completed

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

• Registration Number: NCT04827693
• Lead Sponsor: Verdugo, Fernando, DDS

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.

Study Timeline

• Study Start: 2019-01-03
• Study First Submitted: 2021-03-29
• Study First Submitted QC: 2021-03-29
• Primary Completion: 2021-03-31
• Status Verified: 2021-04
• Study First Posted: 2021-04-01
• Study Completion: 2021-04-05
• Last Update Submitted: 2021-04-05
• Last Update Posted: 2021-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Individuals presenting alveolar Facial Bone regeneration at re-entry	1 year	Bone regeneration of the dent-alveolar socket

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Fernando Verdugo, DDS, Corp; 🇺🇸 Los Angeles, California, United States