The Cortical Shield for Facial Bone Reconstruction

The Cortical Shield for Facial Bone Reconstruction of Severely Damaged Sockets With Simultaneous Implant Placement

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

Study Overview

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

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 Type: Observational
• Enrollment (Actual): 34

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90077
      • Fernando Verdugo, DDS, Corp

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients requiring single implants to replace missing teeth to restore masticatory function and esthetics. Options of immediate or delay placement will be chosen based on the current status of the site to be restored at the time of referral.

The present cross-sectional quasi-experimental study is conducted in a specialty clinic in accordance to the requirements of the 1964 Helsinki Declaration

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Immediate; implants are placed immediately after tooth extraction
Delayed; implants are placed months after the tooth has been extracted

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Individuals presenting alveolar Facial Bone regeneration at re-entry	Bone regeneration of the dent-alveolar socket	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pink Esthetic Scores	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	1 year
Facial implant transparency	Presence of implant transparency at 1 year follow-up: Yes/No	1 year
Band of Keratinized tissue	Evaluation of the presence of a band of keratinized tissue around the implant: > 2mm or < 2mm	1 year
Implant crestal bone loss	Radiographic evaluation of peri-implant marginal crestal bone loss	1 year

Collaborators and Investigators

• Sponsor: Verdugo, Fernando, DDS
• Investigators: Principal Investigator: Fernando Verdugo, PhD, University of Sacro Cuore

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2019
• Primary Completion (Actual): March 31, 2021
• Study Completion (Actual): April 5, 2021

Study Registration Dates

• First Submitted: March 29, 2021
• First Submitted That Met QC Criteria: March 29, 2021
• First Posted (Actual): April 1, 2021

Study Record Updates

• Last Update Posted (Actual): April 8, 2021
• Last Update Submitted That Met QC Criteria: April 5, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: dental implant; bone grafting; osseointegration; bone regeneration; tooth socket
• Additional Relevant MeSH Terms: Wounds and Injuries; Musculoskeletal Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Bone Diseases; Periodontal Atrophy; Bone Resorption; Periodontitis; Tooth Loss; Peri-Implantitis; Alveolar Bone Loss; Tooth Diseases; Tooth Fractures; Tooth Injuries
• Other Study ID Numbers: Ver152007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No