The Cortical Shield for Facial Bone Reconstruction

Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04827693
• Other study ID #: Ver152007
• Status: Completed
• Start date: January 3, 2019
• Est. completion date: April 5, 2021

Study information

• Verified date: April 2021
• Source: Verdugo, Fernando, DDS
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: April 5, 2021
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Alveolar Bone Loss
• Peri-Implantitis
• Periodontal Bone Loss
• Periodontitis
• Tooth Decay
• Tooth Diseases
• Tooth Fracture
• Tooth Fractures
• Tooth Injuries
• Tooth Loss

Locations

Country	Name	City	State
United States	Fernando Verdugo, DDS, Corp	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Verdugo, Fernando, DDS

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Individuals presenting alveolar Facial Bone regeneration at re-entry	Bone regeneration of the dent-alveolar socket	1 year
Secondary	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
Secondary	Facial implant transparency	Presence of implant transparency at 1 year follow-up: Yes/No	1 year
Secondary	Band of Keratinized tissue	Evaluation of the presence of a band of keratinized tissue around the implant: > 2mm or < 2mm	1 year
Secondary	Implant crestal bone loss	Radiographic evaluation of peri-implant marginal crestal bone loss	1 year