The Cortical Shield for Facial Bone Reconstruction
1 other identifier
observational
34
1 country
1
Brief Summary
To evaluate a novel technique of bone regeneration and simultaneous implant placement in severely damaged sockets.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jan 2019
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 3, 2019
CompletedFirst Submitted
Initial submission to the registry
March 29, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2021
CompletedFirst Posted
Study publicly available on registry
April 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 5, 2021
CompletedApril 8, 2021
April 1, 2021
2.2 years
March 29, 2021
April 5, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Individuals presenting alveolar Facial Bone regeneration at re-entry
Bone regeneration of the dent-alveolar socket
1 year
Secondary Outcomes (4)
Pink Esthetic Scores
1 year
Facial implant transparency
1 year
Band of Keratinized tissue
1 year
Implant crestal bone loss
1 year
Study Arms (2)
Immediate
implants are placed immediately after tooth extraction
Delayed
implants are placed months after the tooth has been extracted
Eligibility Criteria
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
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fernando Verdugo, DDS, Corp
Los Angeles, California, 90077, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Fernando Verdugo, PhD
University of Sacro Cuore
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDIV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 29, 2021
First Posted
April 1, 2021
Study Start
January 3, 2019
Primary Completion
March 31, 2021
Study Completion
April 5, 2021
Last Updated
April 8, 2021
Record last verified: 2021-04
Data Sharing
- IPD Sharing
- Will not share