Tooth LossNCT04827693
The Cortical Shield for Facial Bone Reconstruction
An observational study of Tooth Loss and Tooth Diseases, run by Verdugo, Fernando, DDS at 1 site in United States.
Trial summary
To evaluate a novel technique of bone regeneration and simultaneous implant placement in severely damaged sockets. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tooth Loss, Tooth Diseases, Tooth Fracture
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jan 2019to 5 Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Fernando Verdugo, DDS, Corp
Los Angeles, California, 90077
About this study
Official title: 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.
Read the 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.
- Conditions
- Tooth Loss, Tooth Diseases, Tooth Fracture, Tooth Injuries, Periodontal Bone Loss, Periodontitis
- Keywords
- tooth socket, bone grafting, bone regeneration, dental implant, osseointegration
- Medical subject headings
- Tooth Loss, Tooth Diseases, Tooth Fractures, Tooth Injuries, Alveolar Bone Loss, Periodontitis, Peri-Implantitis, Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Immediate | implants are placed immediately after tooth extraction | |
| Delayed | implants are placed months after the tooth has been extracted |
What is being measured
The primary outcome is the main question the study is designed to answer.
Individuals presenting alveolar Facial Bone regeneration at re-entry
Bone regeneration of the dent-alveolar socket
Measured: 1 year
Secondary outcomes (4)
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
Measured: 1 year
Facial implant transparency
Presence of implant transparency at 1 year follow-up: Yes/No
Measured: 1 year
Band of Keratinized tissue
Evaluation of the presence of a band of keratinized tissue around the implant: > 2mm or < 2mm
Measured: 1 year
Implant crestal bone loss
Radiographic evaluation of peri-implant marginal crestal bone loss
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start3 Jan 2019
- Primary completion31 Mar 2021
- Study completion5 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Verdugo, Fernando, DDS
- Responsible party
- Sponsor
- Investigators
- Fernando Verdugo, PhD, Principal investigator, University of Sacro Cuore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04827693
- Sponsor's protocol ID
- Ver152007
- Status last verified
- Apr 2021
- First submitted
- 29 Mar 2021
- Last updated
- 8 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Cortical Shield for Facial Bone Reconstruction of Severely Damaged Sockets With Simultaneous Implant Placement
- ClinicalTrials.gov ID
- NCT04827693
- Acronym / sponsor ID
- Ver152007
- Conditions
- Tooth Loss, Tooth Diseases, Tooth Fracture, Tooth Injuries, Periodontal Bone Loss, Periodontitis
- Keywords
- tooth socket, bone grafting, bone regeneration, dental implant, osseointegration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Verdugo, Fernando, DDS
- Study start
- 3 Jan 2019 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 5 Apr 2021 (actual)
- First posted
- 1 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate | – | –implants are placed immediately after tooth extraction |
| Delayed | – | –implants are placed months after the tooth has been extracted |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- Individuals with untreated \& generalized severe periodontitis
- Heavy smokers (>10 cigarettes/day)
- Poor oral hygiene
- Diabetes (HbA1C >6.5% as cutoff value)
- Uncontrolled cardiovascular disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Individuals presenting alveolar Facial Bone regeneration at re-entry
Time frame: 1 year
Bone regeneration of the dent-alveolar socket
4 secondary outcomes
Pink Esthetic Scores
Time frame: 1 year
Facial implant transparency
Time frame: 1 year
Band of Keratinized tissue
Time frame: 1 year
Implant crestal bone loss
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2021.
- Individual participant dataSharing planned: No
Related trials for Tooth Loss
Not yet recruitingObservational study
Russian Version of OHIP-EDENT-19 for Adults With Complete Tooth Loss
Edentulism
Enrolling by invitation
Investigation of the Effect of Horizontal Platelet Rich Fibrin Placed in Tooth Extraction Sockets on Bone Formation
Tooth Loss, Dental Implant Failed
RecruitingObservational study
Changes in Oral Health-related Quality of Life (OHRQoL) During Full Arch Implant Treatment
Edentulous Mouth, Quality of Life
Recruiting
Effect of Collagen Membrane on Ridge Preservation
Dehiscence, Tooth Extraction
Not yet recruiting
Immediate vs Conventional Loading With Different Crown Materials on Immediately Placed Single Implants
Partial Edentulism, Dental Implant
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fernando Verdugo, PhD principal investigator
University of Sacro Cuore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tooth Loss and Tooth Diseases, run by Verdugo, Fernando, DDS at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Individuals presenting alveolar Facial Bone regeneration at re-entry (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2021.