Tooth LossNCT05157009
Immediate Implant Outcomes With and Without Bone Augmentation
A study testing implant placement in people with Tooth Loss and Bone Loss, Alveolar, run by Verdugo, Fernando, DDS at 1 site in United States.
Trial summary
To evaluate immediate implant placement feasibility and esthetic outcomes in severely damaged sockets that received simultaneously bone reconstruction (cortical bone shield) and implant placement versus intact sockets that needed no reconstruction and had immediate implant placement. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tooth Loss, Bone Loss, Alveolar, Dental Diseases
- What is being tested?
- implant placement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2021to 31 Dec 2023
- Phase
- Interventional
- 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- individuals 20 Years and older
- Patients requiring single implants to replace missing teeth to restore masticatory function and esthetics.
- 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
- Smokers (>5 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.
About this study
Official title: Immediate Implants in Damaged Sockets With Simultaneous Bone Reconstruction vs. Immediate Implants in Intact Sockets and no Reconstruction
To evaluate immediate implant placement feasibility and esthetic outcomes in severely damaged sockets that received simultaneously bone reconstruction (cortical bone shield) and implant placement versus intact sockets that needed no reconstruction and had immediate implant placement.
Read the detailed description
The present clinical trial aims at demonstrating facial bone regeneration on sites that presented large buccal bone dehiscences \& vertical bone loss and evaluate the feasibility of performing simultaneous bone augmentation and implant placement, comparing the outcomes with sites that had intact sockets that did not require reconstruction. A secondary objective was to evaluate pink esthetics and marginal bone levels at final follow-up.
- Conditions
- Tooth Loss, Bone Loss, Alveolar, Dental Diseases, Dental Trauma
- Being tested
- implant placement
- Keywords
- immediate dental implant, dental implant, bone regeneration, peri-implantitis
- Medical subject headings
- Tooth Loss, Alveolar Bone Loss, Stomatognathic Diseases, Peri-Implantitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
implant placementProcedure or surgery
Also called bone reconstruction
autogenous bone reconstruction of damaged socket \& simultaneous implant placement
| Study group | Role | What they receive |
|---|---|---|
| Immediate implant placement without reconstruction | Other | Immediate implant placement after tooth extraction Receives: Procedure: implant placement |
| Immediate implant placement with reconstruction | Other | Immediate implant placement and simultaneous bone reconstruction after tooth extraction Receives: Procedure: implant placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate implant placement feasibility & success rate at 12 months
evaluate implant success following Karoussis et al. success criteria
Measured: 12 months
Number of individuals with low pink esthetic outcomes as assessed by pink esthetic scores (PES)
pink esthetics scores (PES) as proposed by Belser et al. Values 0-10 were 10 is the best esthetic outcome.
Measured: 12 months
Secondary outcomes (3)
Implant transparency: clinical presence or absence
Visual evaluation of facial mucosal implant transparency at 12 months: positive or negative
Measured: 12 months
Number of participants with >0.2mm of marginal bone levels
evaluate radiographic marginal bone levels at 12 months with >0.2mm of bone loss
Measured: 12 months
Band of keratinized tissue: clinical presence or absence
evaluate the presence of facial keratinized tissue on the implant sites >2 or <2mm
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2021
- Study start1 Oct 2021
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Verdugo, Fernando, DDS
- Responsible party
- Sponsor
- Investigators
- Verdugo, PhD, Principal investigator, Verdugo, Fernando, DDS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05157009
- Sponsor's protocol ID
- VerdugoF
- Status last verified
- Apr 2023
- First submitted
- 8 Nov 2021
- Last updated
- 26 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Implants in Damaged Sockets With Simultaneous Bone Reconstruction vs. Immediate Implants in Intact Sockets and no Reconstruction
- ClinicalTrials.gov ID
- NCT05157009
- Acronym / sponsor ID
- VerdugoF
- Conditions
- Tooth Loss, Bone Loss, Alveolar, Dental Diseases, Dental Trauma
- Keywords
- immediate dental implant, dental implant, bone regeneration, peri-implantitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Verdugo, Fernando, DDS
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 14 Dec 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 immediate implant placement feasibility and esthetic outcomes in severely damaged sockets that received simultaneously bone reconstruction (cortical bone shield) and implant placement versus intact sockets that needed no reconstruction and had immediate implant placement.
Detailed description
The present clinical trial aims at demonstrating facial bone regeneration on sites that presented large buccal bone dehiscences \& vertical bone loss and evaluate the feasibility of performing simultaneous bone augmentation and implant placement, comparing the outcomes with sites that had intact sockets that did not require reconstruction. A secondary objective was to evaluate pink esthetics and marginal bone levels at final follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate implant placement without reconstruction | Other | Procedure: implant placementImmediate implant placement after tooth extraction |
| Immediate implant placement with reconstruction | Other | Procedure: implant placementImmediate implant placement and simultaneous bone reconstruction after tooth extraction |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- individuals 20 Years and older
- Patients requiring single implants to replace missing teeth to restore masticatory function and esthetics.
- ASA1 or ASA2 (American Society of Anesthesiologists)
- Healthy individuals with good oral hygiene and motivation
- No systemic uncontrolled diseases
Key exclusion criteria (6 listed)
- Individuals with untreated \& generalized severe periodontitis
- Smokers (>5 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| implant placementAlso: bone reconstructionautogenous bone reconstruction of damaged socket \& simultaneous implant placement | Procedure or surgery | Immediate implant placement with reconstruction, Immediate implant placement without reconstruction |
Primary outcome
Evaluate implant placement feasibility & success rate at 12 months
Time frame: 12 months
evaluate implant success following Karoussis et al. success criteria
Number of individuals with low pink esthetic outcomes as assessed by pink esthetic scores (PES)
Time frame: 12 months
pink esthetics scores (PES) as proposed by Belser et al. Values 0-10 were 10 is the best esthetic outcome.
3 secondary outcomes
Implant transparency: clinical presence or absence
Time frame: 12 months
Number of participants with >0.2mm of marginal bone levels
Time frame: 12 months
Band of keratinized tissue: clinical presence or absence
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2023.
Related trials for Tooth Loss
Recruiting
Effect of Collagen Membrane on Ridge Preservation
Dehiscence, Tooth Extraction
Not yet recruiting
The Effect of Bitewing Radiography on Outcomes and Costs of Treating Caries in Permanent Teeth
Dental Caries, Teeth Loss
Not yet recruiting
Immediate vs Conventional Loading With Different Crown Materials on Immediately Placed Single Implants
Partial Edentulism, Dental Implant
Recruiting
One vs Two Visits Root Canal Treatments in Infected Teeth
Apical Periodontitis, Pain
Active, not recruiting
3D-Printed Versus Band-and-Loop Versus Denovo Space Maintainers in Primary Dentition.
Space Maintenance, Tooth Loss / Rehabilitation
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.
Verdugo, PhD principal investigator
Verdugo, Fernando, DDS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing implant placement in people with Tooth Loss and Bone Loss, Alveolar, 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 6 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: status not confirmed, as of the sponsor's last update on 26 Apr 2023. 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?
Results are not available in the source record.
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?
Evaluate implant placement feasibility & success rate at 12 months (time frame: 12 months). The study lists 2 primary outcomes in all. 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 26 Apr 2023.