Bone LossNCT05301400
Marginal Bone Loss in Single Implant Restaurations With Different Methods
A study testing Bti Unit in people with Bone Loss, run by Universidad de León at 1 site in Spain.
Trial summary
The investigator is going to measure the marginal bone loss in single implant restaurations with three different methods: direct overcast, milled cad/cam direct to implant restauration and milled cad/cam implant restauration using an transepithelial pilar Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Bone Loss
- What is being tested?
- Bti Unit
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2022to 30 Mar 2025
- 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 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients with single implants restaurations treated in Leon University
Who cannot join
- pregnant
- mayor heath issues
- patients who do not agree to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Marginal Bone Loss in Single Implant Restaurations With Three Different Methods
The investigator is going to measure the marginal bone loss in single implant restaurations with three different methods: direct overcast, milled cad/cam direct to implant restauration and milled cad/cam implant restauration using an transepithelial pilar
Read the detailed description
The investigator has chosen a statistically significant sample (compared with other similar studies) to analize the bone marginal loss in different types of restauration with single dental implants
- Conditions
- Bone Loss
- Being tested
- Bti Unit
- Medical subject headings
- Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bti UnitDevice
Comparison with or without the device
| Study group | Role | What they receive |
|---|---|---|
| Overcast implant single restauration | Active comparator | Not described Receives: Device: Bti Unit |
| Cad/cam direct implant restauration | Active comparator | Not described Receives: Device: Bti Unit |
| Cad/cam implant restauration with transepithelial pilar | Active comparator | Not described Receives: Device: Bti Unit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of marginal loss in single dental implants
To evaluate the vertical loss of bone in milimiters around the implant
Measured: 6 months
Secondary outcomes (1)
Number of Implants with Prosthetic complications
The investigator is going to analyze if there is porcelain chipping (yes or not) and screw loosening (yes or not)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2022
- Study start1 Sep 2022
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 59 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de León
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patricia Truchuelo, Universidad de León
- Investigators
- Jesus Seco, Study director, Universidad de León
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05301400
- Sponsor's protocol ID
- ULeon
- Status last verified
- Feb 2024
- First submitted
- 26 Feb 2022
- Last updated
- 9 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Bone marginal loss
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Marginal Bone Loss in Single Implant Restaurations With Three Different Methods
- ClinicalTrials.gov ID
- NCT05301400
- Acronym / sponsor ID
- ULeon
- Conditions
- Bone Loss
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 59 participants (estimated)
- Lead sponsor
- Universidad de LeónUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Mar 2025 (estimated)
- First posted
- 29 Mar 2022 (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.
The investigator is going to measure the marginal bone loss in single implant restaurations with three different methods: direct overcast, milled cad/cam direct to implant restauration and milled cad/cam implant restauration using an transepithelial pilar
Detailed description
The investigator has chosen a statistically significant sample (compared with other similar studies) to analize the bone marginal loss in different types of restauration with single dental implants
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Overcast implant single restauration | Active comparator | Device: Bti Unit |
| Cad/cam direct implant restauration | Active comparator | Device: Bti Unit |
| Cad/cam implant restauration with transepithelial pilar | Active comparator | Device: Bti Unit |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with single implants restaurations treated in Leon University
Key exclusion criteria (3 listed)
- pregnant
- mayor heath issues
- patients who do not agree to participate
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 |
|---|---|---|
| Bti UnitComparison with or without the device | Device | Cad/cam direct implant restauration, Cad/cam implant restauration with transepithelial pilar, Overcast implant single restauration |
Primary outcome
Rate of marginal loss in single dental implants
Time frame: 6 months
To evaluate the vertical loss of bone in milimiters around the implant
1 secondary outcome
Number of Implants with Prosthetic complications
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2024.
- Individual participant dataSharing planned: Yes. Bone marginal loss
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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.
Jesus Seco study director
Universidad de León
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bti Unit in people with Bone Loss, run by Universidad de León at 1 site in Spain.
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 1 inclusion and 3 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 9 Feb 2024. 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 Spain. 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?
Rate of marginal loss in single dental implants (time frame: 6 months). 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 9 Feb 2024.