Partial-edentulismNCT04927819
Extra-short vs. Non-extra-short Dental Implants Splinted on the Same Prosthesis
An observational study of Partial-edentulism, run by Fundación Eduardo Anitua at 1 site in Spain.
Trial summary
The main aim of this prospective study is to analyze the survival rate of short-length implants (<6.5 mm) in subjects with partial edentulism. Non-short length implant will be used as control arm. Additionally, others clinical parameters (marginal bone loss and prosthetic associated complications) will be measured. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Partial-edentulism
- What is being tested?
- BTI Implant
- Type of treatment
- Medical device
- How many people
- 102 participants
- Where
- 1 siteSpain
- Study dates
- 11 May 2021to 31 Jul 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Adult, Older adult
Study population: Partial edentulism
Who may be able to join
- Age ≥ 18 years
- Have planned a fixed multiple prosthesis supported by implants <6.5 mm in length and implants ≥ 6.5 mm in length within 15 days before the inclusion of the patient in the study.
- Planning of supported prostheses from 2 to 4 implants dental
- Have a previously performed CBCT (Cone Beam Computed Tomography)
- Availability to be observed during the period of tracing
- Signature of the informed consent
Who cannot join
- Smokers> 10 cigarettes / day
- Complete prostheses
- Unitary prostheses
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Clinica Eduardo Anitua
Vitoria-Gasteiz
Mikel Allende, +34945160653, mikel.allende@bti-implant.es
About this study
Official title: Prospective Observational Study on Evolution of Extra-short Implants (<6.5 mm) Compared to Non-extra-short Implants (≥ 6.5 mm) Splinted on the Same Prosthesis
The main aim of this prospective study is to analyze the survival rate of short-length implants (<6.5 mm) in subjects with partial edentulism. Non-short length implant will be used as control arm. Additionally, others clinical parameters (marginal bone loss and prosthetic associated complications) will be measured.
- Conditions
- Partial-edentulism
- Being tested
- BTI Implant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BTI ImplantDevice
BTI Dental implants are non-active medical device, single use, non resterilizable, biocompatible and sterile devices made of alloplastic materials (Titanium) intended to be surgically implanted into alveolar and/or basal bone of the mandible or maxilla to provide support and a means of retention for a dental prosthesis (e.g. bridge, single-tooth, overdenture).
| Study group | Role | What they receive |
|---|---|---|
| short-length implant (<6.5 mm) | Not described Receives: Device: BTI Implant | |
| non-short length implant (≥6.5 mm) | Not described Receives: Device: BTI Implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival of dental implants
Survival of dental implants at one year post-implantation
Measured: 1 year
Secondary outcomes (2)
Marginal bone loss
Marginal bone loss at one year post-implantation
Measured: 1 year
Incidence of prosthetic or implant complications
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 posted16 Jun 2021
- Study start11 May 2021
- Primary completion12 May 2022
- Study completion31 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Partial-edentulismStudies 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
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación Eduardo Anitua
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eduardo Anitua, MD, Principal investigator, Clinica Eduardo Anitua
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04927819
- Sponsor's protocol ID
- FIBEA_02_EP/20/Extracortos
- Status last verified
- Apr 2025
- First submitted
- 9 Jun 2021
- Last updated
- 17 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Study on Evolution of Extra-short Implants (<6.5 mm) Compared to Non-extra-short Implants (≥ 6.5 mm) Splinted on the Same Prosthesis
- ClinicalTrials.gov ID
- NCT04927819
- Acronym / sponsor ID
- FIBEA_02_EP/20/Extracortos
- Conditions
- Partial-edentulism
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Fundación Eduardo AnituaUniversity, hospital or other
- Study start
- 11 May 2021 (actual)
- Primary completion
- 12 May 2022 (actual)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 16 Jun 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.
The main aim of this prospective study is to analyze the survival rate of short-length implants (<6.5 mm) in subjects with partial edentulism. Non-short length implant will be used as control arm. Additionally, others clinical parameters (marginal bone loss and prosthetic associated complications) will be measured.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| short-length implant (<6.5 mm) | – | Device: BTI Implant |
| non-short length implant (≥6.5 mm) | – | Device: BTI Implant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Partial edentulism
Key inclusion criteria (6 listed)
- Age ≥ 18 years
- Have planned a fixed multiple prosthesis supported by implants <6.5 mm in length and implants ≥ 6.5 mm in length within 15 days before the inclusion of the patient in the study.
- Planning of supported prostheses from 2 to 4 implants dental
- Have a previously performed CBCT (Cone Beam Computed Tomography)
- Availability to be observed during the period of tracing
Key exclusion criteria (3 listed)
- Smokers> 10 cigarettes / day
- Complete prostheses
- Unitary prostheses
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 ImplantBTI Dental implants are non-active medical device, single use, non resterilizable, biocompatible and sterile devices made of alloplastic materials (Titanium) intended to be surgically implanted into alveolar and/or basal bone of the mandible or maxilla to provide support and a means of retention for a dental prosthesis (e.g. bridge, single-tooth, overdenture). | Device | non-short length implant (≥6.5 mm), short-length implant (<6.5 mm) |
Primary outcome
Survival of dental implants
Time frame: 1 year
Survival of dental implants at one year post-implantation
2 secondary outcomes
Marginal bone loss
Time frame: 1 year
Incidence of prosthetic or implant complications
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2025.
- Individual participant dataSharing planned: Undecided
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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.
Eduardo Anitua, MD principal investigator
Clinica Eduardo Anitua
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 Partial-edentulism, run by Fundación Eduardo Anitua 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 6 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: looking for participants now, as of the sponsor's last update on 17 Apr 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mikel Allende, PhD (+34945160653 ext. 257, mikel.allende@bti-implant.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival of dental implants (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 17 Apr 2025.