Partial-edentulismNCT04929743
Randomized Clinical Trial to Evaluate the Predictability of 5.5 mm Dental Implants
A study testing BTI Implant in people with Partial-edentulism, run by Fundación Eduardo Anitua at 1 site in Spain.
Trial summary
The main aim of this clinical trial is to analyze the survival rate of short-length implants (<4.5 mm) in partial edentulism subjects. 6.5 mm length implants 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSpain
- Study dates
- 11 May 2021to 27 Nov 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Clinical indication to place a prosthetic bridge supported by a maximum of 4 implants in the posterior sectors
- Bone height in the area of interest sufficient to place implants 6.5mm length dental implants
- Availability to be observed during the follow-up period
- Signature of the informed consent
Who cannot join
- Need to perform bone augmentation surgery prior to implant placement surgery
- Smokers (> 10 cigarettes per day)
- Patients with poorly controlled diabetes
- Patients on chronic treatment with non-steroidal anti-inflammatory drugs
- Patients receiving oral or intravenous bisphosphonates
- Patients under chemotherapy or radiotherapy treatment
- Patients receiving systemic corticosteroids
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Clinical Trial to Evaluate the Predictability and Evolution of Extra-short 5.5 mm Dental Implants Splinted in Partial or Complete Prostheses
The main aim of this clinical trial is to analyze the survival rate of short-length implants (<4.5 mm) in partial edentulism subjects. 6.5 mm length implants 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
Placement of dental implants of 5.5 vs >6.5 mm length
| Study group | Role | What they receive |
|---|---|---|
| 5.5 mm implants | Experimental | Not described Receives: Device: BTI Implant |
| >6.5 mm implants | Active comparator | 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 implants
Survival of implants at one year post-implantation
Measured: 1 year
Secondary outcomes (4)
Marginal bone loss
Marginal bone loss at one year post-implantation
Measured: 1 year
Incidence of bleeding on probing
Measured: 1 year
Incidence of prosthetic or implant complications
Measured: 1 year
Probing pocket depth
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 posted18 Jun 2021
- Study start11 May 2021
- Primary completion27 Nov 2024
- Study completion27 Nov 2024
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación Eduardo Anitua
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04929743
- Sponsor's protocol ID
- BTI_02_EC/20/4.5
- Status last verified
- Feb 2025
- First submitted
- 9 Jun 2021
- Last updated
- 25 Feb 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 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial to Evaluate the Predictability and Evolution of Extra-short 5.5 mm Dental Implants Splinted in Partial or Complete Prostheses
- ClinicalTrials.gov ID
- NCT04929743
- Acronym / sponsor ID
- BTI_02_EC/20/4.5
- Conditions
- Partial-edentulism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Fundación Eduardo AnituaUniversity, hospital or other
- Study start
- 11 May 2021 (actual)
- Primary completion
- 27 Nov 2024 (actual)
- Study completion
- 27 Nov 2024 (actual)
- First posted
- 18 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 clinical trial is to analyze the survival rate of short-length implants (<4.5 mm) in partial edentulism subjects. 6.5 mm length implants will be used as control arm. Additionally, others clinical parameters (marginal bone loss and prosthetic associated complications) will be measured.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 5.5 mm implants | Experimental | Device: BTI Implant |
| >6.5 mm implants | Active comparator | Device: BTI Implant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years
- Clinical indication to place a prosthetic bridge supported by a maximum of 4 implants in the posterior sectors
- Bone height in the area of interest sufficient to place implants 6.5mm length dental implants
- Availability to be observed during the follow-up period
- Signature of the informed consent
Key exclusion criteria (7 listed)
- Need to perform bone augmentation surgery prior to implant placement surgery
- Smokers (> 10 cigarettes per day)
- Patients with poorly controlled diabetes
- Patients on chronic treatment with non-steroidal anti-inflammatory drugs
- Patients receiving oral or intravenous bisphosphonates
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 ImplantPlacement of dental implants of 5.5 vs >6.5 mm length | Device | 5.5 mm implants, >6.5 mm implants |
Primary outcome
Survival of implants
Time frame: 1 year
Survival of implants at one year post-implantation
4 secondary outcomes
Marginal bone loss
Time frame: 1 year
Incidence of bleeding on probing
Time frame: 1 year
Incidence of prosthetic or implant complications
Time frame: 1 year
Probing pocket depth
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 25 Feb 2025.
- Individual participant dataSharing planned: Undecided
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Immediate vs Conventional Loading With Different Crown Materials on Immediately Placed Single Implants
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Clinical Fit of Conventionally Cast and 0° SLM Removable Partial Denture Frameworks
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Survival of Implant-Supported All-Ceramic Prostheses
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Implant in people with 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 5 inclusion and 7 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 25 Feb 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?
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?
Survival of 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 25 Feb 2025.