Edentulous Alveolar RidgeNCT04006782
Narrow Dental Implants in Multiple Fixed Prosthesis: A Controlled Clinical Trial
A study testing Narrow dental implants in people with Edentulous Alveolar Ridge, run by Fundación Eduardo Anitua at 1 site in Spain.
Trial summary
The objective of this study is to evaluate the survival of narrow dental implants (≤ 3,5 mm) in multiple fixed prostheses in comparison with standard diameter dental implants (≥ 3,75 mm) after 5 years of follow-up. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Edentulous Alveolar Ridge
- What is being tested?
- Narrow dental implants
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteSpain
- Study dates
- 1 Aug 2019to 31 Jan 2026
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients of legal age (>18 years) of both sexes.
- Clinical need of multiple fixed alveolar ridge rehabilitations.
- Clinical suitability to insert, at least, one narrow dental implant splinted to a standard diameter dental implant.
- Signature of the informed consent
Who cannot join
- Presence of an active infection
- Being under active treatment with, or have received in the las 30 days treatment with radiotherapy, chemotherapy, immunosuppressors, systemic corticosteroids and/or anticoagulants.
- Presence of severe haematologic disorders.
- Chronic treatment with non steroidal anti-inflammatory drugs (NSAID) or other aniinflammatory drugs.
- Previous diagnosis of chronic hepatitis or liver cirrhosis.
- Presence of Diabetes mellitus with improper metabolic control (glycosylated haemoglobine higher that 9%).
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- Patients subjected to dialysis.
- Presence of malignant tumours, haemangioma or angioma in the surgical area.
- History of ischaemic cardiopathy in the las year.
- Pregnancy or plan to getting pregnant during the study.
- Metabolic bone disease
- Patientd receiving treatment with oral or intravenous biphosphonates.
- Any other condition incompatible with the participation in the study,
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Narrow Dental Implants in Multiple Fixed Prosthesis
The objective of this study is to evaluate the survival of narrow dental implants (≤ 3,5 mm) in multiple fixed prostheses in comparison with standard diameter dental implants (≥ 3,75 mm) after 5 years of follow-up. The hypothesis of the study is that narrow dental implants under the evaluated conditions, have the same survival rate and clinical performance than the standard diameter implants.
- Conditions
- Edentulous Alveolar Ridge
- Being tested
- Narrow dental implants
- Keywords
- edentulous, narrow alveolar ridges
- Medical subject headings
- Mouth, Edentulous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Narrow dental implantsDevice
Insertion of narrow dental implants in multiple fixed prosthesis
| Study group | Role | What they receive |
|---|---|---|
| Narrow dental implants in multiple fixed prosthesis | Other | Not described Receives: Device: Narrow dental implants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival after 5 years of follow-up
Implant survival after 5 years of follow-up
Measured: 5 years in comparison with the baseline
Secondary outcomes (1)
Marginal Bone Loss
Evolution of the peri-implant bone level along the study follow up
Measured: 1, 3 and 5 years in comparison with the baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start1 Aug 2019
- Primary completion31 Jan 2026 (estimated)
- Study completion31 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Edentulous Alveolar RidgeStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 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
- NCT04006782
- Sponsor's protocol ID
- FIBEA_02_EC_19_Estrechos
- Status last verified
- Feb 2025
- First submitted
- 1 Jul 2019
- Last updated
- 27 Feb 2025
- 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 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Narrow Dental Implants in Multiple Fixed Prosthesis
- ClinicalTrials.gov ID
- NCT04006782
- Acronym / sponsor ID
- FIBEA_02_EC_19_Estrechos
- Conditions
- Edentulous Alveolar Ridge
- Keywords
- edentulous, narrow alveolar ridges
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Fundación Eduardo AnituaUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 31 Jan 2026 (estimated)
- Study completion
- 31 Jan 2026 (estimated)
- First posted
- 5 Jul 2019 (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 objective of this study is to evaluate the survival of narrow dental implants (≤ 3,5 mm) in multiple fixed prostheses in comparison with standard diameter dental implants (≥ 3,75 mm) after 5 years of follow-up. The hypothesis of the study is that narrow dental implants under the evaluated conditions, have the same survival rate and clinical performance than the standard diameter implants.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Narrow dental implants in multiple fixed prosthesis | Other | Device: Narrow dental implants |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients of legal age (>18 years) of both sexes.
- Clinical need of multiple fixed alveolar ridge rehabilitations.
- Clinical suitability to insert, at least, one narrow dental implant splinted to a standard diameter dental implant.
- Signature of the informed consent
Key exclusion criteria (13 listed)
- Presence of an active infection
- Being under active treatment with, or have received in the las 30 days treatment with radiotherapy, chemotherapy, immunosuppressors, systemic corticosteroids and/or anticoagulants.
- Presence of severe haematologic disorders.
- Chronic treatment with non steroidal anti-inflammatory drugs (NSAID) or other aniinflammatory drugs.
- Previous diagnosis of chronic hepatitis or liver cirrhosis.
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 |
|---|---|---|
| Narrow dental implantsInsertion of narrow dental implants in multiple fixed prosthesis | Device | Narrow dental implants in multiple fixed prosthesis |
Primary outcome
Survival after 5 years of follow-up
Time frame: 5 years in comparison with the baseline
Implant survival after 5 years of follow-up
1 secondary outcome
Marginal Bone Loss
Time frame: 1, 3 and 5 years in comparison with the baseline
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 27 Feb 2025.
- Individual participant dataSharing planned: No
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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 Narrow dental implants in people with Edentulous Alveolar Ridge, 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 4 inclusion and 13 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: under way, not looking for participants, as of the sponsor's last update on 27 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?
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?
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 after 5 years of follow-up (time frame: 5 years in comparison with the baseline). 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 27 Feb 2025.