Dental ImplantsIBERICANCT05223387
Tissue Level vs Bone Level Implants for Plural Restorations : a Multicentre Randomised Controlled Trial
A study testing Axiom TL REG and Axiom BL REG in people with Dental Implants and Edentulous, run by Anthogyr at 3 sites in 2 countries.
Trial summary
Anthogyr Axiom Tissue-Level implants and corresponding Multi-Unit abutments recently enriched the available product range for dental surgeons. This Post-Market Clinical Follow-Up study aims at confirming the safety and performance of these products. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Implants, Edentulous
- What is being tested?
- Axiom TL REG and Axiom BL REG
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 30 Mar 2022to 18 Jul 2027
- 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 must have voluntarily signed the Informed Consent Form before any study related procedures are performed, are willing and able to attend scheduled follow-up visits and agree that the pseudonymized data are collected and analyzed.
- Patients must be males or females who are a minimum of 18 years of age.
- Patients with a minimum of 4 weeks history of edentulism in the study area, in need of a multiple teeth replacement with dental implants
- Patients with complete soft tissue coverage of the socket at implant placement
Who cannot join
- Patients with inadequate bone volume and/or quality: Only minor and simultaneous bone augmentation procedures will be allowed where required for regeneration of minor defects. Insufficient bone volume and quality is defined as secondary exclusion criterion and the patient will be considered as screening failure.
- Uncontrolled systemic disease that would interfere with dental implant therapy (e.g. uncontrolled diabetes)
- Any contraindications for oral surgical procedures
- History of local irradiation therapy in the head / neck area
- Patients who are currently heavy smokers (defined >10 cigarettes per day or >1 cigar per day), or have ≥ 20 pack years who use chewing tobacco
- Medical conditions requiring chronic high dose steroid therapy or high dose anti-resorptive treatment
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- Subjects who have undergone administration of any investigational device within 30 days of enrolment in the study
- Conditions or circumstances, in the opinion of the investigator, which would prevent completion of study participation or interfere with analysis of study results, such as history of non-compliance or unreliability
- Cognitive impairment that would interfere with the ability to perform adequate oral hygiene (assessed by Ottawa 3DY scale)
- Patients with chronic pain
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Spain2 sites
Universidad International de Catalunya
Barcelona
Universidad de Santiago de Compostela
Santiago de Compostela
About this study
Anthogyr Axiom Tissue-Level implants and corresponding Multi-Unit abutments recently enriched the available product range for dental surgeons. This Post-Market Clinical Follow-Up study aims at confirming the safety and performance of these products. The comparison with similar Anthogyr Axiom Bone-level implants will provide additional information on the effect of platform-switching in bone level maintenance for single and two-piece design at the implant level.
Read the detailed description
This is a multicenter, comparative, prospective, randomized, controlled, post-market clinical follow-up (PMCF) study.
The total study duration for each patient should be 3 years. Anthogyr Axiom TL and BL REG and corresponding Multi-Unit abutments will be placed in healed bone crests in the mandible or maxilla for multiple teeth replacement, followed by a provisional prosthesis immediately loaded, if the patient needs a provisional.
In total 8 visits per patient are scheduled in this study
Implant and prosthesis survival, success, bone level changes, patient reported outcome, soft tissue assessment and adverse events (AEs) will be assessed.
The investigational devices are CE-(Conformité Européenne, meaning European Conformity) marked product.
3 centers will participate in Spain and Portugal.
The study and any amendments will be performed as far as possible according to International Organization for Standardization (ISO) 14155 and conform to the Declaration of Helsinki (last revision Fortaleza 2013) and local legal and regulatory requirements.
- Conditions
- Dental Implants, Edentulous
- Being tested
- Axiom TL REG, Axiom BL REG
- Keywords
- Anthogyr, dental, implant
- Medical subject headings
- Mouth, Edentulous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Axiom TL REGDevice
Also called Multi-Unit abutment
Anthogyr AXIOM TL Reg will be placed in healed bone crests in the mandible or maxilla for multiple teeth replacement, followed by a provisional prosthesis immediately loaded, if the patient needs a provisional.
In each case, the MU abutment will be placed immediately after implant placement.
Multi-Unit abutments are used to fix the prosthesis
Axiom BL REGDevice
Also called Multi-Unit abutment
Axiom BL Reg implants will be placed in healed bone crests in the mandible or maxilla for multiple teeth replacement, followed by a provisional prosthesis immediately loaded, if the patient needs a provisional.
In each case, the MU abutment will be placed immediately after implant placement.
Multi-Unit abutments are used to fix the prosthesis
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Experimental | Anthogyr Axiom TL REG and corresponding Multi-Unit abutments Receives: Device: Axiom TL REG |
| Control Group | Active comparator | Anthogyr Axiom BL REG and corresponding Multi-Unit abutment Receives: Device: Axiom BL REG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Marginal Bone Level Change
Change in crestal bone level measured by analysis of standardized peri-apical xrays [mm].
Measured: 6 months,12 months, and 3 years after loading
Secondary outcomes (3)
Implant survival
A surviving implant is an implant that is in place at the time of evaluation.
Measured: 6 months,12 months, and 3 years after loading
Prosthesis Survival
a surviving prosthesis is a prosthesis that is not broken at the time of evaluation.
Measured: 6 months,12 months, and 3 years after prosthesis placement
14 item Oral Health Impact Profile (OHIP-14)
he local language version of the OPHIP-14 is a self-reported questionnaire that measures dysfunction, discomfort and disability attributed to oral conditions. The questionnaire focuses on seven dimensions of impact: Functional limitation; Pain; Psychological discomfort; Physical disability; Psychological disability; Social disability; Handicap. The patients will be asked to respond according to frequency of impact on a 5-point Likert scale coded never (score 0), hardly ever (score 1), occasionally (score 2), fairly often (score 3) and very often (score 4).
Measured: screening visit, 6, 12 months and 3 years after loading
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2022
- Study start30 Mar 2022
- Primary completion18 Jul 2025 (estimated)
- Study completion18 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental ImplantsStudies 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anthogyr
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Juan Blanco Carrión, Pr.Dr., Principal investigator, Universidad de Santiago de Compostela
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05223387
- Sponsor's protocol ID
- C1902
- Acronym
- IBERICA
- Status last verified
- Mar 2025
- First submitted
- 21 Jan 2022
- Last updated
- 19 Mar 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 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tissue Level vs Bone Level Implants for Plural Restorations : a Multicentre Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT05223387
- Acronym / sponsor ID
- IBERICA / C1902
- Conditions
- Dental Implants, Edentulous
- Keywords
- Anthogyr, dental, implant
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (actual)
- Lead sponsor
- AnthogyrIndustry (pharma, biotech, devices)
- Study start
- 30 Mar 2022 (actual)
- Primary completion
- 18 Jul 2025 (estimated)
- Study completion
- 18 Jul 2027 (estimated)
- First posted
- 4 Feb 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.
Anthogyr Axiom Tissue-Level implants and corresponding Multi-Unit abutments recently enriched the available product range for dental surgeons. This Post-Market Clinical Follow-Up study aims at confirming the safety and performance of these products. The comparison with similar Anthogyr Axiom Bone-level implants will provide additional information on the effect of platform-switching in bone level maintenance for single and two-piece design at the implant level.
Detailed description
This is a multicenter, comparative, prospective, randomized, controlled, post-market clinical follow-up (PMCF) study.
The total study duration for each patient should be 3 years. Anthogyr Axiom TL and BL REG and corresponding Multi-Unit abutments will be placed in healed bone crests in the mandible or maxilla for multiple teeth replacement, followed by a provisional prosthesis immediately loaded, if the patient needs a provisional.
In total 8 visits per patient are scheduled in this study
Implant and prosthesis survival, success, bone level changes, patient reported outcome, soft tissue assessment and adverse events (AEs) will be assessed.
The investigational devices are CE-(Conformité Européenne, meaning European Conformity) marked product.
3 centers will participate in Spain and Portugal.
The study and any amendments will be performed as far as possible according to International Organization for Standardization (ISO) 14155 and conform to the Declaration of Helsinki (last revision Fortaleza 2013) and local legal and regulatory requirements.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Device: Axiom TL REGAnthogyr Axiom TL REG and corresponding Multi-Unit abutments |
| Control Group | Active comparator | Device: Axiom BL REGAnthogyr Axiom BL REG and corresponding Multi-Unit abutment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients must have voluntarily signed the Informed Consent Form before any study related procedures are performed, are willing and able to attend scheduled follow-up visits and agree that the pseudonymized data are collected and analyzed.
- Patients must be males or females who are a minimum of 18 years of age.
- Patients with a minimum of 4 weeks history of edentulism in the study area, in need of a multiple teeth replacement with dental implants
- Patients with complete soft tissue coverage of the socket at implant placement
Key exclusion criteria (10 listed)
- Patients with inadequate bone volume and/or quality: Only minor and simultaneous bone augmentation procedures will be allowed where required for regeneration of minor defects. Insufficient bone volume and quality is defined as secondary exclusion criterion and the patient will be considered as screening failure.
- Uncontrolled systemic disease that would interfere with dental implant therapy (e.g. uncontrolled diabetes)
- Any contraindications for oral surgical procedures
- History of local irradiation therapy in the head / neck area
- Patients who are currently heavy smokers (defined >10 cigarettes per day or >1 cigar per day), or have ≥ 20 pack years who use chewing tobacco
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 |
|---|---|---|
| Axiom TL REGAlso: Multi-Unit abutmentAnthogyr AXIOM TL Reg will be placed in healed bone crests in the mandible or maxilla for multiple teeth replacement, followed by a provisional prosthesis immediately loaded, if the patient needs a provisional. In each case, the MU abutment will be placed immediately after implant placement. Multi-Unit abutments are used to fix the prosthesis | Device | Study Group |
| Axiom BL REGAlso: Multi-Unit abutmentAxiom BL Reg implants will be placed in healed bone crests in the mandible or maxilla for multiple teeth replacement, followed by a provisional prosthesis immediately loaded, if the patient needs a provisional. In each case, the MU abutment will be placed immediately after implant placement. Multi-Unit abutments are used to fix the prosthesis | Device | Control Group |
Primary outcome
Marginal Bone Level Change
Time frame: 6 months,12 months, and 3 years after loading
Change in crestal bone level measured by analysis of standardized peri-apical xrays [mm].
3 secondary outcomes
Implant survival
Time frame: 6 months,12 months, and 3 years after loading
Prosthesis Survival
Time frame: 6 months,12 months, and 3 years after prosthesis placement
14 item Oral Health Impact Profile (OHIP-14)
Time frame: screening visit, 6, 12 months and 3 years after loading
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 19 Mar 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.
Juan Blanco Carrión, Pr.Dr. principal investigator
Universidad de Santiago de Compostela
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Axiom TL REG and Axiom BL REG in people with Dental Implants and Edentulous, run by Anthogyr at 3 sites in 2 countries.
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 10 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 19 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain, Portugal. 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?
Marginal Bone Level Change (time frame: 6 months,12 months, and 3 years after loading). 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 19 Mar 2025.