Dental Implant FailedNCT06059105
Immediate Implant Using an Inverted Co-Axis at 12º Versus a Conventional Conical Implant
A study testing Immediate Implant Surgery in people with Dental Implant Failed, run by Universitat Internacional de Catalunya at 1 site in Spain.
Trial summary
This study is a randomised controlled clinical trial. The patients will be included for the placement of immediate implants with immediate crown placement, to replace maxillary anterior teeth. Any significant differences between the Co-Axis implant and a conventional conical implant will be evaluated. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Implant Failed
- What is being tested?
- Immediate Implant Surgery
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 15 Mar 2022to 15 Sep 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients who presented with a good well-being status and no contraindication for undergoing an oral surgical procedure
- Patients aged 18 and over
- Adequate oral hygiene, with patient's presenting a plaque index lower than 15% using the Index Scale publish by Löe et al.
- Patients who demonstrated motivation and compiled by attending the allocated follow-up appointments
- One single tooth indicated to be extracted due to having a poor prognosis in the maxilla (central or lateral incisors, canines or premolars)
- Absence of vestibular dehiscence in the bone table and presence of soft tissue without recession (Alveolus type I according to the classification of Elian et al. which could be determined on the day of surgery
- Sufficient bone to allow implant placement with primary stability
- To avoid image blurring or artefacts during CBCT, patients were included if they did not have a bridge or amalgam restoration close to the implant placement.
Who cannot join
- If the patient presented with an acute infection in the tooth where the implant is to be placed
- Absence of posterior sector in which it would cause an occlusal overload
- Alveolus with enough space to place an implant with a diameter of 4.5mm (since implants with a 3.5 coronal diameter have a widening in the middle third of the implant of 4.5mm)
- Patients with an unstable periodontal status
- Patients who smoked more than 10 cigarettes a day
- Patients who had medical histories which contraindicate implant surgery.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Universitat Internacional de Catalunya
Sant Cugat del Vallès, Barcelona, 08195
Andrea Galve, +34659051487, andreagalve@UIC.es
Javier Gamon, +34627321249, jgamon@uic.es
About this study
Official title: Immediate Implant Using an Inverted Co-Axis at 12º Versus a Conventional Conical Implant: A Randomised Clinical Trial With 1 Year Follow-up
This study is a randomised controlled clinical trial. The patients will be included for the placement of immediate implants with immediate crown placement, to replace maxillary anterior teeth. Any significant differences between the Co-Axis implant and a conventional conical implant will be evaluated.
Read the detailed description
Introduction: It is commonly known that the placement of an immediate implant is a technique-sensitive procedure, as the implant should be placed in the palatal aspect for the perfect prosthetic emergence and profile. In order to supply this complexity, there is a novel macroimplant design involving an implant with a 12º angled platform. This angulation of the coronal part of the implant allows perfect emergence of the placement of post-extraction implants, since it is placed at the center of the socket, acquiring the best possible bone. In addition, thanks to the angled neck, prosthetic emergence is ideal, as it is corrected and emerges through the cingulate area, thus securing a perfect emergence profile.
Objectives:
Primary Outcomes: Evaluate the percentage of success and survival of the Inverted Co-Axis 12º Southern Implants versus the Internal Conical (Deep Tapered Conical) South Implants on a 1-2-1 follow-up.
Secondary Outcomes:
- To evaluate the primary stability of both implant systems through a coefficient stability if implants using the Penguin RFA;
- To evaluate the horizontal and vertical marginal bone loss via a CBCT, 1 year after implant placement;
- To evaluate the soft tissues via the Pink Esthetic Score (PES) 1 year post-op.
Materials and Methods: Patients were randomly assigned in 2 groups of 15 patients, conical or inverta co-axis implants. Immediate implants in the aesthetic zone of the superior maxilar were placed with an immediate provisional crown restoration. In the same surgery, a connective tissue graft was performed. Only type I sockets according to the Elian Classification were eligible for this study.
- Conditions
- Dental Implant Failed
- Being tested
- Immediate Implant Surgery
- Keywords
- co-axis implant, dental implant, implant angulation, success rate, marginal bone loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate Implant SurgeryDevice
Inverted Co-Axis 12º Southern Implants
Immediate Implant SurgeryDevice
Internal Conical (Deep Tapered Conical) South Implants
| Study group | Role | What they receive |
|---|---|---|
| Test Group | Experimental | Inverted Co-Axis 12º Southern Implants (15 patients): The implant is placed in the center of the socket due to that has an angled neck of 12º, which allows the implant to be placed in the center of the alveolus, optimizing the alveolar bone and improving the prosthetic emergence. This is due to the access of the screw being located palatally, simplifying the restoration of the crown, avoiding cemented crowns, lowering the laboratory cost and of prosthetic accessories. Receives: Device: Immediate Implant Surgery |
| Control Group | Active comparator | Internal Conical (Deep Tapered Conical) South Implants (15 patients): conventional conical implant with internal connection. The implant is placed palatally in order to have a good emergence profile. Receives: Device: Immediate Implant Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success Rate
ICOI Pisa Implant quality of Health Criteria
Measured: 1 year
Survival Rate
"the implant is still in mouth",
Measured: 1 year
Secondary outcomes (3)
Horizontal and Vertical bone Changes
Three CBCT will be made (CBCT 1- before implant placement, CBCT 2- just after implant placement, CBCT 3- 1 year before implant placement). First year bone loss overlap CBCT 1, 2 and 3. The horizontal bone changes will be from the implant platform at 1, 3 and 5mm from it. The vertical measurements will be from implant platform till the most vestibular and palatal bone peak.
Measured: 1 year
Implant primary stability
Recorded using Penguin RFA device
Measured: Right after the implant placement
Status of the soft tissues
The Pink Esthetic Score (PES) is based on seven variables: mesial papilla, distal papilla, soft tissue contour, gingival margin level, alveolar process deficiency, soft tissue colour and texture. Each variable will be evaluated with a score of 2-1-0, with 2 being the best score and 0 the worst score. The maximum score, which reflects a perfect coincidence of the peri-implant soft tissue with that of the reference tooth, is 14.
Measured: At 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start15 Mar 2022
- Primary completion15 Sep 2024 (estimated)
- Study completion15 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Implant FailedStudies 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
- Model description
- The patients will be randomized into two groups. The test group (n=15) will be treated with the Inverta Co-Axis 12º implant (Southern Implants). In the control group (n=15) the Internal Conical implants (Southern implants) will be used. The difference between both implants lies in the fact that the Inverta Co-Axis 12º implant presents two different variants to the classic implant with parallel walls (Internal Conical)
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitat Internacional de Catalunya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JAVIER GAMON, Universitat Internacional de Catalunya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06059105
- Sponsor's protocol ID
- CIR-ELC-2021-09
- Status last verified
- Sep 2023
- First submitted
- 4 Sep 2023
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Implant Using an Inverted Co-Axis at 12º Versus a Conventional Conical Implant: A Randomised Clinical Trial With 1 Year Follow-up
- ClinicalTrials.gov ID
- NCT06059105
- Acronym / sponsor ID
- CIR-ELC-2021-09
- Conditions
- Dental Implant Failed
- Keywords
- co-axis implant, dental implant, implant angulation, success rate, marginal bone loss
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Universitat Internacional de CatalunyaUniversity, hospital or other
- Study start
- 15 Mar 2022 (actual)
- Primary completion
- 15 Sep 2024 (estimated)
- Study completion
- 15 Sep 2024 (estimated)
- First posted
- 28 Sep 2023 (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.
This study is a randomised controlled clinical trial. The patients will be included for the placement of immediate implants with immediate crown placement, to replace maxillary anterior teeth. Any significant differences between the Co-Axis implant and a conventional conical implant will be evaluated.
Detailed description
Introduction: It is commonly known that the placement of an immediate implant is a technique-sensitive procedure, as the implant should be placed in the palatal aspect for the perfect prosthetic emergence and profile. In order to supply this complexity, there is a novel macroimplant design involving an implant with a 12º angled platform. This angulation of the coronal part of the implant allows perfect emergence of the placement of post-extraction implants, since it is placed at the center of the socket, acquiring the best possible bone. In addition, thanks to the angled neck, prosthetic emergence is ideal, as it is corrected and emerges through the cingulate area, thus securing a perfect emergence profile.
Objectives:
Primary Outcomes: Evaluate the percentage of success and survival of the Inverted Co-Axis 12º Southern Implants versus the Internal Conical (Deep Tapered Conical) South Implants on a 1-2-1 follow-up.
Secondary Outcomes:
- To evaluate the primary stability of both implant systems through a coefficient stability if implants using the Penguin RFA;
- To evaluate the horizontal and vertical marginal bone loss via a CBCT, 1 year after implant placement;
- To evaluate the soft tissues via the Pink Esthetic Score (PES) 1 year post-op.
Materials and Methods: Patients were randomly assigned in 2 groups of 15 patients, conical or inverta co-axis implants. Immediate implants in the aesthetic zone of the superior maxilar were placed with an immediate provisional crown restoration. In the same surgery, a connective tissue graft was performed. Only type I sockets according to the Elian Classification were eligible for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The patients will be randomized into two groups. The test group (n=15) will be treated with the Inverta Co-Axis 12º implant (Southern Implants). In the control group (n=15) the Internal Conical implants (Southern implants) will be used. The difference between both implants lies in the fact that the Inverta Co-Axis 12º implant presents two different variants to the classic implant with parallel walls (Internal Conical)
| Arm | Type | Receives |
|---|---|---|
| Test Group | Experimental | Device: Immediate Implant SurgeryInverted Co-Axis 12º Southern Implants (15 patients): The implant is placed in the center of the socket due to that has an angled neck of 12º, which allows the implant to be placed in the center of the alveolus, optimizing the alveolar bone and improving the prosthetic emergence. This is due to the access of the screw being located palatally, simplifying the restoration of the crown, avoiding cemented crowns, lowering the laboratory cost and of prosthetic accessories. |
| Control Group | Active comparator | Device: Immediate Implant SurgeryInternal Conical (Deep Tapered Conical) South Implants (15 patients): conventional conical implant with internal connection. The implant is placed palatally in order to have a good emergence profile. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients who presented with a good well-being status and no contraindication for undergoing an oral surgical procedure
- Patients aged 18 and over
- Adequate oral hygiene, with patient's presenting a plaque index lower than 15% using the Index Scale publish by Löe et al.
- Patients who demonstrated motivation and compiled by attending the allocated follow-up appointments
- One single tooth indicated to be extracted due to having a poor prognosis in the maxilla (central or lateral incisors, canines or premolars)
Key exclusion criteria (6 listed)
- If the patient presented with an acute infection in the tooth where the implant is to be placed
- Absence of posterior sector in which it would cause an occlusal overload
- Alveolus with enough space to place an implant with a diameter of 4.5mm (since implants with a 3.5 coronal diameter have a widening in the middle third of the implant of 4.5mm)
- Patients with an unstable periodontal status
- Patients who smoked more than 10 cigarettes a day
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 |
|---|---|---|
| Immediate Implant SurgeryInverted Co-Axis 12º Southern Implants | Device | Test Group |
| Immediate Implant SurgeryInternal Conical (Deep Tapered Conical) South Implants | Device | Control Group |
Primary outcome
Success Rate
Time frame: 1 year
ICOI Pisa Implant quality of Health Criteria
Survival Rate
Time frame: 1 year
"the implant is still in mouth",
3 secondary outcomes
Horizontal and Vertical bone Changes
Time frame: 1 year
Implant primary stability
Time frame: Right after the implant placement
Status of the soft tissues
Time frame: At 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immediate Implant Surgery in people with Dental Implant Failed, run by Universitat Internacional de Catalunya 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 8 inclusion and 6 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 28 Sep 2023. 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?
Contact Andrea Galve (+34659051487, andreagalve@UIC.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success Rate (time frame: 1 year). The study lists 2 primary outcomes in all. 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 28 Sep 2023; AzTrials last refreshed its copy on 26 Oct 2026.