Edentulous Alveolar RidgeNCT06110611
Monolithic Zirconia With CAD/CAM Titanium Abutments: A 5-year Prospective Case Series Study
An observational study of Edentulous Alveolar Ridge, run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
Background There is a growing interest in restoring function in the posterior maxilla and mandible with dental implants. Next to this, these implants must be restored with crowns which are subject to minimal complications. Companies have introduced the option of screw-retaining and zirconia as crown material. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Edentulous Alveolar Ridge
- What is being tested?
- Astra Tech Osseospeed EV® dental implant
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Oct 2024to 1 Jun 2026
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Study population: Patients referred to the department of Oral and Maxillofacial Surgery 5 years ago and treated with a dental implant and a screw-retained implant-supported zirconia restoration because of having a missing tooth in the posterior region. At the time of treatment: * The patient was 18 years or older; * The missing tooth was a premolar or molar in maxilla or mandible;
Who may be able to join
- Patients referred to the department of Oral and Maxillofacial Surgery 5 years ago and treated with a dental implant and a screw-retained implant-supported zirconia restoration because of having a missing tooth in the posterior region. At the time of treatment:
- The patient was 18 years or older;
- The missing tooth was a premolar or molar in maxilla or mandible;
- Sufficient healthy and vital bone to insert a dental implant with a minimum length of 8 mm and at least 4.2 mm in diameter with initial stability > 45 Ncm
- The implant site was free from infection;
- Adequate oral hygiene (modified plaque index and modified sulcus bleeding index ≤ 1);
- Sufficient mesio-distal, bucco-lingual, and interocclusal space for placement of an anatomic restoration;
- The patient was capable of understanding and giving informed consent.
Who cannot join
- Medical and general contraindications for the surgical procedures;
- Presence of an active and uncontrolled periodontal disease;
- Bruxism;
- Smoking
- A history of local radiotherapy to the head and neck region.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Monolithic Zirconia Single Tooth Implant-supported Restorations With CAD/CAM Titanium Abutments in the Posterior Region: A 5-year Prospective Case Series Study
- Background There is a growing interest in restoring function in the posterior maxilla and mandible with dental implants. Next to this, these implants must be restored with crowns which are subject to minimal complications. Companies have introduced the option of screw-retaining and zirconia as crown material. The combination of posterior implants and screw-retained zirconia crowns are widely used, but prospective research on clinical performance and patient centered outcomes are scarce. Even more, 5-years data are lacking.
- Main research question To evaluate the clinical performance of Astra Tech Implants EV and Atlantis CustomBase Abutments with full-contour zirconia Atlantis Crowns in the posterior maxilla and mandible. The primary objective of the study is marginal bone level changes by radiological assessments at 5-years follow-up. Secondary objectives are implant and restoration survival, condition of peri- implant mucosa and patients' satisfaction.
- Design (including population, confounders/outcomes) The study design is an observational study of a group of patients which were treated 5 years ago with a dental implant and a screw-retained implant-supported zirconia restoration because of a missing tooth in the posterior region. Outcomes: primary outcome is the change in marginal peri-implant bone level 5 years after placing the definitive restoration. Secondary outcome measures will be implant and restoration survival, peri-implant mucosa health and patients' satisfaction using a questionnaire.
Read the detailed description
- Introduction and rationale Nowadays, the use of dental implants for oral rehabilitation is a generally accepted treatment modality. During the first years of implant dentistry, dental implants were used mainly for the restoration of edentulous mandibles with implant-supported prostheses. Yet, there is a shift towards the application of dental implants for single-tooth replacements, supported by long-term studies reporting excellent survival rates. Not only in the aesthetic region, but also in the posterior maxilla and mandible there is a growing interest in restoring function. Dental implants show a good performance in the posterior region; in recent years attention has been shifted towards a better initial stability to reduce treatment time. Next to this, implants must be restored with crowns which are subject to minimal complications. Specially for the posterior region, companies have introduced the option of screw-retaining and zirconia as crown material, of which less technical complications are mentioned. The combination of posterior implants and screw-retained zirconia crowns are widely used, but prospective research on clinical performance and patient centered outcomes are scarce and 5-years results are lacking.
RESEARCH QUESTION To evaluate the clinical performance of Astra Tech Implants EV and Atlantis CustomBase Abutments with full-contour zirconia Atlantis Crowns in the posterior maxilla and mandible after a 5-years follow-up.
STUDY DESIGN The study design is an observational study of a group of 50 patients which were treated 5 years ago with a dental implant and a screw-retained implant-supported zirconia restoration because of a missing tooth in the posterior region.
- Conditions
- Edentulous Alveolar Ridge
- Being tested
- Astra Tech Osseospeed EV® dental implant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Astra Tech Osseospeed EV® dental implantDevice
Also called Atlantis™ CustomBase abutment with full-contour zirconia Atlantis® Crown
Prospective study of a group of 50 patients which were treated 5 years ago with a dental implant and a screw-retained implant-supported zirconia restoration because of a missing tooth in the posterior region.
| Study group | Role | What they receive |
|---|---|---|
| dental implant and a screw-retained implant-supported zirconia restoration | patients which were treated 5 years ago with a dental implant and a screw-retained implant-supported zirconia restoration Receives: Device: Astra Tech Osseospeed EV® dental implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in peri-implant marginal bone level (in millimetres)
Difference in peri-implant bone level measured in millimetres
Measured: 5 years
Secondary outcomes (1)
Implant survival and restoration survival (in percentage)
Percentage of initially placed implants and restorations still in place after 5 years
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2023
- Study start1 Oct 2024
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Jun 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.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, H.J.A. Meijer (Henny), University Medical Center Groningen
- Investigators
- Henny Meijer, prof dr, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06110611
- Sponsor's protocol ID
- 18223
- Status last verified
- Mar 2025
- First submitted
- 17 Oct 2023
- Last updated
- 30 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 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monolithic Zirconia Single Tooth Implant-supported Restorations With CAD/CAM Titanium Abutments in the Posterior Region: A 5-year Prospective Case Series Study
- ClinicalTrials.gov ID
- NCT06110611
- Acronym / sponsor ID
- 18223
- Conditions
- Edentulous Alveolar Ridge
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 31 Oct 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.
- Background There is a growing interest in restoring function in the posterior maxilla and mandible with dental implants. Next to this, these implants must be restored with crowns which are subject to minimal complications. Companies have introduced the option of screw-retaining and zirconia as crown material. The combination of posterior implants and screw-retained zirconia crowns are widely used, but prospective research on clinical performance and patient centered outcomes are scarce. Even more, 5-years data are lacking.
- Main research question To evaluate the clinical performance of Astra Tech Implants EV and Atlantis CustomBase Abutments with full-contour zirconia Atlantis Crowns in the posterior maxilla and mandible. The primary objective of the study is marginal bone level changes by radiological assessments at 5-years follow-up. Secondary objectives are implant and restoration survival, condition of peri- implant mucosa and patients' satisfaction.
- Design (including population, confounders/outcomes) The study design is an observational study of a group of patients which were treated 5 years ago with a dental implant and a screw-retained implant-supported zirconia restoration because of a missing tooth in the posterior region. Outcomes: primary outcome is the change in marginal peri-implant bone level 5 years after placing the definitive restoration. Secondary outcome measures will be implant and restoration survival, peri-implant mucosa health and patients' satisfaction using a questionnaire.
Detailed description
- Introduction and rationale Nowadays, the use of dental implants for oral rehabilitation is a generally accepted treatment modality. During the first years of implant dentistry, dental implants were used mainly for the restoration of edentulous mandibles with implant-supported prostheses. Yet, there is a shift towards the application of dental implants for single-tooth replacements, supported by long-term studies reporting excellent survival rates. Not only in the aesthetic region, but also in the posterior maxilla and mandible there is a growing interest in restoring function. Dental implants show a good performance in the posterior region; in recent years attention has been shifted towards a better initial stability to reduce treatment time. Next to this, implants must be restored with crowns which are subject to minimal complications. Specially for the posterior region, companies have introduced the option of screw-retaining and zirconia as crown material, of which less technical complications are mentioned. The combination of posterior implants and screw-retained zirconia crowns are widely used, but prospective research on clinical performance and patient centered outcomes are scarce and 5-years results are lacking.
RESEARCH QUESTION To evaluate the clinical performance of Astra Tech Implants EV and Atlantis CustomBase Abutments with full-contour zirconia Atlantis Crowns in the posterior maxilla and mandible after a 5-years follow-up.
STUDY DESIGN The study design is an observational study of a group of 50 patients which were treated 5 years ago with a dental implant and a screw-retained implant-supported zirconia restoration because of a missing tooth in the posterior region.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| dental implant and a screw-retained implant-supported zirconia restoration | – | Device: Astra Tech Osseospeed EV® dental implantpatients which were treated 5 years ago with a dental implant and a screw-retained implant-supported zirconia restoration |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study population: Patients referred to the department of Oral and Maxillofacial Surgery 5 years ago and treated with a dental implant and a screw-retained implant-supported zirconia restoration because of having a missing tooth in the posterior region. At the time of treatment: * The patient was 18 years or older; * The missing tooth was a premolar or molar in maxilla or mandible;
Key inclusion criteria (8 listed)
- Patients referred to the department of Oral and Maxillofacial Surgery 5 years ago and treated with a dental implant and a screw-retained implant-supported zirconia restoration because of having a missing tooth in the posterior region. At the time of treatment:
- The patient was 18 years or older;
- The missing tooth was a premolar or molar in maxilla or mandible;
- Sufficient healthy and vital bone to insert a dental implant with a minimum length of 8 mm and at least 4.2 mm in diameter with initial stability > 45 Ncm
- The implant site was free from infection;
Key exclusion criteria (5 listed)
- Medical and general contraindications for the surgical procedures;
- Presence of an active and uncontrolled periodontal disease;
- Bruxism;
- Smoking
- A history of local radiotherapy to the head and neck region.
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 |
|---|---|---|
| Astra Tech Osseospeed EV® dental implantAlso: Atlantis™ CustomBase abutment with full-contour zirconia Atlantis® CrownProspective study of a group of 50 patients which were treated 5 years ago with a dental implant and a screw-retained implant-supported zirconia restoration because of a missing tooth in the posterior region. | Device | dental implant and a screw-retained implant-supported zirconia restoration |
Primary outcome
Change in peri-implant marginal bone level (in millimetres)
Time frame: 5 years
Difference in peri-implant bone level measured in millimetres
1 secondary outcome
Implant survival and restoration survival (in percentage)
Time frame: 5 years
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 30 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.
Henny Meijer, prof dr principal investigator
University Medical Center Groningen
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 Edentulous Alveolar Ridge, run by University Medical Center Groningen at 1 site in Netherlands.
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 5 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: enrolling by invitation, as of the sponsor's last update on 30 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 1 site in Netherlands. 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?
Change in peri-implant marginal bone level (in millimetres) (time frame: 5 years). 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 30 Mar 2025.