Missing Teeth2implantsNCT05359549
Dental Implant Treatment for Two Adjacent Teeth in the Maxillary Aesthetic Region: an Evaluation After 10 Years
An observational study of Missing Teeth, run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
Background Replacement of two missing adjacent teeth is considered a difficult treatment in implant dentistry and even more challenging if located in the anterior region due to aesthetic demands. As well peri-implant bone contour as soft tissue volume is compromised at start of the treatment and difficult to restore. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Missing Teeth
- What is being tested?
- Two endosseous dental implants (NobelReplace Groovy®) were placed 10 years ago
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 25 participants
- Where
- 1 siteNetherlands
- Study dates
- 6 Oct 2022to 1 May 2023
- How long will I take part?
- 10 Years
- Phase
- Observational
- 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
- Adult, Older adult
Study population: All patients were 10 years ago referred to the Department of Oral and Maxillofacial Surgery (University of Groningen, University Medical Hospital) because of having two failing teeth in the maxillary aesthetic region and were treated with dental implant placement and implant-supported restorations.
Who may be able to join
- Patients, having two missing teeth in the maxillary aesthetic region, referred to the department of Oral and Maxillofacial Surgery 10 years ago and treated with dental implant placement and implant-supported restorations. At the time of treatment:
- The patient was 18 years or older;
- The failing teeth were an incisor (central or lateral), cuspid or first bicuspid in the maxilla; the adjacent teeth are natural teeth;
- Sufficient healthy and vital bone to insert a dental implant with a minimum length of 10 mm and at least 3.5 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.
Netherlands1 site
Dept Oral and Maxillofacial Surgery UMCG
Groningen, Provincie Groningen, 9713GZ
About this study
- Background Replacement of two missing adjacent teeth is considered a difficult treatment in implant dentistry and even more challenging if located in the anterior region due to aesthetic demands. As well peri-implant bone contour as soft tissue volume is compromised at start of the treatment and difficult to restore. The question is if this reconstruction will be stable in the longterm. Full-scale evaluation of adjacent implant placement with crown rehabilitation in the aesthetic region with a follow-up of at least 10 years is underreported in this field of implant dentistry.
- Main research question The aim of this observational study was to analyze peri-implant bone changes, mucosa levels, aesthetic ratings and patient-reported satisfaction with the maxillary aesthetic region following implant placement with crown restoration after a 10-years follow-up period.
- Design (including population, confounders/outcomes) The study design is an observational study of a group of patients with two missing adjacent teeth in the maxillary aesthetic region which was treated 10 years ago with dental implant placement and an implant-supported restorations.
Outcomes: primary outcome is the change in marginal peri-implant bone level 10 years after placing the definitive restoration. Secondary outcome measures will be implant and restoration survival and changes in interproximal peri-implant mucosa, midfacial peri-implant mucosal level , aesthetic outcome assessed by means of an objective index and patients' satisfaction using a questionnaire.
- Expected results Stable peri-implant bone levels, stable peri-implant soft tissue levels, high implant and restoration survival rate and satisfied patients.
Read the detailed description
The study design is an observational study of a group of 25 patients with two missing adjacent teeth in the maxillary aesthetic region which was treated 10 years ago with dental implant placement and an implant-supported restorations.
- Inclusion criteria:
- Patients, having two missing teeth in the maxillary aesthetic region, referred to the department of Oral and Maxillofacial Surgery 10 years ago and treated with dental implant placement and implant-supported restorations. At the time of treatment:
- The patient was 18 years or older;
- The failing teeth were an incisor (central or lateral), cuspid or first bicuspid in the maxilla; the adjacent teeth are natural teeth;
- Sufficient healthy and vital bone to insert a dental implant with a minimum length of 10 mm and at least 3.5 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.
- Exclusion criteria at the time of treatment:
- 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. All patients were 10 years ago referred to the Department of Oral and Maxillofacial Surgery (University of Groningen, University Medical Hospital) because of having two failing teeth in the maxillary aesthetic region and were treated with dental implant placement and implant-supported restorations. Patients will have a regular routine control visit (as part of regular follow-up of these patients). All data to be collected are part of the routine visit and collected regularly at earlier routine visits, except for the questionnaire. The questionnaire contains a limited number of questions with respect to satisfaction with the aesthetic result. If patients are willing to participate (to use their research data and to fill in the questionnaire), they will be asked to give informed consent by signing a form. After signing, they will be included in the 10-years evaluation as participant. The forms will be collected in the CRF and in the medical record it will be noted that patient has signed the informed consent. Data will be collected during the routine control visit; patients will not have an extra visit for data collection.
- Conditions
- Missing Teeth
- Being tested
- Two endosseous dental implants (NobelReplace Groovy®) were placed 10 years ago
- Keywords
- dental implants
- Medical subject headings
- Anodontia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Two endosseous dental implants (NobelReplace Groovy®) were placed 10 years agoDevice
All patients were 10 years ago referred to the Department of Oral and Maxillofacial Surgery (University of Groningen, University Medical Hospital) because of having two failing teeth in the maxillary aesthetic region and were treated with dental implant placement and implant-supported restorations. Patients will have a regular routine control visit (as part of regular follow-up of these patients)
| Study group | Role | What they receive |
|---|---|---|
| Two adjacent dental implants | 25 patients with two missing adjacent teeth in the maxillary aesthetic region which was treated 10 years ago with dental implant placement and an implant-supported restorations. Receives: Device: Two endosseous dental implants (NobelReplace Groovy®) were placed 10 years ago |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in peri-implant marginal bone level
Change in peri-implant marginal bone level along the implant side measured on radiographs in millimetres
Measured: Comparison initial radiograph with radiograph after 10 years
Secondary outcomes (4)
Implant survival
Percentage of initially placed of dental implants present after 10 years
Measured: 10 years
Restoration survival
Survival of implant restorations after 10 years
Measured: 10 years
Peri-implant soft tissue health
Health of peri-implant soft tissues after 10 years measured with an ordinal index
Measured: Status at 10 years
Patient satisfaction
Satisfaction of patients measured with an VAS scale in questionnaire
Measured: Satisfaction at 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2022
- Study start6 Oct 2022
- Primary completion1 May 2023
- Study completion1 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Missing TeethStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Henny JA Meijer, Prof, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05359549
- Sponsor's protocol ID
- 202200150
- Acronym
- 2implants
- Status last verified
- Oct 2023
- First submitted
- 29 Mar 2022
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Upon reasonable request
Publications
Tymstra N, Raghoebar GM, Vissink A, Den Hartog L, Stellingsma K, Meijer HJ. Treatment outcome of two adjacent implant crowns with different implant platform designs in the aesthetic zone: a 1-year randomized clinical trial. J Clin Periodontol. 2011 Jan;38(1):74-85. doi: 10.1111/j.1600-051X.2010.01638.x. Epub 2010 Nov 10.
PubMed 21062337Van Nimwegen WG, Raghoebar GM, Stellingsma K, Tymstra N, Vissink A, Meijer HJ. Treatment Outcome of Two Adjacent Implant-Supported Restorations with Different Implant Platform Designs in the Esthetic Region: A Five-Year Randomized Clinical Trial. Int J Prosthodont. 2015 Sep-Oct;28(5):490-8. doi: 10.11607/ijp.4199.
PubMed 26340009
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
- Dental Implant Treatment for Two Adjacent Teeth in the Maxillary Aesthetic Region: an Evaluation After 10 Years
- ClinicalTrials.gov ID
- NCT05359549
- Acronym / sponsor ID
- 2implants / 202200150
- Conditions
- Missing Teeth
- Keywords
- dental implants
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- 6 Oct 2022 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 4 May 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.
- Background Replacement of two missing adjacent teeth is considered a difficult treatment in implant dentistry and even more challenging if located in the anterior region due to aesthetic demands. As well peri-implant bone contour as soft tissue volume is compromised at start of the treatment and difficult to restore. The question is if this reconstruction will be stable in the longterm. Full-scale evaluation of adjacent implant placement with crown rehabilitation in the aesthetic region with a follow-up of at least 10 years is underreported in this field of implant dentistry.
- Main research question The aim of this observational study was to analyze peri-implant bone changes, mucosa levels, aesthetic ratings and patient-reported satisfaction with the maxillary aesthetic region following implant placement with crown restoration after a 10-years follow-up period.
- Design (including population, confounders/outcomes) The study design is an observational study of a group of patients with two missing adjacent teeth in the maxillary aesthetic region which was treated 10 years ago with dental implant placement and an implant-supported restorations.
Outcomes: primary outcome is the change in marginal peri-implant bone level 10 years after placing the definitive restoration. Secondary outcome measures will be implant and restoration survival and changes in interproximal peri-implant mucosa, midfacial peri-implant mucosal level , aesthetic outcome assessed by means of an objective index and patients' satisfaction using a questionnaire.
- Expected results Stable peri-implant bone levels, stable peri-implant soft tissue levels, high implant and restoration survival rate and satisfied patients.
Detailed description
The study design is an observational study of a group of 25 patients with two missing adjacent teeth in the maxillary aesthetic region which was treated 10 years ago with dental implant placement and an implant-supported restorations.
- Inclusion criteria:
- Patients, having two missing teeth in the maxillary aesthetic region, referred to the department of Oral and Maxillofacial Surgery 10 years ago and treated with dental implant placement and implant-supported restorations. At the time of treatment:
- The patient was 18 years or older;
- The failing teeth were an incisor (central or lateral), cuspid or first bicuspid in the maxilla; the adjacent teeth are natural teeth;
- Sufficient healthy and vital bone to insert a dental implant with a minimum length of 10 mm and at least 3.5 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.
- Exclusion criteria at the time of treatment:
- 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. All patients were 10 years ago referred to the Department of Oral and Maxillofacial Surgery (University of Groningen, University Medical Hospital) because of having two failing teeth in the maxillary aesthetic region and were treated with dental implant placement and implant-supported restorations. Patients will have a regular routine control visit (as part of regular follow-up of these patients). All data to be collected are part of the routine visit and collected regularly at earlier routine visits, except for the questionnaire. The questionnaire contains a limited number of questions with respect to satisfaction with the aesthetic result. If patients are willing to participate (to use their research data and to fill in the questionnaire), they will be asked to give informed consent by signing a form. After signing, they will be included in the 10-years evaluation as participant. The forms will be collected in the CRF and in the medical record it will be noted that patient has signed the informed consent. Data will be collected during the routine control visit; patients will not have an extra visit for data collection.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Two adjacent dental implants | – | Device: Two endosseous dental implants (NobelReplace Groovy®) were placed 10 years ago25 patients with two missing adjacent teeth in the maxillary aesthetic region which was treated 10 years ago with dental implant placement and an implant-supported restorations. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All patients were 10 years ago referred to the Department of Oral and Maxillofacial Surgery (University of Groningen, University Medical Hospital) because of having two failing teeth in the maxillary aesthetic region and were treated with dental implant placement and implant-supported restorations.
Key inclusion criteria (8 listed)
- Patients, having two missing teeth in the maxillary aesthetic region, referred to the department of Oral and Maxillofacial Surgery 10 years ago and treated with dental implant placement and implant-supported restorations. At the time of treatment:
Key exclusion criteria (5 listed)
- • Medical and general contraindications for the surgical procedures;
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 |
|---|---|---|
| Two endosseous dental implants (NobelReplace Groovy®) were placed 10 years agoAll patients were 10 years ago referred to the Department of Oral and Maxillofacial Surgery (University of Groningen, University Medical Hospital) because of having two failing teeth in the maxillary aesthetic region and were treated with dental implant placement and implant-supported restorations. Patients will have a regular routine control visit (as part of regular follow-up of these patients) | Device | Two adjacent dental implants |
Primary outcome
Change in peri-implant marginal bone level
Time frame: Comparison initial radiograph with radiograph after 10 years
Change in peri-implant marginal bone level along the implant side measured on radiographs in millimetres
4 secondary outcomes
Implant survival
Time frame: 10 years
Restoration survival
Time frame: 10 years
Peri-implant soft tissue health
Time frame: Status at 10 years
Patient satisfaction
Time frame: Satisfaction at 10 years
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 30 Mar 2025.
- Results publication: PubMed 21062337Tymstra N, Raghoebar GM, Vissink A, Den Hartog L, Stellingsma K, Meijer HJ. Treatment outcome of two adjacent implant crowns with different implant platform designs in the aesthetic zone: a 1-year randomized clinical trial. J Clin Periodontol. 2011 Jan;38(1):74-85. doi: 10.1111/j.1600-051X.2010.01638.x. Epub 2010 Nov 10.
- Results publication: PubMed 26340009Van Nimwegen WG, Raghoebar GM, Stellingsma K, Tymstra N, Vissink A, Meijer HJ. Treatment Outcome of Two Adjacent Implant-Supported Restorations with Different Implant Platform Designs in the Esthetic Region: A Five-Year Randomized Clinical Trial. Int J Prosthodont. 2015 Sep-Oct;28(5):490-8. doi: 10.11607/ijp.4199.
- Individual participant dataSharing planned: Undecided. Upon reasonable request
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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.
Henny JA Meijer, Prof 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 Missing Teeth, 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: finished, 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?
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?
Change in peri-implant marginal bone level (time frame: Comparison initial radiograph with radiograph after 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05359549, which also lists 2 linked publications.
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.