Missing TeethPerformanceNCT05650099
Peri-implant Health of Dental Implants in the Posterior 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 Adaptation of a dental implant and its restoration to the existing anatomy in the region of a missing tooth is presumed to be a reliable procedure. During the follow-up it appears that peri-implant bone level is stable, peri-implant soft tissues are healthy and patients are satisfied with the result. 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?
- One or two dental implants (Biomet3I dental implant system) were placed 10 years ago
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 126 participants
- Where
- 1 siteNetherlands
- Study dates
- 6 Oct 2022to 6 Oct 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: The study design is an observational study of a group of 126 patients which were treated 10 years ago with a dental implant and an implant-supported restoration because of a missing tooth in the posterior region.
Who may be able to join
- Patients referred to the department of Oral and Maxillofacial Surgery 10 years ago and treated with a dental implant and an implant-supported 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 8.5 mm and at least 4.0 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 Adaptation of a dental implant and its restoration to the existing anatomy in the region of a missing tooth is presumed to be a reliable procedure. During the follow-up it appears that peri-implant bone level is stable, peri-implant soft tissues are healthy and patients are satisfied with the result. However, the number of 10-years studies on implants in the posterior region of maxilla and mandible is limited and much more studies with longer follow-up periods are needed to confirm the positive outcomes.
- Main research question The primary objective of the study is marginal bone level changes by radiological assessments at 10-years follow-up. Secondary objectives are implant and restoration survival, condition of peri- implant mucosa and patients' satisfaction.
- Design The study design is an observational study of a group of patients which were treated 10 years ago with a dental implant and an implant-supported restoration because of a missing tooth in the posterior region. 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, peri-implant mucosa health 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 126 patients which were treated 10 years ago with a dental implant and an implant-supported restoration because of a missing tooth in the posterior region.
- Inclusion criteria:
- Patients referred to the department of Oral and Maxillofacial Surgery 10 years ago and treated with a dental implant and an implant-supported 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 8.5 mm and at least 4.0 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 a missing tooth in the posterior region and were treated with a dental implant. 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 function of the implant-supported restoration. 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
- One or two dental implants (Biomet3I dental implant system) 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.
One or two dental implants (Biomet3I dental implant system) 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 missing posterior teeth 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 |
|---|---|---|
| Implants in the posterior region | 126 patients with one or two missing tooth/teeth in the posterior region were treated 10 years ago with dental implant treatment and implant-supported restorations Receives: Device: One or two dental implants (Biomet3I dental implant system) 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 posted14 Dec 2022
- Study start6 Oct 2022
- Primary completion6 Oct 2023
- Study completion6 Oct 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
- 126 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, UMCG Groningen, Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05650099
- Sponsor's protocol ID
- 11103
- Acronym
- Performance
- Status last verified
- Oct 2023
- First submitted
- 6 Dec 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
Telleman G, Raghoebar GM, Vissink A, Meijer HJ. Impact of platform switching on inter-proximal bone levels around short implants in the posterior region; 1-year results from a randomized clinical trial. J Clin Periodontol. 2012 Jul;39(7):688-97. doi: 10.1111/j.1600-051X.2012.01887.x. Epub 2012 Apr 29.
PubMed 22540412Telleman G, Meijer HJ, Vissink A, Raghoebar GM. Short implants with a nanometer-sized CaP surface provided with either a platform-switched or platform-matched abutment connection in the posterior region: a randomized clinical trial. Clin Oral Implants Res. 2013 Dec;24(12):1316-24. doi: 10.1111/clr.12000. Epub 2012 Sep 10.
PubMed 22957911
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
- Peri-implant Health of Dental Implants in the Posterior Region; an Evaluation After 10 Years
- ClinicalTrials.gov ID
- NCT05650099
- Acronym / sponsor ID
- Performance / 11103
- Conditions
- Missing Teeth
- Keywords
- Dental implants
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- 6 Oct 2022 (actual)
- Primary completion
- 6 Oct 2023 (actual)
- Study completion
- 6 Oct 2023 (actual)
- First posted
- 14 Dec 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 Adaptation of a dental implant and its restoration to the existing anatomy in the region of a missing tooth is presumed to be a reliable procedure. During the follow-up it appears that peri-implant bone level is stable, peri-implant soft tissues are healthy and patients are satisfied with the result. However, the number of 10-years studies on implants in the posterior region of maxilla and mandible is limited and much more studies with longer follow-up periods are needed to confirm the positive outcomes.
- Main research question The primary objective of the study is marginal bone level changes by radiological assessments at 10-years follow-up. Secondary objectives are implant and restoration survival, condition of peri- implant mucosa and patients' satisfaction.
- Design The study design is an observational study of a group of patients which were treated 10 years ago with a dental implant and an implant-supported restoration because of a missing tooth in the posterior region. 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, peri-implant mucosa health 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 126 patients which were treated 10 years ago with a dental implant and an implant-supported restoration because of a missing tooth in the posterior region.
- Inclusion criteria:
- Patients referred to the department of Oral and Maxillofacial Surgery 10 years ago and treated with a dental implant and an implant-supported 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 8.5 mm and at least 4.0 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 a missing tooth in the posterior region and were treated with a dental implant. 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 function of the implant-supported restoration. 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 |
|---|---|---|
| Implants in the posterior region | – | Device: One or two dental implants (Biomet3I dental implant system) were placed 10 years ago126 patients with one or two missing tooth/teeth in the posterior region were treated 10 years ago with dental implant treatment and implant-supported restorations |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study design is an observational study of a group of 126 patients which were treated 10 years ago with a dental implant and an implant-supported restoration because of a missing tooth in the posterior region.
Key inclusion criteria (8 listed)
- Patients referred to the department of Oral and Maxillofacial Surgery 10 years ago and treated with a dental implant and an implant-supported 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 8.5 mm and at least 4.0 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 |
|---|---|---|
| One or two dental implants (Biomet3I dental implant system) 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 missing posterior teeth 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 | Implants in the posterior region |
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 22540412Telleman G, Raghoebar GM, Vissink A, Meijer HJ. Impact of platform switching on inter-proximal bone levels around short implants in the posterior region; 1-year results from a randomized clinical trial. J Clin Periodontol. 2012 Jul;39(7):688-97. doi: 10.1111/j.1600-051X.2012.01887.x. Epub 2012 Apr 29.
- Results publication: PubMed 22957911Telleman G, Meijer HJ, Vissink A, Raghoebar GM. Short implants with a nanometer-sized CaP surface provided with either a platform-switched or platform-matched abutment connection in the posterior region: a randomized clinical trial. Clin Oral Implants Res. 2013 Dec;24(12):1316-24. doi: 10.1111/clr.12000. Epub 2012 Sep 10.
- 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
UMCG Groningen, Netherlands
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 NCT05650099, 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.