Dental Implant FailedNCT06500923
Narrow-diameter Implants Replacing Maxillary Lateral Incisors
An observational study of Dental Implant Failed, run by University of Bern at 1 site in Denmark.
Trial summary
To present the 5-year clinical, radiographic, and aesthetic outcomes in patients with congenitally missing lateral incisors (MLIs) rehabilitated with two narrow-diameter implants (NDIs). 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?
- Oral rehabilitation by means of implant-supported single unit crowns
- Type of treatment
- Pill or oral medicine
- How many people
- 100 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Aug 2016to 15 Jun 2024
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients affected by congenital missing with uni- or bilateral maxillary lateral incisors (i.e. 12 and/or 22)
Who may be able to join
- Patients affected by congenital missing with uni- or bilateral maxillary lateral incisors (i.e. 12 and/or 22)
- Patients with systemic health or controlled medical conditions
- Patients arrested skeletal growth as documented by two body height measurements at least one year apart not indicating continuous growth (Jensen, 2019)
- Written Informed Consent
Who cannot join
- Patients contraindications to implant therapy (Hwang \& Wang, 2006, 2007) including
- Heavy smoking: >20 cigarettes/day
- Poor oral hygiene
- Compromised compliance
- Periodontally compromised conditions
- Patients with MLI's with the canine situated in the MLI region
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Five Year Outcomes at Two Narrow-diameter Implants to Replace Congenital Missing Maxillary Lateral Incisors
To present the 5-year clinical, radiographic, and aesthetic outcomes in patients with congenitally missing lateral incisors (MLIs) rehabilitated with two narrow-diameter implants (NDIs).
- Conditions
- Dental Implant Failed
- Being tested
- Oral rehabilitation by means of implant-supported single unit crowns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral rehabilitation by means of implant-supported single unit crownsOther
Surgery: Implant placement; Prothetic rehabilitation: single unit crown
| Study group | Role | What they receive |
|---|---|---|
| Ø2.9mm (Test) | Test patients have received a 2.9 Ø dental implant Receives: Other: Oral rehabilitation by means of implant-supported single unit crowns | |
| Ø3.3mm (Control) | Control patients have received a 3.3 Ø dental implant Receives: Other: Oral rehabilitation by means of implant-supported single unit crowns |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peri-implant marginal bone level changes
Changes in mm at the 1-year follow-up visit
Measured: 1 year
Secondary outcomes (3)
Implant Survival rate (%)
Number of implants in situ over the number of placed implants
Measured: 1-3-5 year
Aesthetic outcomes
Evaluation of the aesthetic outcomes by means of a dedicated Index (Copenhagen Index Score CPI) (Score 1-4 / Score 1: best outcome; 4 : worst outcome)
Measured: 1-3-5 year
PROMs
OHIP - 49 Scale (Score 1-3) (Score 1: best outcome; 3 : worst outcome)
Measured: 1-3-5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2024
- Study start1 Aug 2016
- Primary completion31 Dec 2021
- Study completion15 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bern
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital, Denmark
- Responsible party
- Sponsor
- Investigators
- Simon Storgaard Jensen, Prof., Study chair, Copenhagen University Hospital, Copenhagen, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06500923
- Sponsor's protocol ID
- 2012-58-0004
- Status last verified
- Jul 2024
- First submitted
- 8 Jul 2024
- Last updated
- 15 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Roccuzzo A, Imber JC, Lempert J, Mancini L, Jensen SS. Five Year Clinical, Radiographic and Soft Tissue Profilometric Outcomes at Two Narrow-Diameter Implants to Replace Missing Maxillary Lateral Incisors. Clin Oral Implants Res. 2025 Nov;36(11):1412-1423. doi: 10.1111/clr.70010. Epub 2025 Jul 27.
PubMed 40717340
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Five Year Outcomes at Two Narrow-diameter Implants to Replace Congenital Missing Maxillary Lateral Incisors
- ClinicalTrials.gov ID
- NCT06500923
- Acronym / sponsor ID
- 2012-58-0004
- Conditions
- Dental Implant Failed
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of BernUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital, Denmark
- Study start
- 1 Aug 2016 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 15 Jun 2024 (actual)
- First posted
- 15 Jul 2024 (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.
To present the 5-year clinical, radiographic, and aesthetic outcomes in patients with congenitally missing lateral incisors (MLIs) rehabilitated with two narrow-diameter implants (NDIs).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ø2.9mm (Test) | – | Other: Oral rehabilitation by means of implant-supported single unit crownsTest patients have received a 2.9 Ø dental implant |
| Ø3.3mm (Control) | – | Other: Oral rehabilitation by means of implant-supported single unit crownsControl patients have received a 3.3 Ø dental implant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients affected by congenital missing with uni- or bilateral maxillary lateral incisors (i.e. 12 and/or 22)
Key inclusion criteria (4 listed)
- Patients affected by congenital missing with uni- or bilateral maxillary lateral incisors (i.e. 12 and/or 22)
- Patients with systemic health or controlled medical conditions
- Patients arrested skeletal growth as documented by two body height measurements at least one year apart not indicating continuous growth (Jensen, 2019)
- Written Informed Consent
Key exclusion criteria (6 listed)
- Patients contraindications to implant therapy (Hwang \& Wang, 2006, 2007) including
- Heavy smoking: >20 cigarettes/day
- Poor oral hygiene
- Compromised compliance
- Periodontally compromised conditions
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 |
|---|---|---|
| Oral rehabilitation by means of implant-supported single unit crownsSurgery: Implant placement; Prothetic rehabilitation: single unit crown | Other | Ø2.9mm (Test), Ø3.3mm (Control) |
Primary outcome
Peri-implant marginal bone level changes
Time frame: 1 year
Changes in mm at the 1-year follow-up visit
3 secondary outcomes
Implant Survival rate (%)
Time frame: 1-3-5 year
Aesthetic outcomes
Time frame: 1-3-5 year
PROMs
Time frame: 1-3-5 year
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 15 Jul 2024.
- Derived from this study: PubMed 40717340Roccuzzo A, Imber JC, Lempert J, Mancini L, Jensen SS. Five Year Clinical, Radiographic and Soft Tissue Profilometric Outcomes at Two Narrow-Diameter Implants to Replace Missing Maxillary Lateral Incisors. Clin Oral Implants Res. 2025 Nov;36(11):1412-1423. doi: 10.1111/clr.70010. Epub 2025 Jul 27.
- 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.
Simon Storgaard Jensen, Prof. study chair
Copenhagen University Hospital, Copenhagen, Denmark
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 Dental Implant Failed, run by University of Bern at 1 site in Denmark.
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 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: finished, as of the sponsor's last update on 15 Jul 2024. 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 Denmark. 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?
Peri-implant marginal bone level changes (time frame: 1 year). 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 NCT06500923, which also lists 1 linked publication.
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 15 Jul 2024.