Stabilization of a Full Lower DentureNCT01064843
Clinical Evaluation of the Mandibular Mini-Implant Overdenture
An observational study of Stabilization of a Full Lower Denture and Edentulism in Lower Jaw, run by Solventum US LLC at 1 site in Canada.
Trial summary
Stabilization of existing full lower dentures by means of mini-dental implants (MDI). To test whether 4 mini-implants placed at the front of the lower jaw can stabilize an immediately-modified existing lower denture. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stabilization of a Full Lower Denture, Edentulism in Lower Jaw, Lower Denture Made Within Last Few Years
- What is being tested?
- Imtec MDI
- Type of treatment
- Medical device
- How many people
- 80 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2010to Mar 2014
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Dental implant
Who may be able to join
- Completely edentulous with last tooth extraction 2 years ago or longer.
- Patients requesting implant stabilization of existing lower conventional denture.
- Adequate space in anterior mandible for placement of 4 MDI implants.
- Able to maintain adequate oral hygiene and keep dentures clean.
- Healthy enough to have minor surgical procedures.
- Have adequate understanding of written and spoken English or French.
- Capable of providing written informed consent.
Who cannot join
- Not enough room in mandibular bone for implant height.
- Has acute or chronic symptoms of parafunctional disorders.
- History of radiotherapy to orofacial region.
- Are or have been taking bisphosphonate IV or other medications (to be evaluated by the researcher).
- Health conditions that may jeopardize treatment (to be evaluated by the researcher).
- Unable or unwilling to return for evaluations or study recalls.
Trial locations and contacts
1 site in 1 country.
About this study
Stabilization of existing full lower dentures by means of mini-dental implants (MDI). To test whether 4 mini-implants placed at the front of the lower jaw can stabilize an immediately-modified existing lower denture.
Read the detailed description
To test whether the percentage of case successes of these lower dentures supported by 4 MDIs is equal to or greater than 95% at 1 year. Success is defined as a denture supported by implants that is functioning in the way it was intended.
- Conditions
- Stabilization of a Full Lower Denture, Edentulism in Lower Jaw, Lower Denture Made Within Last Few Years
- Being tested
- Imtec MDI
- Keywords
- Edentulous, Edentulism, Lower denture, Mini dental implant, Imtec MDI, Denture stabilization, Case success rate of overdentures stabilized by MDI, General satisfaction of patients with this treatment, Oral health-related quality of life of these patients, Cost estimates
- Medical subject headings
- Mouth, Edentulous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imtec MDIDevice
4 Imtec MDI
| Study group | Role | What they receive |
|---|---|---|
| 4 Imtec mini-dental implants (MDI) | 4 Imtec MDI Receives: Device: Imtec MDI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of mandibular overdentures supported by 4 MDIs placed in the interforaminal region in the long term.
Measured: 3 years
Secondary outcomes (1)
Oral health-related quality of life and general satisfaction of patients.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2010 (estimated)
- Study startFeb 2010
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stabilization of a Full Lower DentureStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Solventum US LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- McGill University, 3M
- Responsible party
- Sponsor
- Investigators
- Jocelyne Feine, DDS, MSc, HDR, Principal investigator, Professor, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01064843
- Sponsor's protocol ID
- 3M ESPE CR-09-020
- Status last verified
- Nov 2024
- First submitted
- 5 Feb 2010
- Last updated
- 2 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the Mandibular Mini-Implant Overdenture
- ClinicalTrials.gov ID
- NCT01064843
- Acronym / sponsor ID
- 3M ESPE CR-09-020
- Conditions
- Stabilization of a Full Lower Denture, Edentulism in Lower Jaw, Lower Denture Made Within Last Few Years
- Keywords
- Edentulous, Edentulism, Lower denture, Mini dental implant, Imtec MDI, Denture stabilization, Case success rate of overdentures stabilized by MDI, General satisfaction of patients with this treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Solventum US LLCIndustry (pharma, biotech, devices)
- Collaborators
- McGill University, 3M
- Study start
- Feb 2010
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 9 Feb 2010 (estimated)
- 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.
Stabilization of existing full lower dentures by means of mini-dental implants (MDI). To test whether 4 mini-implants placed at the front of the lower jaw can stabilize an immediately-modified existing lower denture.
Detailed description
To test whether the percentage of case successes of these lower dentures supported by 4 MDIs is equal to or greater than 95% at 1 year. Success is defined as a denture supported by implants that is functioning in the way it was intended.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 4 Imtec mini-dental implants (MDI) | – | Device: Imtec MDI4 Imtec MDI |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Dental implant
Key inclusion criteria (7 listed)
- Completely edentulous with last tooth extraction 2 years ago or longer.
- Patients requesting implant stabilization of existing lower conventional denture.
- Adequate space in anterior mandible for placement of 4 MDI implants.
- Able to maintain adequate oral hygiene and keep dentures clean.
- Healthy enough to have minor surgical procedures.
Key exclusion criteria (6 listed)
- Not enough room in mandibular bone for implant height.
- Has acute or chronic symptoms of parafunctional disorders.
- History of radiotherapy to orofacial region.
- Are or have been taking bisphosphonate IV or other medications (to be evaluated by the researcher).
- Health conditions that may jeopardize treatment (to be evaluated by the researcher).
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 |
|---|---|---|
| Imtec MDI4 Imtec MDI | Device | 4 Imtec mini-dental implants (MDI) |
Primary outcome
Success rate of mandibular overdentures supported by 4 MDIs placed in the interforaminal region in the long term.
Time frame: 3 years
1 secondary outcome
Oral health-related quality of life and general satisfaction of patients.
Time frame: 3 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 2 Dec 2024.
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.
Jocelyne Feine, DDS, MSc, HDR principal investigator
Professor, Principal Investigator
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 Stabilization of a Full Lower Denture and Edentulism in Lower Jaw, run by Solventum US LLC at 1 site in Canada.
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 7 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 2 Dec 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 Canada. 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?
Success rate of mandibular overdentures supported by 4 MDIs placed in the interforaminal region in the long term. (time frame: 3 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 2 Dec 2024.