Completely Edentulous Patientsc-SIMONCT06755034
Stabilizing Mandibular Overdentures With a Single Implant Placed in the Canine Region of the Preferred Chewing Side
A study testing c-SIMO and m-SIMO in people with Completely Edentulous Patients, run by Frauke Müller at 1 site in Switzerland.
Trial summary
The investigators are evaluating the use of a single implant to stabilize complete dentures in the lower jaw, in the canine region of the preferred chewing side. They are conducting this study to determine whether this treatment concept gives satisfactory results, and how it compares with the standard position in the… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Completely Edentulous Patients
- What is being tested?
- c-SIMO and m-SIMO
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jan 2025to Dec 2031
- Phase
- Interventional
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent signed by the subject
- Age ≥ 60 years
- Edentulous and wearing sufficient complete maxillary and mandibular dentures or ones that can be rendered sufficient via a reline and/or renewal of the prosthetic teeth
- Healed edentulous mandible (minimum 6-8 weeks since last extraction in the anterior zone (4-4) and one year in the posterior zone (5-8))
- Physical status ASA1 and ASA2
Who cannot join
- Contraindications to the medical devices used, e.g. known hypersensitivity or allergy
- Vulnerable subjects
- Enrollment of the investigator, his/her family members, employees and other dependent persons
- Known or suspected non-compliance, drug or alcohol abuse
- Inability to perform adequate oral hygiene
- Inability to follow the procedures of the investigation, e.g. due to language problems, psychological disorders, dementia, Parkinson etc. of the subject (Dementia: clock-drawing test score ≤ 5)
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- Surgical risk factors such as, but not limited to, uncontrolled diabetes, immunosuppression, radiation, chemotherapy, or antiresorptive medication (ex. Bisphosphonates)
- Heavy smoking habit: >20 cig/d
- Reported severe bruxism or clenching habits, clinically present oro-facial pain
- Depression: Geriatric Depression Scale > 9
- Xerostomia: SSFR ≤ 0.7ml/min
- Ridge dimensions <6 mm (width) by 10 mm (height) in the canine or midline area
- Ridge defects requiring bone augmentation procedures
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
University Clinics of Dental Medicine, University of Geneva
Geneva, Canton of Geneva, 1211
Sabrina Maniewicz, +41223794060, sabrina.maniewicz@unige.ch
Sabrina Maniewicz
About this study
Official title: Stabilizing Mandibular Overdentures With a Single Implant Placed in the Canine Region of the Preferred Chewing Side Compared to the Midline Single-implant Overdenture Treatment Concept: an RCT With 5 Years of Follow-up
The investigators are evaluating the use of a single implant to stabilize complete dentures in the lower jaw, in the canine region of the preferred chewing side. They are conducting this study to determine whether this treatment concept gives satisfactory results, and how it compares with the standard position in the center of the lower jaw.
- Conditions
- Completely Edentulous Patients
- Being tested
- c-SIMO, m-SIMO
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
c-SIMODevice
Placement of an implant in the mandibular canine area and using it to stabilize a pre-existing mandibular complete denture.
m-SIMODevice
Placement of an implant in the midline of the mandible and using it to stabilize a pre-existing mandibular complete denture.
| Study group | Role | What they receive |
|---|---|---|
| c-SIMO | Experimental | Placement of an implant in the mandibular canine area and using it to stabilize a pre-existing mandibular complete denture. Receives: Device: c-SIMO |
| m-SIMO | Active comparator | Placement of an implant in the midline of the mandible and using it to stabilize a pre-existing mandibular complete denture. Receives: Device: m-SIMO |
What is being measured
The primary outcome is the main question the study is designed to answer.
OHIP-EDENT
Oral health-related quality of life questionnaire
Measured: From baseline to 5-year follow-up
DSI
Denture Satisfaction Index (questionnaire)
Measured: From baseline to 5-year follow-up
Secondary outcomes (9)
Preferred chewing side
Asymmetry Index
Measured: From baseline to 5-year follow-up
Chewing efficiency
two-color mixing ability test
Measured: From baseline to 5-year follow-up
Occlusal analysis
Dental Prescale System
Measured: From baseline to 5-year follow-up
Plaque index
modified Plaque Index (modPI)
Measured: From implant loading to 5-year follow-up
Bleeding on probing
modified Bleeding Index (modBI)
Measured: From implant loading to 5-year follow-up
Pocket probing depth
Peri-implant probing depth
Measured: From implant loading to 5-year follow-up
Keratinized peri-implant tissues
Measurement of the keratinized tissue around implants
Measured: From implant loading to 5-year follow-up
Prosthodontic assessment
Number of prosthetic complications
Measured: From implant loading to 5-year follow-up
Peri-implant bone height
Measured on radiographs
Measured: From implant loading to 5-year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2025
- Study start1 Jan 2025
- Primary completionDec 2031 (estimated)
- Study completionDec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Completely Edentulous PatientsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Frauke Müller
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Frauke Müller, University of Geneva, Switzerland
- Investigators
- Sabrina Maniewicz, Principal investigator, University of Geneva, SwitzerlandFrauke Müller, Study director, University of Geneva, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06755034
- Sponsor's protocol ID
- DGPA_2024_02
- Acronym
- c-SIMO
- Status last verified
- Mar 2025
- First submitted
- 15 Dec 2024
- Last updated
- 26 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 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stabilizing Mandibular Overdentures With a Single Implant Placed in the Canine Region of the Preferred Chewing Side Compared to the Midline Single-implant Overdenture Treatment Concept: an RCT With 5 Years of Follow-up
- ClinicalTrials.gov ID
- NCT06755034
- Acronym / sponsor ID
- c-SIMO / DGPA_2024_02
- Conditions
- Completely Edentulous Patients
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Frauke MüllerUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- Dec 2031 (estimated)
- Study completion
- Dec 2031 (estimated)
- First posted
- 1 Jan 2025 (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.
The investigators are evaluating the use of a single implant to stabilize complete dentures in the lower jaw, in the canine region of the preferred chewing side. They are conducting this study to determine whether this treatment concept gives satisfactory results, and how it compares with the standard position in the center of the lower jaw.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| c-SIMO | Experimental | Device: c-SIMOPlacement of an implant in the mandibular canine area and using it to stabilize a pre-existing mandibular complete denture. |
| m-SIMO | Active comparator | Device: m-SIMOPlacement of an implant in the midline of the mandible and using it to stabilize a pre-existing mandibular complete denture. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Informed consent signed by the subject
- Age ≥ 60 years
- Edentulous and wearing sufficient complete maxillary and mandibular dentures or ones that can be rendered sufficient via a reline and/or renewal of the prosthetic teeth
- Healed edentulous mandible (minimum 6-8 weeks since last extraction in the anterior zone (4-4) and one year in the posterior zone (5-8))
- Physical status ASA1 and ASA2
Key exclusion criteria (13 listed)
- Contraindications to the medical devices used, e.g. known hypersensitivity or allergy
- Vulnerable subjects
- Enrollment of the investigator, his/her family members, employees and other dependent persons
- Known or suspected non-compliance, drug or alcohol abuse
- Inability to perform adequate oral hygiene
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 |
|---|---|---|
| c-SIMOPlacement of an implant in the mandibular canine area and using it to stabilize a pre-existing mandibular complete denture. | Device | c-SIMO |
| m-SIMOPlacement of an implant in the midline of the mandible and using it to stabilize a pre-existing mandibular complete denture. | Device | m-SIMO |
Primary outcome
OHIP-EDENT
Time frame: From baseline to 5-year follow-up
Oral health-related quality of life questionnaire
DSI
Time frame: From baseline to 5-year follow-up
Denture Satisfaction Index (questionnaire)
9 secondary outcomes
Preferred chewing side
Time frame: From baseline to 5-year follow-up
Chewing efficiency
Time frame: From baseline to 5-year follow-up
Occlusal analysis
Time frame: From baseline to 5-year follow-up
Plaque index
Time frame: From implant loading to 5-year follow-up
Bleeding on probing
Time frame: From implant loading to 5-year follow-up
Pocket probing depth
Time frame: From implant loading to 5-year follow-up
Keratinized peri-implant tissues
Time frame: From implant loading to 5-year follow-up
Prosthodontic assessment
Time frame: From implant loading to 5-year follow-up
Peri-implant bone height
Time frame: From implant loading to 5-year follow-up
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 26 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.
Sabrina Maniewicz principal investigator
University of Geneva, Switzerland
Frauke Müller study director
University of Geneva, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing c-SIMO and m-SIMO in people with Completely Edentulous Patients, run by Frauke Müller at 1 site in Switzerland.
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 5 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 26 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 Switzerland. 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?
Contact Sabrina Maniewicz (+4122 379 40 60, sabrina.maniewicz@unige.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OHIP-EDENT (time frame: From baseline to 5-year follow-up). The study lists 2 primary outcomes in all. 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 26 Mar 2025.