Stabilizing Mandibular Overdentures with a Single Implant Placed in the Canine Region of the Preferred Chewing Side (c-SIMO)

March 25, 2025 updated by: Frauke Müller

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Switzerland
      • Geneva, Switzerland, 1211
        • Recruiting
        • University Clinics of Dental Medicine, University of Geneva
        • Contact:
        • Contact:
          • Sabrina Maniewicz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: c-SIMO
Placement of an implant in the mandibular canine area and using it to stabilize a pre-existing mandibular complete denture.
Device: c-SIMO
Placement of an implant in the mandibular canine area and using it to stabilize a pre-existing mandibular complete denture.
Active Comparator: m-SIMO
Placement of an implant in the midline of the mandible and using it to stabilize a pre-existing mandibular complete denture.
Device: m-SIMO
Placement of an implant in the midline of the mandible and using it to stabilize a pre-existing mandibular complete denture.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
OHIP-EDENT
Time Frame: From baseline to 5-year follow-up
Oral health-related quality of life questionnaire
From baseline to 5-year follow-up
DSI
Time Frame: From baseline to 5-year follow-up
Denture Satisfaction Index (questionnaire)
From baseline to 5-year follow-up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Preferred chewing side
Time Frame: From baseline to 5-year follow-up
Asymmetry Index
From baseline to 5-year follow-up
Chewing efficiency
Time Frame: From baseline to 5-year follow-up
two-color mixing ability test
From baseline to 5-year follow-up
Occlusal analysis
Time Frame: From baseline to 5-year follow-up
Dental Prescale System
From baseline to 5-year follow-up
Plaque index
Time Frame: From implant loading to 5-year follow-up
modified Plaque Index (modPI)
From implant loading to 5-year follow-up
Bleeding on probing
Time Frame: From implant loading to 5-year follow-up
modified Bleeding Index (modBI)
From implant loading to 5-year follow-up
Pocket probing depth
Time Frame: From implant loading to 5-year follow-up
Peri-implant probing depth
From implant loading to 5-year follow-up
Keratinized peri-implant tissues
Time Frame: From implant loading to 5-year follow-up
Measurement of the keratinized tissue around implants
From implant loading to 5-year follow-up
Prosthodontic assessment
Time Frame: From implant loading to 5-year follow-up
Number of prosthetic complications
From implant loading to 5-year follow-up
Peri-implant bone height
Time Frame: From implant loading to 5-year follow-up
Measured on radiographs
From implant loading to 5-year follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Frauke Müller

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sabrina Maniewicz, University of Geneva
  • Study Director: Frauke Müller, University of Geneva

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2031

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2031

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 15, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 23, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 26, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 25, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DGPA_2024_02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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