Stabilizing Mandibular Overdentures With a Single Implant Placed in the Canine Region of the Preferred Chewing Side

NCT ID: NCT06755034

Last Updated: 2025-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-01

Study Completion Date

2031-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Completely Edentulous Patients

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

c-SIMO

Placement of an implant in the mandibular canine area and using it to stabilize a pre-existing mandibular complete denture.

Group Type EXPERIMENTAL

c-SIMO

Intervention Type DEVICE

Placement of an implant in the mandibular canine area and using it to stabilize a pre-existing mandibular complete denture.

m-SIMO

Placement of an implant in the midline of the mandible and using it to stabilize a pre-existing mandibular complete denture.

Group Type ACTIVE_COMPARATOR

m-SIMO

Intervention Type DEVICE

Placement of an implant in the midline of the mandible and using it to stabilize a pre-existing mandibular complete denture.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

c-SIMO

Placement of an implant in the mandibular canine area and using it to stabilize a pre-existing mandibular complete denture.

Intervention Type DEVICE

m-SIMO

Placement of an implant in the midline of the mandible and using it to stabilize a pre-existing mandibular complete denture.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Frauke Müller

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Frauke Müller

Professor, Head of Division

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Sabrina Maniewicz

Role: PRINCIPAL_INVESTIGATOR

University of Geneva

Frauke Müller

Role: STUDY_DIRECTOR

University of Geneva

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University Clinics of Dental Medicine, University of Geneva

Geneva, Canton of Geneva, Switzerland

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Switzerland

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Sabrina Maniewicz

Role: CONTACT

+4122 379 40 60

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Sabrina Maniewicz

Role: primary

+41223794060

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

DGPA_2024_02

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.