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

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: Recruiting
• Conditions: Completely Edentulous Patients
• Intervention / Treatment: Device: c-SIMO; Device: m-SIMO

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sabrina Maniewicz; Phone Number: +4122 379 40 60; Email: sabrina.maniewicz@unige.ch

Study Locations

• Switzerland
  • Geneva, Switzerland, 1211
    • Recruiting
    • University Clinics of Dental Medicine, University of Geneva
    • Contact: Sabrina Maniewicz; Phone Number: +41223794060; Email: sabrina.maniewicz@unige.ch
    • Contact: Sabrina Maniewicz

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
OHIP-EDENT	Oral health-related quality of life questionnaire	From baseline to 5-year follow-up
DSI	Denture Satisfaction Index (questionnaire)	From baseline to 5-year follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Preferred chewing side	Asymmetry Index	From baseline to 5-year follow-up
Chewing efficiency	two-color mixing ability test	From baseline to 5-year follow-up
Occlusal analysis	Dental Prescale System	From baseline to 5-year follow-up
Plaque index	modified Plaque Index (modPI)	From implant loading to 5-year follow-up
Bleeding on probing	modified Bleeding Index (modBI)	From implant loading to 5-year follow-up
Pocket probing depth	Peri-implant probing depth	From implant loading to 5-year follow-up
Keratinized peri-implant tissues	Measurement of the keratinized tissue around implants	From implant loading to 5-year follow-up
Prosthodontic assessment	Number of prosthetic complications	From implant loading to 5-year follow-up
Peri-implant bone height	Measured on radiographs	From implant loading to 5-year follow-up

Collaborators and Investigators

• Sponsor: Frauke Müller
• Investigators: Principal Investigator: Sabrina Maniewicz, University of Geneva; Study Director: Frauke Müller, University of Geneva

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2025
• Primary Completion (Estimated): December 1, 2031
• Study Completion (Estimated): December 1, 2031

Study Registration Dates

• First Submitted: December 15, 2024
• First Submitted That Met QC Criteria: December 23, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Estimated): March 26, 2025
• Last Update Submitted That Met QC Criteria: March 25, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mouth Diseases; Stomatognathic Diseases; Tooth Diseases; Mouth, Edentulous
• Other Study ID 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