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

NCT06755034 | Recruiting

• 1 other identifier: DGPA_2024_02
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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 center of the lower jaw.

Conditions

Completely Edentulous Patients

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

• Preferred chewing side

  From baseline to 5-year follow-up

• Chewing efficiency

  From baseline to 5-year follow-up

• Occlusal analysis

  From baseline to 5-year follow-up

• Plaque index

  From implant loading to 5-year follow-up

• Bleeding on probing

  From implant loading to 5-year follow-up

Study Arms (2)

c-SIMO

EXPERIMENTAL

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

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.

Device: m-SIMO

Interventions

c-SIMO DEVICE

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

c-SIMO

m-SIMO DEVICE

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

m-SIMO

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Frauke Müller: lead

Study Sites (1)

University Clinics of Dental Medicine, University of Geneva

Geneva, Canton of Geneva, 1211, Switzerland

RECRUITING

Study Officials

• Sabrina Maniewicz

  University of Geneva

  PRINCIPAL INVESTIGATOR

• Frauke Müller

  University of Geneva

  STUDY DIRECTOR

Central Study Contacts

Sabrina Maniewicz

CONTACT

+4122 379 40 60; sabrina.maniewicz@unige.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Head of Division

Study Record Dates

• First Submitted: December 15, 2024
• First Posted: January 1, 2025
• Study Start: January 1, 2025
• Primary Completion (Estimated): December 1, 2031
• Study Completion (Estimated): December 1, 2031
• Last Updated: March 26, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)