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

Frauke Müller

Status: Enrolling

Conditions: Completely Edentulous Patients

Treatments: Device: m-SIMO; Device: c-SIMO

Study type: Interventional

Funder types: Other

Identifiers

NCT06755034

DGPA_2024_02

Details and patient eligibility

About

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.

Enrollment: 36 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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36 participants in 2 patient groups

c-SIMO

Experimental group

Description:

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

Treatment:

Device: c-SIMO

m-SIMO

Active Comparator group

Description:

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

Treatment:

Device: m-SIMO