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Recruiting NCT06755034

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

No phase Interventional Completely Edentulous Patients

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: c-SIMO, m-SIMO.
Who it may be relevant to
Registry conditions: Completely Edentulous Patients. Basic parameters: from 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Device c-SIMO
    Placement of an implant in the mandibular canine area 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.

Primary outcome measures

  • OHIP-EDENT [Time frame: From baseline to 5-year follow-up]
  • DSI [Time frame: From baseline to 5-year follow-up]
Secondary outcome measures (9)
  • Preferred chewing side [Time frame: From baseline to 5-year follow-up]
  • Chewing efficiency [Time frame: From baseline to 5-year follow-up]
  • Occlusal analysis [Time frame: From baseline to 5-year follow-up]
  • Plaque index [Time frame: From implant loading to 5-year follow-up]
  • Bleeding on probing [Time frame: From implant loading to 5-year follow-up]
  • Pocket probing depth [Time frame: From implant loading to 5-year follow-up]
  • Keratinized peri-implant tissues [Time frame: From implant loading to 5-year follow-up]
  • Prosthodontic assessment [Time frame: From implant loading to 5-year follow-up]
  • Peri-implant bone height [Time frame: From implant loading to 5-year follow-up]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Switzerland · 1 center
  • University Clinics of Dental Medicine, University of Geneva — Geneva

Identifiers

NCT: NCT06755034 · DGPA_2024_02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗