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Recruiting

NCT Number: NCT06755034

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

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.

Recruiting

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Clinics of Dental Medicine, University of Geneva

Geneva, Canton of Geneva, 1211, Switzerland

Location status: Recruiting

Location contact

Sabrina Maniewicz

CONTACT

[email protected]

+41223794060

Sabrina Maniewicz

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

c-SIMO

Device

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

m-SIMO

Device

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

Primary outcomes

  1. OHIP-EDENT

    Time frame: From baseline to 5-year follow-up

    Oral health-related quality of life questionnaire

  2. DSI

    Time frame: From baseline to 5-year follow-up

    Denture Satisfaction Index (questionnaire)

Secondary outcomes

  1. Preferred chewing side

    Time frame: From baseline to 5-year follow-up

    Asymmetry Index

  2. Chewing efficiency

    Time frame: From baseline to 5-year follow-up

    two-color mixing ability test

  3. Occlusal analysis

    Time frame: From baseline to 5-year follow-up

    Dental Prescale System

  4. Plaque index

    Time frame: From implant loading to 5-year follow-up

    modified Plaque Index (modPI)

  5. Bleeding on probing

    Time frame: From implant loading to 5-year follow-up

    modified Bleeding Index (modBI)

  6. Pocket probing depth

    Time frame: From implant loading to 5-year follow-up

    Peri-implant probing depth

  7. Keratinized peri-implant tissues

    Time frame: From implant loading to 5-year follow-up

    Measurement of the keratinized tissue around implants

  8. Prosthodontic assessment

    Time frame: From implant loading to 5-year follow-up

    Number of prosthetic complications

  9. Peri-implant bone height

    Time frame: From implant loading to 5-year follow-up

    Measured on radiographs

Study contacts

Contact information is provided by the study sponsor or research team.

Sabrina Maniewicz

CONTACT

[email protected]

+4122 379 40 60

Sponsors and collaborators

Lead sponsor

Frauke Müller

Other

Registry information

Official study 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

Acronym: c-SIMO

Important dates

Study start
2025
Primary completion
2031
Study completion
2031
First posted
Jan 1, 2025
Registry last updated
Mar 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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