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

Not Applicable

Recruiting

• Conditions: Completely Edentulous Patients

• Registration Number: NCT06755034
• Lead Sponsor: Frauke Müller

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-12-15
• Study First Submitted QC: 2024-12-23
• Study Start: 2025-01-01
• Status Verified: 2025-03
• Study First Posted: 2025-03-25
• Last Update Submitted: 2025-03-25
• Last Update Posted: 2025-03-26
• Primary Completion: 2031-12
• Study Completion: 2031-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 36

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University Clinics of Dental Medicine, University of Geneva; 🇨🇭 Geneva, Switzerland