Mandibular mini-implants supporting new overdentures or existing complete dentures: a randomized controlled clinical study.

Not Applicable

Recruiting

Conditions: Edentulous mandible with an insufficient complete denture

Registration Number: DRKS00025025

Lead Sponsor: niversität Zürich, Zentrum für Zahnmedizin, Klinik für Rekonstruktive Zahnmedizin

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 22

Inclusion Criteria

Signed informed consent form
- Edentulous mandible with an insufficient complete denture (patient’s point of view)
- Edentulism in the mandible since at least 6 months
- Existing complete dentures (mandible at least 6 months old)
- Sufficient complete denture in the maxilla (patient’s point of view)
- Presence of an adequate

Exclusion Criteria

- Expected treatment need in the maxilla
- Known or suspected non-compliance, drug or alcohol abuse
- Medical history in which any elective oral surgical intervention would be contraindicated
- Heavy smoking (>10 cigarettes/day)
- Women who are pregnant or breast feeding at date of inclusion

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Oral Health-Related Quality of Life (OHRQoL) 5 years after insertion of the final prosthesis, using a questionnaire

Secondary Outcome Measures

Name	Time	Method
Secondary endpoints will be assessed at insertion of the final prosthesis as well as at each follow-up visit (6 months, 1- / 3- and 5-years):<br>- Technical outcomes<br>- Biological outcomes and complications<br>- Radiographic outcomes<br>- Esthetic outcomes<br>- Patient related outcome measures (PROMS)<br>- Need for maintenance, total cost of the treatment<br>- Masticatory efficiency