Prospective, controlled, clinical cohort study on the use of the MDI® system for the stabilisation of mandibular complete dentures using 4 MDI from IMTEC (3M ESPE) in edentulous patients.
- Conditions
- Peri-implant health in elderly patients (ICD Code, K08.9)Atrophy of the edentulous jaw (ICD Code, K08.2)K08.9K08.2Disorder of teeth and supporting structures, unspecifiedAtrophy of edentulous alveolar ridge
- Registration Number
- DRKS00033233
- Lead Sponsor
- zmk Bern
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 20
People/participants who have been edentulous for at least 6 months and have been fitted with sufficient complete dentures for at least 6 weeks. Furthermore, patients must have sufficient bone in the mandible to allow implant placement. The study subjects will not be recruited separately, but will be selected from the clinic's existing patient population: The potential study subjects will be treated with MDI IMTEC implants even if they decline to participate in the study. The study subjects must not fulfil the following exclusion criteria.
psychologically
- Participants who are not willing to come to the follow-up appointments
- Participants who are addicted to alcohol or drugs
- Participants with pathologically increased dental treatment anxiety
- Participants who are cognitively incapable of understanding and completing the study questionnaire
systemic
- Uncontrolled diabetes mellitus
- Post-radiotherapy in the head and neck area
- Infectious diseases such as active tuberculosis, acute hepatitis, HIV
- Immunosuppressive drug therapy
- Osteopathies, e.g. Paget's disease
- Taking medication that can have a negative effect on bone metabolism, e.g. bisphosphonates
- General illnesses that do not allow the described course of treatment
local
- Pronounced xerostomia
- Participants with insufficient bone stock for implantation
- Myoarthropathies
- Participants with inadequate oral hygiene
- Participants with untreated or unhealed oral mucosal disease
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method