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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.

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.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00033233
Enrollment
20
Registered
2023-12-14
Start date
2010-07-01
Completion date
Unknown
Last updated
2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peri-implant health in elderly patients (ICD Code, K08.9) Atrophy of the edentulous jaw (ICD Code, K08.2) K08.9 K08.2

Interventions

Group 1: The study is single-armed, there is only one treatment group and no control group. Twenty participants with highly atrophic mandibles receive new, complete dentures at baseline
subsequently, four MDIs (diameter 1.8 mm) in the interforaminal region will be placed. The dentures are converted into implant overdentures retained by O-ring attachments immediately after the implant

Sponsors

zmk Bern
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
The primary outcome of the study is the evaluation of patient satisfaction after anchoring mandibular complete dentures using 4 interforaminal MDI®.

Secondary

MeasureTime frame
The secondary outcomes of the study are the evaluation of the long-term stability of the dental prosthesis on four MDI® implants: The wear of the matrices and patrices of the MDI system will be followed-up via retention force measurements over a period of 1, 3, 5 and 10 years. The MDI implants are followed up clinically and radiologically and the results obtained are compared with the generally recognised implant success criteria (implant survival/peri-implant bone resorption). In addition, the hygiene capability of the MDI® implants is followed-up using clinical mucosa indices and plaque indices.

Countries

Switzerland

Contacts

Public ContactSamir Abou-Ayash

zmk Bern

samir.abou-ayash@unibe.ch+41 31 684 07 39

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Jun 11, 2026