Mandibular Single Implant Overdenture: a Prospective Clinical Trial

Ghent University Hospital (UZ)

Status

Withdrawn

Conditions

Edentulous

Treatments

Procedure: Denture implantation

Study type

Interventional

Funder types

Other

Identifiers

NCT01421849

2011/381

Details and patient eligibility

About

Study hypothesis: that there would be no difference in patient satisfaction among institutionalised older people before and after treatment with a mandibular single implant-retained overdenture.

In a preliminary phase, a new denture is made or the old denture is adapted to provide a well-fitting denture.

Eight weeks after insertion of the new denture a single implant is placed in the centre of the mandibula. If the level of primary stability is sufficient to enable the implant to resist micromovement, the implant is immediately loaded . If not, the implant is loaded after 6 to 12 weeks. Primary stability is assessed by the final seating torque and by the clinician's interpretation and tactile sense of primary stability. Before, during and after the treatment patient satisfaction and clinical outcomes are evaluated by a 20 item questionnaire and a clinical examination.

Sex

All

Ages

70 to 90 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Edentulous residents of nursing homes treated in the mobile dental unit 'Gerodent'.
They have to be willing to commit to 1.5 year of participation in the study.
They have to be edentulous for at least one year before starting the implant procedure.

Exclusion criteria

Medical conditions contraindicating implant surgery (unregulated diabetes type II, bisphosphonates)
History of radiotherapy in the head and neck region
Insufficient bone for an implant of at least 10 mm length and 4 mm diameter
Previously treated with dental implants