Mandibular Single Implant Overdenture: a Prospective Clinical Trial

University Hospital, Ghent

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Conditions

Edentulous

Interventions

Denture implantationPROCEDURE

In a preliminary phase, a new denture is made according to standardized prosthodontic protocol or the old denture is adapted to provide a well-fitting denture. Eight weeks after insertion of the new denture an implant is placed under local anaesthetics in the centre of the mandibula.If primary stability is good, the implant is immediately loaded by the denture. If not, the implant is loaded after 6 to 12 weeks. Before, during and after the treatment patient satisfaction is evaluated by a 20 item questionnaire. Afterwards questionnaires are compared. After the insertion of the implant clinical evaluations take place at several moments. The total duration of the study will be 12 to 18 months.

Eligibility

Sex: ALLMin age: 70 YearsMax age: 90 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University Hospital Ghent

Ghent, Belgium