NCT01421849

Mandibular Single Implant Overdenture: a Prospective Clinical Trial

Patient Satisfaction and Clinical Outcomes Following Mandibular Single-implant-retained Overdenture Treatment in Residents of Nursing Homes: a Prospective Clinical Trial

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University Hospital, Ghent · Academic / Other
• Sex: All
• Age: 70 Years – 90 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Edentulous

Interventions

Type	Name	Description
PROCEDURE	Denture implantation	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.

Timeline

• Start date: 2011-08-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2011-08-23
• Last updated: 2022-12-15

Locations

1 site across 1 country: Belgium