Clinical trial NCT01421849: Mandibular Single Implant Overdenture: a Prospective Clinical Trial
Official title: Patient Satisfaction and Clinical Outcomes Following Mandibular Single-implant-retained Overdenture Treatment in Residents of Nursing Homes: a Prospective Clinical Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Edentulous
Keywords: single implant denture
Elderly with an unstable mandibular denture
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: Southern Implants, South Africa
First posted: 2011-08-23
Enrollment: 0
Sex: ALL
Minimum age (years): 70
Maximum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Patient satisfaction after insertion of the new complete dentures.
timeFrame: 1 week after insertion of the new complete dentures.
measure: Patient satisfaction after insertion of the complete dentures.
timeFrame: 8 weeks after insertion of the complete dentures.
measure: Patient satisfaction post-surgical.
timeFrame: 1 week post-surgical.
measure: Patient satisfaction after surgical procedure, functional loading.
timeFrame: 6-8 weeks after surgical procedure.
measure: Patient satisfaction after loading the implant.
timeFrame: 1 week after loading the implant.
measure: Patient satisfaction after loading.
timeFrame: 1 months after loading.
measure: Patient satisfaction after loading.
timeFrame: 6 months after loading
measure: Patient satisfaction after loading.
timeFrame: 1 year after loading
Secondary outcomes:
measure: Implant level : lost implants, loose implants, …
timeFrame: From the first week post-surgical to 1 year after loading.
measure: Soft tissue level : Peri-implant inflammation, bleeding index, probing depth
timeFrame: From the first week post-surgical to 1 year after loading.
measure: Denture related: soft tissue problems.
timeFrame: From 1 week after insertion of the new complete dentures to 6 months after loading.
measure: Repair management: type (fracture, matrix replacement, patrix activation, mechanical problems of the abutment, replacement of denture, relining, adjustment without adding new material) and number.
timeFrame: From 8 weeks after insertion of the complete dentures to 6 months after loading.
measure: Maintenance - oral hygiene: Implant abutment: plaque index according to Mombelli, presence of calculus.
timeFrame: From 1 week after loading the implant to 6 months after loading.
measure: Maintenance - oral hygiene: Dentures using the denture plaque index by Augsburger and Elahi.
timeFrame: From 8 weeks after insertion of the complete dentures to 6 months after loading.
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
affiliation: University Hospital Ghent, Belgium
name: Jacques Vanobbergen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: