Overview

This trial is active, not recruiting.

Condition edentulous
Treatment denture implantation
Sponsor University Hospital, Ghent
Collaborator Southern Implants, South Africa
Start date August 2011
End date December 2015
Trial size 50 participants
Trial identifier NCT01421849, 2011/381

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model crossover assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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.

Primary Outcomes

Measure
Patient satisfaction after insertion of the new complete dentures.
time frame: 1 week after insertion of the new complete dentures.
Patient satisfaction after insertion of the complete dentures.
time frame: 8 weeks after insertion of the complete dentures.
Patient satisfaction post-surgical.
time frame: 1 week post-surgical.
Patient satisfaction after surgical procedure, functional loading.
time frame: 6-8 weeks after surgical procedure.
Patient satisfaction after loading the implant.
time frame: 1 week after loading the implant.
Patient satisfaction after loading.
time frame: 1 months after loading.
Patient satisfaction after loading.
time frame: 6 months after loading
Patient satisfaction after loading.
time frame: 1 year after loading

Secondary Outcomes

Measure
Implant level : lost implants, loose implants, …
time frame: From the first week post-surgical to 1 year after loading.
Soft tissue level : Peri-implant inflammation, bleeding index, probing depth
time frame: From the first week post-surgical to 1 year after loading.
Denture related: soft tissue problems.
time frame: From 1 week after insertion of the new complete dentures to 6 months after loading.
Repair management: type (fracture, matrix replacement, patrix activation, mechanical problems of the abutment, replacement of denture, relining, adjustment without adding new material) and number.
time frame: From 8 weeks after insertion of the complete dentures to 6 months after loading.
Maintenance - oral hygiene: Implant abutment: plaque index according to Mombelli, presence of calculus.
time frame: From 1 week after loading the implant to 6 months after loading.
Maintenance - oral hygiene: Dentures using the denture plaque index by Augsburger and Elahi.
time frame: From 8 weeks after insertion of the complete dentures to 6 months after loading.

Eligibility Criteria

Male or female participants from 70 years up to 90 years old.

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

Additional Information

Official title Patient Satisfaction and Clinical Outcomes Following Mandibular Single-implant-retained Overdenture Treatment in Residents of Nursing Homes: a Prospective Clinical Trial
Principal investigator Jacques Vanobbergen, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in December 2014.
Information provided to ClinicalTrials.gov by University Hospital, Ghent.