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Mandibular Single Implant Overdenture: a Prospective Clinical Trial

Primary Purpose

Edentulous

Status
Withdrawn
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Denture implantation
Sponsored by
University Hospital, Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Edentulous focused on measuring single implant denture, Elderly with an unstable mandibular denture

Eligibility Criteria

70 Years - 90 Years (Older Adult)All SexesAccepts 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

Sites / Locations

  • University Hospital Ghent

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Elderly with an unstable mandibular denture.

Arm Description

Outcomes

Primary Outcome Measures

Patient satisfaction after insertion of the new complete dentures.
This will be measured by a questionnaire with 20 items.
Patient satisfaction after insertion of the complete dentures.
This will be measured by a questionnaire with 20 items.
Patient satisfaction post-surgical.
This will be measured by a questionnaire with 20 items.
Patient satisfaction after surgical procedure, functional loading.
This will be measured by a questionnaire with 20 items.
Patient satisfaction after loading the implant.
This will be measured by a questionnaire with 20 items.
Patient satisfaction after loading.
This will be measured by a questionnaire with 20 items.
Patient satisfaction after loading.
This will be measured by a questionnaire with 20 items.
Patient satisfaction after loading.
This will be measured by a questionnaire with 20 items.

Secondary Outcome Measures

Implant level : lost implants, loose implants, …
Soft tissue level : Peri-implant inflammation, bleeding index, probing depth
Denture related: soft tissue problems.
Repair management: type (fracture, matrix replacement, patrix activation, mechanical problems of the abutment, replacement of denture, relining, adjustment without adding new material) and number.
Maintenance - oral hygiene: Implant abutment: plaque index according to Mombelli, presence of calculus.
Maintenance - oral hygiene: Dentures using the denture plaque index by Augsburger and Elahi.

Full Information

First Posted
August 22, 2011
Last Updated
December 13, 2022
Sponsor
University Hospital, Ghent
Collaborators
Southern Implants, South Africa
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1. Study Identification

Unique Protocol Identification Number
NCT01421849
Brief Title
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

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Single implant in the mandible was finally not indicated due to lack of stability of the denture
Study Start Date
August 2011 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent
Collaborators
Southern Implants, South Africa

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Edentulous
Keywords
single implant denture, Elderly with an unstable mandibular denture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Elderly with an unstable mandibular denture.
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Denture implantation
Intervention Description
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 Outcome Measure Information:
Title
Patient satisfaction after insertion of the new complete dentures.
Description
This will be measured by a questionnaire with 20 items.
Time Frame
1 week after insertion of the new complete dentures.
Title
Patient satisfaction after insertion of the complete dentures.
Description
This will be measured by a questionnaire with 20 items.
Time Frame
8 weeks after insertion of the complete dentures.
Title
Patient satisfaction post-surgical.
Description
This will be measured by a questionnaire with 20 items.
Time Frame
1 week post-surgical.
Title
Patient satisfaction after surgical procedure, functional loading.
Description
This will be measured by a questionnaire with 20 items.
Time Frame
6-8 weeks after surgical procedure.
Title
Patient satisfaction after loading the implant.
Description
This will be measured by a questionnaire with 20 items.
Time Frame
1 week after loading the implant.
Title
Patient satisfaction after loading.
Description
This will be measured by a questionnaire with 20 items.
Time Frame
1 months after loading.
Title
Patient satisfaction after loading.
Description
This will be measured by a questionnaire with 20 items.
Time Frame
6 months after loading
Title
Patient satisfaction after loading.
Description
This will be measured by a questionnaire with 20 items.
Time Frame
1 year after loading
Secondary Outcome Measure Information:
Title
Implant level : lost implants, loose implants, …
Time Frame
From the first week post-surgical to 1 year after loading.
Title
Soft tissue level : Peri-implant inflammation, bleeding index, probing depth
Time Frame
From the first week post-surgical to 1 year after loading.
Title
Denture related: soft tissue problems.
Time Frame
From 1 week after insertion of the new complete dentures to 6 months after loading.
Title
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.
Title
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.
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacques Vanobbergen, MD, PhD
Organizational Affiliation
University Hospital Ghent, Belgium
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Ghent
City
Ghent
ZIP/Postal Code
9000
Country
Belgium

12. IPD Sharing Statement

Links:
URL
http://www.uzgent.be
Description
Related Info

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Mandibular Single Implant Overdenture: a Prospective Clinical Trial

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