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Mandibular Implants in Elderly Patients

Primary Purpose

Edentulous Complete Denture Wearers

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Implant placement
Conventional reline
Sponsored by
University of Geneva, Switzerland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Edentulous Complete Denture Wearers focused on measuring edentulous, complete denture

Eligibility Criteria

75 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 75 years or older
  • living institutionalized or receiving help for the ADL
  • edentulous
  • wearing complete dentures
  • the lower denture had to cause discomfort to the degree that the patients were seeking treatment

Exclusion Criteria:

  • severe clinical depression
  • dementia
  • poorly controlled diabetes
  • immunosuppression
  • treatment with bisphosphonates
  • condition precluding the surgical intervention for implant placement

Sites / Locations

  • University of Geneva

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

implant placement

denture reline

Arm Description

insertion of 2 interforaminal mandibular implants and conversion of the lower complete denture to an implant-overdenture

conventional reline of mandibular complete denture

Outcomes

Primary Outcome Measures

Change from Baseline in Denture satisfaction
VAS-scale score to evaluate the subjective satisfaction with the denture

Secondary Outcome Measures

Change from Baseline in OHRQoL
OHIP-Edent questionnaire, 20 questions
Change from Baseline in cognitive function
Mini-Mental State Examination, to evaluate cognitive function (Folstein et al. 1975) Trail-making test A and B Verbal fluency test
Change from Baseline in Independence
IADL Instrumental Activities of Daily Living Scale (Lawton and Brody, 1969) MIF Measure of functional independence
Change from Baseline in MNA
Mini-nutritional Assessement questionnaire (Guigoz 1994)
Change from Baseline in Blood markers
Albumin, Folic acid, Vitamin B12 (VitB12), Hemoglobin (Hb), C-reactive protein (CRP)
Change from Baseline in BMI
Body Mass Index kg/m2
Change from Insertion in implant survival
inserted implants in vivo
Change from Insertion in Pocket depth
mesial and distal peri-implant probing depth
Change from Insertion in Plaque index
Plaque index on implants (Silness & Loe 1963) Denture plaque index
Change from Insertion in peri-implant bone loss
mesial and distal peri-implant bone loss, as evaluated on intraoral radiographs or OPTs
Change from Baseline in Chewing efficiency
two color mixing test with bi-colored chewing gum (Schimmel et al 2007)
Change from Baseline in Maximum bite force
unilateral maximal bite force measured with force gauge
Change from Baseline in Stimulated Saliva Flow Rate
whole saliva collected after chewing wax for 2 minutes on one side
Changes from Baseline in Masseter Muscle Thickness
ultrasound measurements of the masseter muscle thickness in contracted and relaxed state

Full Information

First Posted
August 16, 2013
Last Updated
April 27, 2021
Sponsor
University of Geneva, Switzerland
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1. Study Identification

Unique Protocol Identification Number
NCT01928004
Brief Title
Mandibular Implants in Elderly Patients
Official Title
Implant-supported Mandibular Overdentures in Very Old Adults - a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
April 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Geneva, Switzerland

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to investigate denture satisfaction following the conversion of existing mandibular complete dentures to implant-overdentures (IOD) in very old edentulous patients who depend on help for activities of daily living (ADL) and evaluate secondary endpoints such as functional, structural, nutritional, cognitive and patient-centered outcome measures.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Edentulous Complete Denture Wearers
Keywords
edentulous, complete denture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
implant placement
Arm Type
Experimental
Arm Description
insertion of 2 interforaminal mandibular implants and conversion of the lower complete denture to an implant-overdenture
Arm Title
denture reline
Arm Type
Active Comparator
Arm Description
conventional reline of mandibular complete denture
Intervention Type
Device
Intervention Name(s)
Implant placement
Other Intervention Name(s)
Straumann Standard Implants® (SLA surface, 8mm length, RN, 4.1mm diameter), Locator® attachments (Zest Anchors: Escondido, CA, USA)
Intervention Description
Participants received two Straumann Standard Implants® in the interforaminal region using the recommended surgical protocol. The implants were loaded using Locator® attachments after six to eight weeks healing time by transforming the existing lower denture to an IOD.
Intervention Type
Procedure
Intervention Name(s)
Conventional reline
Intervention Description
conventional reline of the existing mandibular complete denture
Primary Outcome Measure Information:
Title
Change from Baseline in Denture satisfaction
Description
VAS-scale score to evaluate the subjective satisfaction with the denture
Time Frame
at 3, 12, 24 and 36 months
Secondary Outcome Measure Information:
Title
Change from Baseline in OHRQoL
Description
OHIP-Edent questionnaire, 20 questions
Time Frame
at 3, 12, 24 adn 36 months
Title
Change from Baseline in cognitive function
Description
Mini-Mental State Examination, to evaluate cognitive function (Folstein et al. 1975) Trail-making test A and B Verbal fluency test
Time Frame
at 12, 24 and 36 months
Title
Change from Baseline in Independence
Description
IADL Instrumental Activities of Daily Living Scale (Lawton and Brody, 1969) MIF Measure of functional independence
Time Frame
at 12, 24 and 36 months
Title
Change from Baseline in MNA
Description
Mini-nutritional Assessement questionnaire (Guigoz 1994)
Time Frame
at 3, 12, 24 and 36 months
Title
Change from Baseline in Blood markers
Description
Albumin, Folic acid, Vitamin B12 (VitB12), Hemoglobin (Hb), C-reactive protein (CRP)
Time Frame
at 3, 12, 24 and 36 months
Title
Change from Baseline in BMI
Description
Body Mass Index kg/m2
Time Frame
at 12, 24 and 36 months
Title
Change from Insertion in implant survival
Description
inserted implants in vivo
Time Frame
at 3, 12, 24 and 36 months
Title
Change from Insertion in Pocket depth
Description
mesial and distal peri-implant probing depth
Time Frame
at 3, 12, 24 and 36 months
Title
Change from Insertion in Plaque index
Description
Plaque index on implants (Silness & Loe 1963) Denture plaque index
Time Frame
at 3, 12, 24 and 36 months
Title
Change from Insertion in peri-implant bone loss
Description
mesial and distal peri-implant bone loss, as evaluated on intraoral radiographs or OPTs
Time Frame
at 3, 12, 24 and 36 months
Title
Change from Baseline in Chewing efficiency
Description
two color mixing test with bi-colored chewing gum (Schimmel et al 2007)
Time Frame
at Intervention, 3, 12, 24 and 36 months
Title
Change from Baseline in Maximum bite force
Description
unilateral maximal bite force measured with force gauge
Time Frame
at Intervention, 3, 12, 24 and 36 months
Title
Change from Baseline in Stimulated Saliva Flow Rate
Description
whole saliva collected after chewing wax for 2 minutes on one side
Time Frame
at Intervention, 3, 12, 24 and 36 months
Title
Changes from Baseline in Masseter Muscle Thickness
Description
ultrasound measurements of the masseter muscle thickness in contracted and relaxed state
Time Frame
at 3, 12, 24 and 36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 75 years or older living institutionalized or receiving help for the ADL edentulous wearing complete dentures the lower denture had to cause discomfort to the degree that the patients were seeking treatment Exclusion Criteria: severe clinical depression dementia poorly controlled diabetes immunosuppression treatment with bisphosphonates condition precluding the surgical intervention for implant placement
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frauke Müller, Prof. Dr. med. dent.
Organizational Affiliation
University of Geneva
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Geneva
City
Geneva
ZIP/Postal Code
1205
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
24158342
Citation
Muller F, Duvernay E, Loup A, Vazquez L, Herrmann FR, Schimmel M. Implant-supported mandibular overdentures in very old adults: a randomized controlled trial. J Dent Res. 2013 Dec;92(12 Suppl):154S-60S. doi: 10.1177/0022034513509630. Epub 2013 Oct 24.
Results Reference
result
PubMed Identifier
30500094
Citation
Maniewicz S, Duvernay E, Srinivasan M, Perneger T, Schimmel M, Muller F. Effect of implant-supported mandibular overdentures versus reline on masticatory performance and salivary flow rates in very old adults-A randomized clinical trial. Clin Oral Implants Res. 2019 Jan;30(1):59-67. doi: 10.1111/clr.13392. Epub 2018 Dec 30.
Results Reference
result

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Mandibular Implants in Elderly Patients

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