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Mandibular Implants in Elderly Patients

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ClinicalTrials.gov Identifier: NCT01928004
Recruitment Status : Unknown
Verified July 2016 by Frauke Müller, University of Geneva, Switzerland.
Recruitment status was:  Active, not recruiting
First Posted : August 23, 2013
Last Update Posted : July 13, 2016
Sponsor:
Collaborator:
University of Geneva, Switzerland
Information provided by (Responsible Party):
Frauke Müller, University of Geneva, Switzerland

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.

Condition or disease Intervention/treatment Phase
Edentulous Complete Denture Wearers Device: Implant placement Procedure: Conventional reline Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Implant-supported Mandibular Overdentures in Very Old Adults - a Randomized Controlled Trial
Study Start Date : September 2007
Actual Primary Completion Date : April 2012
Estimated Study Completion Date : April 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dentures

Arm Intervention/treatment
Experimental: implant placement
insertion of 2 interforaminal mandibular implants and conversion of the lower complete denture to an implant-overdenture
Device: Implant placement
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.
Other Names:
  • Straumann Standard Implants® (SLA surface, 8mm length, RN, 4.1mm diameter)
  • Locator® attachments (Zest Anchors: Escondido, CA, USA)

Active Comparator: denture reline
conventional reline of mandibular complete denture
Procedure: Conventional reline
conventional reline of the existing mandibular complete denture




Primary Outcome Measures :
  1. Change from Baseline in Denture satisfaction [ Time Frame: at 3, 12, 24 and 36 months ]
    VAS-scale score to evaluate the subjective satisfaction with the denture


Secondary Outcome Measures :
  1. Change from Baseline in OHRQoL [ Time Frame: at 3, 12, 24 adn 36 months ]
    OHIP-Edent questionnaire, 20 questions

  2. Change from Baseline in cognitive function [ Time Frame: at 12, 24 and 36 months ]
    Mini-Mental State Examination, to evaluate cognitive function (Folstein et al. 1975) Trail-making test A and B Verbal fluency test

  3. Change from Baseline in Independence [ Time Frame: at 12, 24 and 36 months ]
    IADL Instrumental Activities of Daily Living Scale (Lawton and Brody, 1969) MIF Measure of functional independence

  4. Change from Baseline in MNA [ Time Frame: at 3, 12, 24 and 36 months ]
    Mini-nutritional Assessement questionnaire (Guigoz 1994)

  5. Change from Baseline in Blood markers [ Time Frame: at 3, 12, 24 and 36 months ]
    Albumin, Folic acid, Vitamin B12 (VitB12), Hemoglobin (Hb), C-reactive protein (CRP)

  6. Change from Baseline in BMI [ Time Frame: at 12, 24 and 36 months ]
    Body Mass Index kg/m2

  7. Change from Insertion in implant survival [ Time Frame: at 3, 12, 24 and 36 months ]
    inserted implants in vivo

  8. Change from Insertion in Pocket depth [ Time Frame: at 3, 12, 24 and 36 months ]
    mesial and distal peri-implant probing depth

  9. Change from Insertion in Plaque index [ Time Frame: at 3, 12, 24 and 36 months ]
    Plaque index on implants (Silness & Loe 1963) Denture plaque index

  10. Change from Insertion in peri-implant bone loss [ Time Frame: at 3, 12, 24 and 36 months ]
    mesial and distal peri-implant bone loss, as evaluated on intraoral radiographs or OPTs

  11. Change from Baseline in Chewing efficiency [ Time Frame: at Intervention, 3, 12, 24 and 36 months ]
    two color mixing test with bi-colored chewing gum (Schimmel et al 2007)

  12. Change from Baseline in Maximum bite force [ Time Frame: at Intervention, 3, 12, 24 and 36 months ]
    unilateral maximal bite force measured with force gauge

  13. Change from Baseline in Stimulated Saliva Flow Rate [ Time Frame: at Intervention, 3, 12, 24 and 36 months ]
    whole saliva collected after chewing wax for 2 minutes on one side

  14. Changes from Baseline in Masseter Muscle Thickness [ Time Frame: at 3, 12, 24 and 36 months ]
    ultrasound measurements of the masseter muscle thickness in contracted and relaxed state



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Ages Eligible for Study:   75 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01928004


Locations
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Switzerland
University of Geneva
Geneva, Switzerland, 1205
Sponsors and Collaborators
University Hospital, Geneva
University of Geneva, Switzerland
Investigators
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Principal Investigator: Frauke Müller, Prof. Dr. med. dent. University of Geneva
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Frauke Müller, Professor and Chair, University of Geneva, Switzerland
ClinicalTrials.gov Identifier: NCT01928004    
Other Study ID Numbers: MDGPA_02
ITI_458_2006 ( Other Grant/Funding Number: International Team of Implantology ITI )
First Posted: August 23, 2013    Key Record Dates
Last Update Posted: July 13, 2016
Last Verified: July 2016
Keywords provided by Frauke Müller, University of Geneva, Switzerland:
edentulous
complete denture
Additional relevant MeSH terms:
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Mouth, Edentulous
Mouth Diseases
Stomatognathic Diseases
Tooth Diseases