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Completed

NCT Number: NCT01928004

Mandibular Implants in Elderly Patients

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.

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Key information

Conditions

Edentulous Complete Denture Wearers Mouth Diseases Mouth, Edentulous Stomatognathic Diseases Tooth Diseases

Age range

75 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Geneva

Geneva, 1205, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Implant placement

Device

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)

Conventional reline

Procedure

conventional reline of the existing mandibular complete denture

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Geneva, Switzerland

Other

Registry information

Official study title

Implant-supported Mandibular Overdentures in Very Old Adults - a Randomized Controlled Trial

Important dates

Study start
2007
Primary completion
2012
Study completion
2019
First posted
Aug 23, 2013
Registry last updated
Apr 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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