- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01928004
Mandibular Implants in Elderly Patients
27. april 2021 opdateret af: Frauke Müller, University of Geneva, Switzerland
Implant-supported Mandibular Overdentures in Very Old Adults - a Randomized Controlled Trial
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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
45
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Geneva, Schweiz, 1205
- University of Geneva
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
75 år og ældre (Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: implant placement
insertion of 2 interforaminal mandibular implants and conversion of the lower complete denture to an implant-overdenture
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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.
Andre navne:
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Aktiv komparator: denture reline
conventional reline of mandibular complete denture
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conventional reline of the existing mandibular complete denture
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Change from Baseline in Denture satisfaction
Tidsramme: at 3, 12, 24 and 36 months
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VAS-scale score to evaluate the subjective satisfaction with the denture
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at 3, 12, 24 and 36 months
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Change from Baseline in OHRQoL
Tidsramme: at 3, 12, 24 adn 36 months
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OHIP-Edent questionnaire, 20 questions
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at 3, 12, 24 adn 36 months
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Change from Baseline in cognitive function
Tidsramme: at 12, 24 and 36 months
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Mini-Mental State Examination, to evaluate cognitive function (Folstein et al. 1975) Trail-making test A and B Verbal fluency test
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at 12, 24 and 36 months
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Change from Baseline in Independence
Tidsramme: at 12, 24 and 36 months
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IADL Instrumental Activities of Daily Living Scale (Lawton and Brody, 1969) MIF Measure of functional independence
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at 12, 24 and 36 months
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Change from Baseline in MNA
Tidsramme: at 3, 12, 24 and 36 months
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Mini-nutritional Assessement questionnaire (Guigoz 1994)
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at 3, 12, 24 and 36 months
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Change from Baseline in Blood markers
Tidsramme: at 3, 12, 24 and 36 months
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Albumin, Folic acid, Vitamin B12 (VitB12), Hemoglobin (Hb), C-reactive protein (CRP)
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at 3, 12, 24 and 36 months
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Change from Baseline in BMI
Tidsramme: at 12, 24 and 36 months
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Body Mass Index kg/m2
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at 12, 24 and 36 months
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Change from Insertion in implant survival
Tidsramme: at 3, 12, 24 and 36 months
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inserted implants in vivo
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at 3, 12, 24 and 36 months
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Change from Insertion in Pocket depth
Tidsramme: at 3, 12, 24 and 36 months
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mesial and distal peri-implant probing depth
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at 3, 12, 24 and 36 months
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Change from Insertion in Plaque index
Tidsramme: at 3, 12, 24 and 36 months
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Plaque index on implants (Silness & Loe 1963) Denture plaque index
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at 3, 12, 24 and 36 months
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Change from Insertion in peri-implant bone loss
Tidsramme: at 3, 12, 24 and 36 months
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mesial and distal peri-implant bone loss, as evaluated on intraoral radiographs or OPTs
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at 3, 12, 24 and 36 months
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Change from Baseline in Chewing efficiency
Tidsramme: at Intervention, 3, 12, 24 and 36 months
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two color mixing test with bi-colored chewing gum (Schimmel et al 2007)
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at Intervention, 3, 12, 24 and 36 months
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Change from Baseline in Maximum bite force
Tidsramme: at Intervention, 3, 12, 24 and 36 months
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unilateral maximal bite force measured with force gauge
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at Intervention, 3, 12, 24 and 36 months
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Change from Baseline in Stimulated Saliva Flow Rate
Tidsramme: at Intervention, 3, 12, 24 and 36 months
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whole saliva collected after chewing wax for 2 minutes on one side
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at Intervention, 3, 12, 24 and 36 months
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Changes from Baseline in Masseter Muscle Thickness
Tidsramme: at 3, 12, 24 and 36 months
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ultrasound measurements of the masseter muscle thickness in contracted and relaxed state
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at 3, 12, 24 and 36 months
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Frauke Müller, Prof. Dr. med. dent., University of Geneva
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. september 2007
Primær færdiggørelse (Faktiske)
1. april 2012
Studieafslutning (Faktiske)
1. april 2019
Datoer for studieregistrering
Først indsendt
16. august 2013
Først indsendt, der opfyldte QC-kriterier
20. august 2013
Først opslået (Skøn)
23. august 2013
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
30. april 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
27. april 2021
Sidst verificeret
1. april 2021
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- MDGPA_02
- ITI_458_2006 (Andet bevillings-/finansieringsnummer: International Team of Implantology ITI)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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