- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT05129826
The Association Between Periodontal Disease and Malnutrition in a Group of Elderly People in Thailand.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Ageing may accompany with an accumulation of diseases and impairments cause by physiological, socioeconomic and psychological changes. The older adults are more prone to nutritional deficiencies due to combination of factors such as ageing, excessive polypharmacy, general health decline, poor socioeconomic status, cognitive decline, poor appetite, impaired efficacy of swallowing and limit eating ability.
Periodontitis is a multifactorial disease predominantly a bacterial infection involving the dental biofilm or dental plaque. Periodontitis increases in extent and severity across a large proportion of the human population with ageing. The effects of ageing on the immune system include distinct alterations in both innate and adaptive immune-cell function and effector biomolecules, resulting in processes reflecting immunosenescence, immunoactivation and inflammaging. Moreover, genetic contribution alters immunity and inflammation that play a role in the dysregulation of host responses in ageing. The combination of chronic antigenic burden and uncontrolled inflammatory response can enhance immunosenescence and ageing-associated disease. Periodontitis also has an effect on food intake, nutritional status and quality of life in older adults.
However the relationship between chronic periodontitis and malnutrition in older adult is not clear and needs further study. In this study will be determine the association between periodontitis and malnutrition status in older adult.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
-
Bangkok, Thailand, 10400
- Kanyawat Rattanasuwan
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Subjects who has aged ≥ 60 years old.
- Subjects who not receive periodontal treatment within the previous 6 months.
- Subjects who are able to read Thai and express verbal communication.
- Subjects who are functional independent older adults (get ≥ 12 points from Barthel Index for Activities of Daily Living) [50, 51].
- Subjects who are cognitive functional independent older adults (get > 23 points from Thai Mental State Examination) [52].
Exclusion Criteria:
- Subjects with completely edentulous area.
- Subjects who require antibiotic prophylaxis for dental examination
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Screening
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: older adult
Subjects who has aged ≥ 60 years old.
|
be determine the association between periodontitis and malnutrition status in older adult.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Nutritional status
Tidsramme: 1 hour
|
The nutritional status of the participants will be measured by MNA (Mini Nutritional Assessment) questionnaire.
The participants with scores ≥ 24 were classified as having a normal nutritional status, 17 to 23.5 were classified as at risk of malnutrition and <17 were classified as malnutrition.
|
1 hour
|
|
Periodontal status
Tidsramme: 2 hour
|
The probing pocket depth and clinical attachment level were collected by clinical data collection.
The participants who had 4 or more teeth with 1 or more sites with PPD ≥ 4 mm and with clinical attachment loss ≥ 3 mm at the same site was diagnosed as periodontitis.
|
2 hour
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Variables that associated with malnutrition in older adult.
Tidsramme: 1 month
|
The variables that may be associated with malnutrition in all participants were collected.
Including, the sociodemographic data and health behavioral information were collected by questionnaires.
The anthropometric measurements, masticatory ability, periodontal status, number of teeth and functional tooth units were recorded.
The complete data was analyzed for the associated with malnutrition.
|
1 month
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Kanyawat Rattanasuwan, Department of Oral Medicine and Periodontology, Faculty of Dentistry, Mahidol University.
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- MU-DT/PY-IRB 2019/051.1408
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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 .