- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05129826
The Association Between Periodontal Disease and Malnutrition in a Group of Elderly People in Thailand.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Bangkok, Thailand, 10400
- Kanyawat Rattanasuwan
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: older adult
Subjects who has aged ≥ 60 years old.
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be determine the association between periodontitis and malnutrition status in older adult.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Nutritional status
Time Frame: 1 hour
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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.
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1 hour
|
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Periodontal status
Time Frame: 2 hour
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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.
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2 hour
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Variables that associated with malnutrition in older adult.
Time Frame: 1 month
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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.
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1 month
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Kanyawat Rattanasuwan, Department of Oral Medicine and Periodontology, Faculty of Dentistry, Mahidol University.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MU-DT/PY-IRB 2019/051.1408
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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