The Association Between Periodontal Disease and Malnutrition in a Group of Elderly People in Thailand.
Primary Purpose
Periodontal Diseases, Malnutrition
Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
the association between periodontitis and malnutrition status
Sponsored by
About this trial
This is an interventional screening trial for Periodontal Diseases focused on measuring periodontal disease, malnutrition, older adult
Eligibility Criteria
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
Sites / Locations
- Kanyawat Rattanasuwan
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
older adult
Arm Description
Subjects who has aged ≥ 60 years old.
Outcomes
Primary Outcome Measures
Nutritional status
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.
Periodontal status
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.
Secondary Outcome Measures
Variables that associated with malnutrition in older adult.
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.
Full Information
NCT ID
NCT05129826
First Posted
September 20, 2021
Last Updated
November 11, 2021
Sponsor
Mahidol University
1. Study Identification
Unique Protocol Identification Number
NCT05129826
Brief Title
The Association Between Periodontal Disease and Malnutrition in a Group of Elderly People in Thailand.
Official Title
The Association Between Periodontal Disease and Malnutrition in a Group of Elderly People in Thailand.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
November 1, 2019 (Actual)
Primary Completion Date
April 1, 2021 (Actual)
Study Completion Date
May 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mahidol University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This study will be determine the association between periodontitis and malnutrition status in older adult.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontal Diseases, Malnutrition
Keywords
periodontal disease, malnutrition, older adult
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Subjects who has aged ≥ 60 years old, not receive periodontal treatment within the previous 6 months, able to read Thai and express verbal communication, functional independent older adults (get ≥ 12 points from Barthel Index for Activities of Daily Living) and cognitive functional independent older adults (get > 23 points from Thai Mental State Examination).
Masking
None (Open Label)
Masking Description
The questionnaire is completed through by the 1st researcher and all clinical data collection will be recorded by the 2nd researcher.
Allocation
N/A
Enrollment
78 (Actual)
8. Arms, Groups, and Interventions
Arm Title
older adult
Arm Type
Experimental
Arm Description
Subjects who has aged ≥ 60 years old.
Intervention Type
Behavioral
Intervention Name(s)
the association between periodontitis and malnutrition status
Intervention Description
be determine the association between periodontitis and malnutrition status in older adult.
Primary Outcome Measure Information:
Title
Nutritional status
Description
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.
Time Frame
1 hour
Title
Periodontal status
Description
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.
Time Frame
2 hour
Secondary Outcome Measure Information:
Title
Variables that associated with malnutrition in older adult.
Description
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.
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kanyawat Rattanasuwan
Organizational Affiliation
Department of Oral Medicine and Periodontology, Faculty of Dentistry, Mahidol University.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kanyawat Rattanasuwan
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Association Between Periodontal Disease and Malnutrition in a Group of Elderly People in Thailand.
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