Periodontal DiseasesNCT05129826
The Association Between Periodontal Disease and Malnutrition in a Group of Elderly People in Thailand.
A study testing the association between periodontitis and malnutrition status in people with Periodontal Diseases and Malnutrition, run by Mahidol University at 1 site in Thailand.
Trial summary
This study will be determine the association between periodontitis and malnutrition status in older adult. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Periodontal Diseases, Malnutrition
- What is being tested?
- the association between periodontitis and malnutrition status
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteThailand
- Study dates
- 1 Nov 2019to 1 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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].
Who cannot join
- Subjects with completely edentulous area.
- Subjects who require antibiotic prophylaxis for dental examination
Trial locations and contacts
1 site in 1 country.
About this study
This study will be determine the association between periodontitis and malnutrition status in older adult.
Read the 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.
- Conditions
- Periodontal Diseases, Malnutrition
- Being tested
- the association between periodontitis and malnutrition status
- Keywords
- periodontal disease, malnutrition, older adult
- Medical subject headings
- Periodontal Diseases, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the association between periodontitis and malnutrition statusBehavioural
be determine the association between periodontitis and malnutrition status in older adult.
| Study group | Role | What they receive |
|---|---|---|
| older adult | Experimental | Subjects who has aged ≥ 60 years old. Receives: Behavioral: the association between periodontitis and malnutrition status |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 hour
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.
Measured: 2 hour
Secondary outcomes (1)
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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2021
- Study start1 Nov 2019
- Primary completion1 Apr 2021
- Study completion1 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseasesStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kanyawat Rattanasuwan, Principal investigator, Department of Oral Medicine and Periodontology, Faculty of Dentistry, Mahidol University.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05129826
- Sponsor's protocol ID
- MU-DT/PY-IRB 2019/051.1408
- Status last verified
- Nov 2021
- First submitted
- 20 Sep 2021
- Last updated
- 22 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association Between Periodontal Disease and Malnutrition in a Group of Elderly People in Thailand.
- ClinicalTrials.gov ID
- NCT05129826
- Acronym / sponsor ID
- MU-DT/PY-IRB 2019/051.1408
- Conditions
- Periodontal Diseases, Malnutrition
- Keywords
- periodontal disease, malnutrition, older adult
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- 1 May 2021 (actual)
- First posted
- 22 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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).
| Arm | Type | Receives |
|---|---|---|
| older adult | Experimental | Behavioral: the association between periodontitis and malnutrition statusSubjects who has aged ≥ 60 years old. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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].
Key exclusion criteria (2 listed)
- Subjects with completely edentulous area.
- Subjects who require antibiotic prophylaxis for dental examination
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| the association between periodontitis and malnutrition statusbe determine the association between periodontitis and malnutrition status in older adult. | Behavioural | older adult |
Primary outcome
Nutritional status
Time frame: 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.
Periodontal status
Time frame: 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.
1 secondary outcome
Variables that associated with malnutrition in older adult.
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kanyawat Rattanasuwan principal investigator
Department of Oral Medicine and Periodontology, Faculty of Dentistry, Mahidol University.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing the association between periodontitis and malnutrition status in people with Periodontal Diseases and Malnutrition, run by Mahidol University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nutritional status (time frame: 1 hour). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2021; AzTrials last refreshed its copy on 8 Nov 2026.