Periodontal DiseasesNCT05849415
Periodontal Health and Its Relationship With Psychological Stress
An observational study of Periodontal Diseases and Stress, run by D'Albis Dental at 1 site in Italy.
Trial summary
Studies suggest that chronic exposure to psychological stress can lead to oral health deterioration, alter the immune response, and possibly contribute to increased inflammation, which can impact the physiological healing of periodontal tissues. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Periodontal Diseases, Stress, Mucositis
- What is being tested?
- Periodontal Screening and Recording, periodontal evaluation.
- How many people
- 203 participants
- Where
- 1 siteItaly
- Study dates
- 28 Feb 2023to 18 Feb 2024
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: European people
Who may be able to join
- Aged > 18
Who cannot join
- Pregnancy
- administration of antibiotics in the last 15 days prior to study entry or indications for antibiotic prophylaxis;
- orthodontic appliances
- immunological diseases or use of drugs that can affect oral tissues, (phenytoin, cyclosporine), nifedepine, chronic use of non-steroidal anti-inflammatory drugs);
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Correlation Between Periodontal Health, Psychological Stress and Mindfulness Awareness
Studies suggest that chronic exposure to psychological stress can lead to oral health deterioration, alter the immune response, and possibly contribute to increased inflammation, which can impact the physiological healing of periodontal tissues.
People with psychophysiological stress disorders tend to acquire unhealthy habits, leading to less self-care, incorrect nutrition, smoking, alcohol consumption, and reduced physical activity.
Read more
This cross-sectional study aims to evaluate the correlation between periodontal health and psychological stress.
Patients between the ages of 35 and 70 will be recruited. Each patient must be visited and a periodontal assessment must be performed, recording the percentage of bleeding on probing and the Periodontal Screening and Recording (PSR). Subsequently, patients will be administered the Sheldon Cohen Perceived Stress Scale (PSS) and the Mindfulness Awareness Attention Scale (MAAS) questionnaires.
- Conditions
- Periodontal Diseases, Stress, Mucositis, Periodontal
- Being tested
- Periodontal Screening and Recording, periodontal evaluation.
- Keywords
- Periodontal disease
- Medical subject headings
- Periodontal Diseases, Mucositis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Periodontal Screening and Recording, periodontal evaluation.Diagnostic test
Also called Sheldon Cohen Perceived Stress Scale (PSS), Mindfulness Awareness Attention Scale (MAAS)
Periodontal probing for the evaluation of bleeding on probing and Periodontal Screening and Recording
What is being measured
The primary outcome is the main question the study is designed to answer.
Periodontal health assessment
Periodontal Screening and Recording and percentage of bleeding on probing.
Measured: 4 month
Sheldon Cohen Perceived Stress Scale (PSS)
The questionnaire consists of 10 questions regarding feelings and thoughts made during the last month. Possible answers have a value ranging from 0 to 4 based on the severity or frequency with which the person has thought in a certain way. For each question, the alternatives are as follows: 0 - never 1 - almost never 2 - sometimes 3 - fairly often 4 - very often. Therefore, the total score can range from 0 to 40. The range between 0 and 13 represents a perceived stress value that is either nonexistent or mild and well managed. The range between 14 and 26 represents a moderate stress value that can negatively affect physical and mental health. The range between 27 and 40 represents a perceived stress value that is severe and significantly compromises physical and mental health.
Measured: 4 month
Mindfulness Awareness Attention Scale (MAAS)
Total score can range from 0 to 15. To measure the scale, one simply needs to calculate the average of the 15 responses.Higher scores reflect higher levels of disposition towards Mindfulness.
Measured: 4 month
Secondary outcomes (1)
relationship between periodontal health status and psychological tests
The results will be analyzed
Measured: 4 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2023
- Study start28 Feb 2023
- Primary completion17 Nov 2023
- Study completion18 Feb 2024
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.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 203 participants (actual)
Sponsor and investigators
- Lead sponsor
- D'Albis Dental
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bari Aldo Moro
- Responsible party
- Principal investigator, Giuseppe D'Albis, DDS, University of Bari Aldo Moro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05849415
- Sponsor's protocol ID
- periodontology-stress
- Status last verified
- Feb 2024
- First submitted
- 29 Apr 2023
- Last updated
- 28 Feb 2024
- 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 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Periodontal Health, Psychological Stress and Mindfulness Awareness
- ClinicalTrials.gov ID
- NCT05849415
- Acronym / sponsor ID
- periodontology-stress
- Conditions
- Periodontal Diseases, Stress, Mucositis, Periodontal
- Keywords
- Periodontal disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 203 participants (actual)
- Lead sponsor
- D'Albis DentalUniversity, hospital or other
- Collaborators
- University of Bari Aldo Moro
- Study start
- 28 Feb 2023 (actual)
- Primary completion
- 17 Nov 2023 (actual)
- Study completion
- 18 Feb 2024 (actual)
- First posted
- 8 May 2023 (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.
Studies suggest that chronic exposure to psychological stress can lead to oral health deterioration, alter the immune response, and possibly contribute to increased inflammation, which can impact the physiological healing of periodontal tissues.
People with psychophysiological stress disorders tend to acquire unhealthy habits, leading to less self-care, incorrect nutrition, smoking, alcohol consumption, and reduced physical activity.
This cross-sectional study aims to evaluate the correlation between periodontal health and psychological stress.
Patients between the ages of 35 and 70 will be recruited. Each patient must be visited and a periodontal assessment must be performed, recording the percentage of bleeding on probing and the Periodontal Screening and Recording (PSR). Subsequently, patients will be administered the Sheldon Cohen Perceived Stress Scale (PSS) and the Mindfulness Awareness Attention Scale (MAAS) questionnaires.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- European people
Key inclusion criteria (1 listed)
- Aged > 18
Key exclusion criteria (4 listed)
- Pregnancy
- administration of antibiotics in the last 15 days prior to study entry or indications for antibiotic prophylaxis;
- orthodontic appliances
- immunological diseases or use of drugs that can affect oral tissues, (phenytoin, cyclosporine), nifedepine, chronic use of non-steroidal anti-inflammatory drugs);
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 |
|---|---|---|
| Periodontal Screening and Recording, periodontal evaluation.Also: Sheldon Cohen Perceived Stress Scale (PSS), Mindfulness Awareness Attention Scale (MAAS)Periodontal probing for the evaluation of bleeding on probing and Periodontal Screening and Recording | Diagnostic test | – |
Primary outcome
Periodontal health assessment
Time frame: 4 month
Periodontal Screening and Recording and percentage of bleeding on probing.
Sheldon Cohen Perceived Stress Scale (PSS)
Time frame: 4 month
The questionnaire consists of 10 questions regarding feelings and thoughts made during the last month. Possible answers have a value ranging from 0 to 4 based on the severity or frequency with which the person has thought in a certain way. For each question, the alternatives are as follows: 0 - never 1 - almost never 2 - sometimes 3 - fairly often 4 - very often. Therefore, the total score can range from 0 to 40. The range between 0 and 13 represents a perceived stress value that is either nonexistent or mild and well managed. The range between 14 and 26 represents a moderate stress value that can negatively affect physical and mental health. The range between 27 and 40 represents a perceived stress value that is severe and significantly compromises physical and mental health.
Mindfulness Awareness Attention Scale (MAAS)
Time frame: 4 month
Total score can range from 0 to 15. To measure the scale, one simply needs to calculate the average of the 15 responses.Higher scores reflect higher levels of disposition towards Mindfulness.
1 secondary outcome
relationship between periodontal health status and psychological tests
Time frame: 4 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 28 Feb 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Periodontal Diseases and Stress, run by D'Albis Dental at 1 site in Italy.
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 1 inclusion and 4 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 28 Feb 2024. 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 Italy. 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?
Periodontal health assessment (time frame: 4 month). The study lists 3 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 28 Feb 2024.