Periodontal Health and Its Relationship With Psychological Stress

Stress Clinical Trial

Official title:

Correlation Between Periodontal Health, Psychological Stress and Mindfulness Awareness

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05849415
• Other study ID #: periodontology-stress
• Status: Completed
• Start date: February 28, 2023
• Est. completion date: February 18, 2024

Study information

• Verified date: February 2024
• Source: D'Albis Dental
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 203
• Est. completion date: February 18, 2024
• Est. primary completion date: November 17, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Aged > 18

Exclusion Criteria:

• 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);

Related Conditions & MeSH terms

• Mucositis
• Periodontal Diseases
• Stress
• Stress, Psychological

Intervention

Diagnostic Test:
• Periodontal Screening and Recording, periodontal evaluation.
Periodontal probing for the evaluation of bleeding on probing and Periodontal Screening and Recording

Locations

Country	Name	City	State
Italy	Giuseppe D'Albis	Mola di Bari	Bari

Sponsors (2)

Lead Sponsor	Collaborator
D'Albis Dental	University of Bari Aldo Moro

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Periodontal health assessment	Periodontal Screening and Recording and percentage of bleeding on probing.	4 month
Primary	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.	4 month
Primary	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.	4 month
Secondary	relationship between periodontal health status and psychological tests	The results will be analyzed	4 month