NCT05849415

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
203

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 28, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 29, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 8, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 17, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 18, 2024

Completed
Last Updated

February 28, 2024

Status Verified

February 1, 2024

Enrollment Period

9 months

First QC Date

April 29, 2023

Last Update Submit

February 25, 2024

Conditions

Keywords

Periodontal disease

Outcome Measures

Primary Outcomes (3)

  • Periodontal health assessment

    Periodontal Screening and Recording and percentage of bleeding on probing.

    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.

    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.

    4 month

Secondary Outcomes (1)

  • relationship between periodontal health status and psychological tests

    4 month

Interventions

Periodontal probing for the evaluation of bleeding on probing and Periodontal Screening and Recording

Also known as: Sheldon Cohen Perceived Stress Scale (PSS), Mindfulness Awareness Attention Scale (MAAS)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

European people

You may qualify if:

  • Aged \> 18

You may not qualify if:

  • 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);

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Giuseppe D'Albis

Mola di Bari, Bari, 70042, Italy

Location

MeSH Terms

Conditions

Periodontal DiseasesMucositis

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesGastroenteritisGastrointestinal DiseasesDigestive System Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 29, 2023

First Posted

May 8, 2023

Study Start

February 28, 2023

Primary Completion

November 17, 2023

Study Completion

February 18, 2024

Last Updated

February 28, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations