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Completed

NCT Number: NCT06753162

Oral Health and Endometriosis: A Cohort Study

A survey has been conducted thanks to a questionnaire composed of 45 questions. The study group was composed of 4079 women affected by endometriosis, recruited from dedicated communities present on the social network Facebook. The questionnaire investigated about: the endometriosis status, the kind of therapy, the presence of any sign and symptoms in the oral cavity, the presence of periodontal problems, the self-perception of the oral health status, the presence of other autoimmune diseases and oral hygiene and the eating habits, physical activity practiced, the life quality.

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Key information

Conditions

Endometriosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Mouth Diseases Periodontal Diseases Periodontitis Stomatognathic Diseases Urogenital Diseases

Sex eligibility

Female

Study type

Observational

Primary location

University of Bari Aldo Moro

Bari, 70124, Italy

About this study

The questions were structured thanks to the collaboration of expert health professionals: gynecologist, dentist, dental hygienist, physiotherapist, dietician, psychologist to obtain targeted information on endometriosis, on the type of therapy, on any signs and symptoms in the oral cavity (perception health status, presence of periodontal problems), to investigate oral hygiene and dietary habits, physical activity, quality of life, the presence of other immune-based diseases. In the final part of the questionnaire there was a section in which women were free to tell their stories.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The only inclusion criterion was being at least 18 years old

Exclusion criteria

  • • Pregnancy.
  • Administration of antibiotics in the last 15 days prior to entry into the study or indications for antibiotic prophylaxis.
  • Orthodontic Appliances.
  • Immunological diseases or use of drugs that can affect oral tissues (phenytoin, cyclosporine), nifedipine, chronic use of nonsteroidal anti-inflammatory drugs.
  • Refusal to participate in the study.

Treatment and study plan

Primary outcomes

  1. Response Patterns Based on Multiple Correspondence Analysis Dimensions

    Time frame: 1 year

    To evaluate the possible correlations between endometriosis and the perception of periodontal disease, a score was created to summarize on a numerical scale the responses to survey questions describing the perception of oral cavity disorders. Multiple Correspondence Analysis (MCA) was used to explore relationships between responses. For the MCA, only questions with a p-value < 0.25 in the univariate analysis were included. The responses to the questions were labeled as "yes," "no," and "I don't know". In the case of question Q11, a grade was assigned to the responses as follows: "Idk" (I don't know), "Grd0" (Insufficient), "Grd1" (Average), "Grd2" (Good), "Grd3" (Very Good), and "Grd4" (Perfect).

  2. Epidemiological Analysis

    Time frame: 1 year

    It was statistically evaluated whether the severity of endometriosis increased significantly with age.

  3. Comparative Analysis of Oral Cavity Disorders Across Different Stages of Endometriosis

    Time frame: 1 year

    The correlation between general gum bleeding and the stage of the disease was statistically evaluated.

Sponsors and collaborators

Lead sponsor

University of Bari Aldo Moro

Other

Registry information

Official study title

Oral Health Perception Among 4,079 Women With Endometriosis: A Cohort Study

Acronym: Oral-Endomet

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Dec 31, 2024
Registry last updated
Jan 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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