NCT06753162

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
4,079

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2023

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

December 18, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 31, 2024

Completed
Last Updated

January 1, 2025

Status Verified

December 1, 2024

Enrollment Period

5 months

First QC Date

December 18, 2024

Last Update Submit

December 30, 2024

Conditions

Keywords

endometriosisOral HealthPeriodontitisGengivitis

Outcome Measures

Primary Outcomes (3)

  • Response Patterns Based on Multiple Correspondence Analysis Dimensions

    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).

    1 year

  • Epidemiological Analysis

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

    1 year

  • Comparative Analysis of Oral Cavity Disorders Across Different Stages of Endometriosis

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

    1 year

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women suffering from endometriosis

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Bari Aldo Moro

Bari, 70124, Italy

Location

MeSH Terms

Conditions

EndometriosisPeriodontitis

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • Saverio Capodiferro, Professor

    University of Bari Aldo Moro

    STUDY DIRECTOR
  • Massimo Corsalini, Professor

    University of Bari Aldo Moro

    STUDY DIRECTOR
  • Giuseppe D'Albis

    University of Bari Aldo Moro

    PRINCIPAL INVESTIGATOR
  • Agneta Maria Teresa

    University of Bari Aldo Moro

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

December 18, 2024

First Posted

December 31, 2024

Study Start

January 1, 2023

Primary Completion

June 1, 2023

Study Completion

December 1, 2024

Last Updated

January 1, 2025

Record last verified: 2024-12

Locations