EndometriosisOral-EndometNCT06753162
Oral Health and Endometriosis: A Cohort Study
An observational study of Endometriosis, run by University of Bari Aldo Moro at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometriosis
- How many people
- 4,079 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2023to 1 Dec 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Women suffering from endometriosis
Who may be able to join
- The only inclusion criterion was being at least 18 years old
Who cannot join
- • 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Oral Health Perception Among 4,079 Women With 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.
Read the detailed description
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.
- Conditions
- Endometriosis
- Keywords
- endometriosis, Oral Health, Periodontitis, Gengivitis
- Medical subject headings
- Endometriosis, Periodontitis
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 1 year
Epidemiological Analysis
It was statistically evaluated whether the severity of endometriosis increased significantly with age.
Measured: 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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2024
- Study start1 Jan 2023
- Primary completion1 Jun 2023
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 4,079 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bari Aldo Moro
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giuseppe D'Albis, University of Bari Aldo Moro
- Investigators
- Saverio Capodiferro, Professor, Study director, University of Bari Aldo MoroMassimo Corsalini, Professor, Study director, University of Bari Aldo MoroGiuseppe D'Albis, Principal investigator, University of Bari Aldo MoroAgneta Maria Teresa, Principal investigator, University of Bari Aldo Moro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06753162
- Sponsor's protocol ID
- endometriosis-oralhealt
- Acronym
- Oral-Endomet
- Status last verified
- Dec 2024
- First submitted
- 18 Dec 2024
- Last updated
- 1 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Health Perception Among 4,079 Women With Endometriosis: A Cohort Study
- ClinicalTrials.gov ID
- NCT06753162
- Acronym / sponsor ID
- Oral-Endomet / endometriosis-oralhealt
- Conditions
- Endometriosis
- Keywords
- endometriosis, Oral Health, Periodontitis, Gengivitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,079 participants (actual)
- Lead sponsor
- University of Bari Aldo MoroUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 31 Dec 2024 (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.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Women suffering from endometriosis
Key inclusion criteria (1 listed)
- The only inclusion criterion was being at least 18 years old
Key exclusion criteria (5 listed)
- • Pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
Epidemiological Analysis
Time frame: 1 year
It was statistically evaluated whether the severity of endometriosis increased significantly with age.
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.
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 1 Jan 2025.
- Individual participant dataSharing planned: Undecided
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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.
Saverio Capodiferro, Professor study director
University of Bari Aldo Moro
Massimo Corsalini, Professor study director
University of Bari Aldo Moro
Giuseppe D'Albis principal investigator
University of Bari Aldo Moro
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 Endometriosis, run by University of Bari Aldo Moro 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 5 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 1 Jan 2025. 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?
Response Patterns Based on Multiple Correspondence Analysis Dimensions (time frame: 1 year). 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 1 Jan 2025.