DiabetesNCT04991168
Relationship Between Oral Health and Diabetes
An observational study of Diabetes, run by University Hospital, Montpellier at 1 site in France.
Trial summary
The aim of this study is to assess the state of knowledge and practices in oral health of diabetic patients through the use of two questionnaires. It is also to analyse the link between the oral health status and the profile of diabetic patient, by carrying out an oral assessment for voluntary patients. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes
- What is being tested?
- Questionnaire
- Type of treatment
- Pill or oral medicine
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2021to 1 Apr 2022
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Diabetic patients over 18 coming to the CHU Lapeyronie
Who may be able to join
- All diabetic patients over 18 coming to the CHU Lapeyronie
Who cannot join
- -Non diabetic patients, diabetic patients under 18
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Uhmontpellier
Montpellier, 34295
Camille INQUIMBERT, Phd, 666957674 ext. 33, camille.inquimbert@gmail.com
Nicolas GIRAUDEAU, PhD, 616301126 ext. 33, nicolas.giraudeau@umontpellier.fr
About this study
Official title: Oral Health and Diabetes: Relationship Between Knowledge, Practices and Oral Health Status in Patients Followed in the Diabetes Department at the Montpellier University Hospital.
The aim of this study is to assess the state of knowledge and practices in oral health of diabetic patients through the use of two questionnaires. It is also to analyse the link between the oral health status and the profile of diabetic patient, by carrying out an oral assessment for voluntary patients.
- Conditions
- Diabetes
- Being tested
- Questionnaire
- Keywords
- Oral hygiene, Public Health, Patients coming to the CHU Lapeyronie for consultation or those being hospitalised there, Prevention, Telemedicine
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
Two questionnaires used to assess the state of knowledge and practices in oral health. An oral assessment will be carried out for voluntary patients.
| Study group | Role | What they receive |
|---|---|---|
| Diabetic patients over 18 from the CHU Lapeyronie | Diabetic patients over 18 from the CHU Lapeyronie Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral health knowledge and practice questionnaire score.
Oral health knowledge and practice questionnaire score.
Measured: 1 day
Number of missing and decayed teeth on the oral examination and clinical signs in diabetology.
Number of missing and decayed teeth on the oral examination and clinical signs in diabetology.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2021
- Study start1 Sep 2021
- Primary completion30 Jan 2022 (estimated)
- Study completion1 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Camille INQUIMBERT, PhD, Study director, University Hospital, MontpellierAmir MEZIANE, resident, Principal investigator, UH MONTPELLIER
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04991168
- Sponsor's protocol ID
- RECHMPL21_0504
- Status last verified
- Nov 2021
- First submitted
- 27 Jul 2021
- Last updated
- 2 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Health and Diabetes: Relationship Between Knowledge, Practices and Oral Health Status in Patients Followed in the Diabetes Department at the Montpellier University Hospital.
- ClinicalTrials.gov ID
- NCT04991168
- Acronym / sponsor ID
- RECHMPL21_0504
- Conditions
- Diabetes
- Keywords
- Oral hygiene, Public Health, Patients coming to the CHU Lapeyronie for consultation or those being hospitalised there, Prevention, Telemedicine
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 30 Jan 2022 (estimated)
- Study completion
- 1 Apr 2022 (estimated)
- First posted
- 5 Aug 2021 (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.
The aim of this study is to assess the state of knowledge and practices in oral health of diabetic patients through the use of two questionnaires. It is also to analyse the link between the oral health status and the profile of diabetic patient, by carrying out an oral assessment for voluntary patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diabetic patients over 18 from the CHU Lapeyronie | – | Other: QuestionnaireDiabetic patients over 18 from the CHU Lapeyronie |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Diabetic patients over 18 coming to the CHU Lapeyronie
Key inclusion criteria (1 listed)
- All diabetic patients over 18 coming to the CHU Lapeyronie
Key exclusion criteria (1 listed)
- -Non diabetic patients, diabetic patients under 18
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireTwo questionnaires used to assess the state of knowledge and practices in oral health. An oral assessment will be carried out for voluntary patients. | Other | Diabetic patients over 18 from the CHU Lapeyronie |
Primary outcome
Oral health knowledge and practice questionnaire score.
Time frame: 1 day
Oral health knowledge and practice questionnaire score.
Number of missing and decayed teeth on the oral examination and clinical signs in diabetology.
Time frame: 1 day
Number of missing and decayed teeth on the oral examination and clinical signs in diabetology.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2021.
- Individual participant dataSharing planned: Undecided. NC
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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.
Camille INQUIMBERT, PhD study director
University Hospital, Montpellier
Amir MEZIANE, resident principal investigator
UH MONTPELLIER
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 Diabetes, run by University Hospital, Montpellier at 1 site in France.
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 1 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: status not confirmed, as of the sponsor's last update on 2 Nov 2021. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Camille INQUIMBERT, PhD (666957674 ext. 33, camille.inquimbert@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oral health knowledge and practice questionnaire score. (time frame: 1 day). The study lists 2 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 2 Nov 2021.