ParodontitisPARADIESNCT07135076
PARodontitis And Type 2 DIabetes in Elderly Subjects
An observational study of Parodontitis and Type2 Diabetes, run by German Institute of Human Nutrition at 2 sites in Germany.
Trial summary
PARADIES is a cross-sectional observational study on Parodontitis and Type-2-diabetes. Its purpose is to collect data on the prevalence of Parodontitis and Type-2-diabetes in a regular out-patient setting, to provide insight into predictive conditions (such as comorbidities, blood parameters, clinical symptoms etc.) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parodontitis, Type2 Diabetes
- How many people
- 1,296 participants
- Where
- 2 sitesGermany
- Study dates
- 1 Jul 2017to 31 Dec 2019
- 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
- No healthy volunteers
- Adult, Older adult
Study population: type-2-diabetes patients from an out-patient endocrinologist in Hameln, Germany
Who may be able to join
- type-2-diabetes
Who cannot join
- none
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
German Institut for Human Nutrition; Department for Clinical Nutrition
Bergholz-Rehbrücke, Brandenburg, 14458
DIfE (German Institute for Human Nutrition)
Berlin, 12203
About this study
PARADIES is a cross-sectional observational study on Parodontitis and Type-2-diabetes. Its purpose is to collect data on the prevalence of Parodontitis and Type-2-diabetes in a regular out-patient setting, to provide insight into predictive conditions (such as comorbidities, blood parameters, clinical symptoms etc.)
Read the detailed description
PARADIES is a cross-sectional observational study on Parodontitis and Type-2-diabetes. Its purpose is to collect data on the prevalence of Parodontitis and Type-2-diabetes in a regular out-patient setting, to provide insight into predictive conditions (such as comorbidities, blood parameters, clinical symptoms etc.).
Data is collected once only, includes questionnaires on dental symptoms and dental condition, dental hygiene, general clinical anamnesis, recent state of routine blood parameters and medication.
- Conditions
- Parodontitis, Type2 Diabetes
- Medical subject headings
- Dry Socket
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| type 2 diabetes | patients are examined for symptoms (questionnaire) and clinical signs of parodontitis (PSI), data from the individual dentists are collected, too |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survey on prevalence of confirmed and assumed parodontitis / parodontitis stages, stratified by type of diabetes and sex
prevalence of confirmed and assumed parodontitis / parodontitis stages, stratified by type of diabetes and sex
Measured: baseline
Survey on co-prevalence of confirmed / assumed parodontitis / parodontitis stages with hypertension, depression and diabetic microvascular complications
co-prevalence of confirmed / assumed parodontitis / parodontitis stages with hypertension, depression and diabetic microvascular complications
Measured: baseline
Questionnaire on prediction analysis on prevalence of confirmed and assumed parodontitis / parodontitis stages
prediction analysis on prevalence of parodontitis / parodontitis stages based on type of diabetes, diabetes duration / diabetes onset, sex, co-morbidities, metabolic state (BMI, fasting glucose, HbA1c, diabetes medication), smoking, dental hygiene and compliance, quality of life
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2025
- Study start1 Jul 2017
- Primary completion1 Jul 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ParodontitisStudies 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
- Cross-sectional
- Enrolment
- 1,296 participants (actual)
Sponsor and investigators
- Lead sponsor
- German Institute of Human Nutrition
- Sponsor type
- University, hospital or other
- Collaborators
- Praxis am Posthof, Hameln, Germany
- Responsible party
- Principal investigator, Prof. Dr. med. Andreas F. H. Pfeiffer, German Institute of Human Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07135076
- Sponsor's protocol ID
- PARADIES
- Acronym
- PARADIES
- Status last verified
- Jul 2020
- First submitted
- 21 Jul 2020
- Last updated
- 21 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PARodontitis And Type 2 DIabetes in Elderly Subjects
- ClinicalTrials.gov ID
- NCT07135076
- Acronym / sponsor ID
- PARADIES / PARADIES
- Conditions
- Parodontitis, Type2 Diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,296 participants (actual)
- Lead sponsor
- German Institute of Human NutritionUniversity, hospital or other
- Collaborators
- Praxis am Posthof, Hameln, Germany
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 21 Aug 2025 (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.
PARADIES is a cross-sectional observational study on Parodontitis and Type-2-diabetes. Its purpose is to collect data on the prevalence of Parodontitis and Type-2-diabetes in a regular out-patient setting, to provide insight into predictive conditions (such as comorbidities, blood parameters, clinical symptoms etc.)
Detailed description
PARADIES is a cross-sectional observational study on Parodontitis and Type-2-diabetes. Its purpose is to collect data on the prevalence of Parodontitis and Type-2-diabetes in a regular out-patient setting, to provide insight into predictive conditions (such as comorbidities, blood parameters, clinical symptoms etc.).
Data is collected once only, includes questionnaires on dental symptoms and dental condition, dental hygiene, general clinical anamnesis, recent state of routine blood parameters and medication.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| type 2 diabetes | – | –patients are examined for symptoms (questionnaire) and clinical signs of parodontitis (PSI), data from the individual dentists are collected, too |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- type-2-diabetes patients from an out-patient endocrinologist in Hameln, Germany
Key inclusion criteria (1 listed)
- type-2-diabetes
Key exclusion criteria (1 listed)
- none
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
Survey on prevalence of confirmed and assumed parodontitis / parodontitis stages, stratified by type of diabetes and sex
Time frame: baseline
prevalence of confirmed and assumed parodontitis / parodontitis stages, stratified by type of diabetes and sex
Survey on co-prevalence of confirmed / assumed parodontitis / parodontitis stages with hypertension, depression and diabetic microvascular complications
Time frame: baseline
co-prevalence of confirmed / assumed parodontitis / parodontitis stages with hypertension, depression and diabetic microvascular complications
Questionnaire on prediction analysis on prevalence of confirmed and assumed parodontitis / parodontitis stages
Time frame: baseline
prediction analysis on prevalence of parodontitis / parodontitis stages based on type of diabetes, diabetes duration / diabetes onset, sex, co-morbidities, metabolic state (BMI, fasting glucose, HbA1c, diabetes medication), smoking, dental hygiene and compliance, quality of life
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 21 Aug 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parodontitis and Type2 Diabetes, run by German Institute of Human Nutrition at 2 sites in Germany.
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: finished, as of the sponsor's last update on 21 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. 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?
Survey on prevalence of confirmed and assumed parodontitis / parodontitis stages, stratified by type of diabetes and sex (time frame: baseline). 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 21 Aug 2025.