NCT07135076

Brief 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.)

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,296

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2017

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 21, 2020

Completed
5.1 years until next milestone

First Posted

Study publicly available on registry

August 21, 2025

Completed
Last Updated

August 21, 2025

Status Verified

July 1, 2020

Enrollment Period

2 years

First QC Date

July 21, 2020

Last Update Submit

August 20, 2025

Conditions

ParodontitisType2 Diabetes

Outcome Measures

Primary Outcomes (3)

  • 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

    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

    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

    baseline

Study Arms (1)

type 2 diabetes

patients are examined for symptoms (questionnaire) and clinical signs of parodontitis (PSI), data from the individual dentists are collected, too

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

type-2-diabetes patients from an out-patient endocrinologist in Hameln, Germany

You may qualify if:

  • type-2-diabetes

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

German Institut for Human Nutrition; Department for Clinical Nutrition

Bergholz-Rehbrücke, Brandenburg, 14458, Germany

Location

DIfE (German Institute for Human Nutrition)

Berlin, 12203, Germany

Location

MeSH Terms

Conditions

Dry Socket

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Department of Clinical Nutrition

Study Record Dates

First Submitted

July 21, 2020

First Posted

August 21, 2025

Study Start

July 1, 2017

Primary Completion

July 1, 2019

Study Completion

December 31, 2019

Last Updated

August 21, 2025

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

DE(2)