Sixth German Oral Health Study - Modules 5.2/6.1
Organizational Data
- DRKS-ID:
- DRKS00028701
- Recruitment Status:
- Recruiting complete, study complete
- Date of registration in DRKS:
- 2022-04-27
- Last update in DRKS:
- 2024-05-07
- Registration type:
- Prospective
Acronym/abbreviation of the study
DMS 6 (5.2/6.1)
URL of the study
No Entry
Brief summary in lay language
Cohort study in split-panel design Module 5.2: First Follow-up Survey/Second Wave of the DMS V. The DMS V is a longitudinal oral epidemiological and social science research and interview survey at a nationally representative level Module 6.1: Baseline survey of the DMS - 6. The DMS - 6 is a longitudinal oral epidemiological and social science research and interview survey on a nationally representative level.
Brief summary in scientific language
Title of the study: Sixth German Oral Health Study (DMS - 6). Modules 5.2 and 6.1 Research Questions: Cross-sectional questions 1 What are the current prevalences of oral diseases? 2. What are the associations between oral health and other subject characteristics? Trend questions 3. What is the trend in oral health in Germany from 1989 to 2023? Longitudinal questions 4. How do oral diseases change over the course of life? 5. Which subject characteristics influence the development of oral (new) diseases as well as the progression of these diseases? Study type: Cohort study in split-panel design Module 5.2: First follow-up/second wave of the DMS V. The DMS V is a longitudinal oral epidemiologic and social science examination and survey survey on a nationally representative level Module 6.1: Baseline survey of the DMS - 6. The DMS - 6 is a longitudinal oral epidemiological and social science survey of investigation and interviewing at a nationally representative level. Basic Population: Module 5.2: 20-year-olds 43- to 52-year-olds 73- to 82-year-olds in Germany Module 6.1: 12-year-olds 35- to 44-year-olds 65- to 74-year-olds in Germany Sampling model: Disproportionately stratified random sample 1st step: Area sample (sample points) 2nd step: Sampling of persons (residents' registration office) Target variables: Caries (prevalence and extent) Periodontitis (staging and grading) Edentulism (prevalence) other oral diseases Duration of examination: Total time spent in the examination center: 45 minutes Of which dental examination: 20-30 minutes Evaluation strategy / statistical models: prevalences and 95% confidence intervals; association analyses and risk factor analyses using mixed models; descriptive statistics (means and standard deviations, median and quartiles, absolute and relative frequencies); group comparisons using appropriate statistical hypothesis tests. GEP-Conformity: The present study will be conducted according to the study protocol and in compliance with Good Epidemiological Practice, including archiving of the necessary documents. Financing: Modules 5.2 and 6.1 of DMS - 6 are funded by the BZÄK and the KZBV.
Health condition or problem studied
- ICD10:
- K05 - Gingivitis and periodontal diseases
- ICD10:
- K02 - Dental caries
- Healthy volunteers:
- Yes
Interventions, Observational Groups
- Arm 1:
- Intraoral examination and sociological survey Field time: October 2022 - September 2023 Cross-sectional questions 1 What are the current prevalences of oral diseases? 2. What are the associations between oral health and other subject characteristics? Trend questions 3. What is the trend in oral health in Germany from 1989 to 2023? Longitudinal questions 4. How do oral diseases change over the course of life? 5. Which subject characteristics influence the development of oral (new) diseases as well as the progression of these diseases? Module 5.2: First follow-up/second wave of the DMS V. The DMS V is a longitudinal oral epidemiologic and social science examination and survey survey on a nationally representative level Module 6.1: Baseline survey of the DMS - 6. The DMS - 6 is a longitudinal oral epidemiological and social science survey of investigation and interviewing at a nationally representative level. Basic Population: Module 5.2: 20-year-olds 43- to 52-year-olds 73- to 82-year-olds in Germany Module 6.1: 12-year-olds 35- to 44-year-olds 65- to 74-year-olds in Germany Sampling model: Disproportionately stratified random sample 1st step: Area sample (sample points) 2nd step: Sampling of persons (residents' registration office) Target variables: Caries (prevalence and extent) Periodontitis (staging and grading) Edentulism (prevalence) other oral diseases Duration of examination: Total time spent in the examination center: 45 minutes Of which dental examination: 20-30 minutes
Endpoints
- Primary outcome:
- Target variables: Caries (prevalence and extent) Periodontitis (staging and grading) edentulism (prevalence) Cross-sectional questions 1. What are the current prevalences of oral diseases? 2. What are the associations between oral health and other subject characteristics? Trend question 3. What is the trend in oral health in Germany from 1989 to 2023? Longitudinal question 4. How do oral diseases change over the course of life? 5. Which subject characteristics influence the development of oral (new) diseases and the progression of these diseases?
- Secondary outcome:
- other oral diseases
Study Design
- Purpose:
- Other
- Retrospective/prospective:
- No Entry
- Study type:
- Non-interventional
- Longitudinal/cross-sectional:
- No Entry
- Study type non-interventional:
- Epidemiological study
Recruitment
- Recruitment Status:
- Recruiting complete, study complete
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Multicenter study
- Recruitment location(s):
-
- Other Öffentliche Einrichtungen öffentliche Einrichtungen: Halle/Saale, Erlangen, Göggingen, Gerbstedt, Sonderhofen, Karlsruhe, Bibertal/Bubesheim, Haldensleben, Tutzing, Lahr, Hamburg, Großhansdorf, Köln, Oberhausen, Cremlingen,...
Recruitment period and number of participants
- Planned study start date:
- 2022-10-04
- Actual study start date:
- 2022-10-04
- Planned study completion date:
- 2023-06-03
- Actual Study Completion Date:
- 2023-09-23
- Target Sample Size:
- 4500
- Final Sample Size:
- 3768
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 12 Years
- Maximum Age:
- 82 Years
- Additional Inclusion Criteria:
- Module 6.1: - The target person is registered in one of the randomly selected sample points. - The target person is born in the years o 2010 (12-year-olds) OR o 1978-1987 (35- to 44-year-olds) OR o 1948-1957 (65- to 74-year-olds) - The written declaration of consent of the custodians of the target person and the target person is available. Module 5.2: - The target person participated in the DMS V (predecessor study 2014) and has been included in the panel of the DMS V has been. - The written declaration of consent of the custodians of the target person and the target person is available.
Exclusion Criteria
- The target person or his/her guardians do not have sufficient knowledge of German to participate in the study. - Legal requirements.
Addresses
Primary Sponsor
- Address:
- Bundeszahnärztekammer (BZÄK) Arbeitsgemeinschaft der Deutschen Zahnärztekammern e.V. und Kassenzahnärztliche Bundesvereinigung (KZBV) Körperschaft des öffentlichen Rechts50931 KölnGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Institut der Deutschen ZahnärzteProf. A. Rainer JordanUniversitätsstraße 7350931 KölnGermany
- Telephone:
- 0221400114142
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Contact for Public Queries
- Address:
- Institut der Deutschen ZahnärzteProf. A. Rainer JordanUniversitätsstraße 7350931 KölnGermany
- Telephone:
- 0221400114142
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Principal Investigator
- Address:
- Institut der Deutschen ZahnärzteProf. A. Rainer JordanUniversitätsstraße 7350931 KölnGermany
- Telephone:
- 0221400114142
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Sources of Monetary or Material Support
Private sponsorship (foundations, study societies, etc.)
- Address:
- Kassenzahnärztliche Bundesvereinigung (KZBV)Körperschaft des öffentlichen Rechts50931 KölnGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Private sponsorship (foundations, study societies, etc.)
- Address:
- Bundeszahnärztekammer (BZÄK) Arbeitsgemeinschaft der Deutschen Zahnärztekammern e.V.10115 BerlinGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Ethics Committee
Address Ethics Committee
- Address:
- Ethik-Kommission der Universität Witten/HerdeckeAlfred-Herrhausen-Str. 5058448 WittenGermany
- Telephone:
- +49-2302-926740
- Fax:
- +49-2302-926739
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2021-10-21
- Ethics committee number:
- S-249/2021
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2021-12-01
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- März/April 2025
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry