Results List Study Search

DRKS00031815

Metabolic Profiling of oral Diseases

Organizational Data

DRKS-ID:
DRKS00031815
Recruitment Status:
Recruiting complete, study continuing
Date of registration in DRKS:
2023-05-05
Last update in DRKS:
2024-07-11
Registration type:
Retrospective

Acronym/abbreviation of the study

MetabOral

URL of the study

No Entry

Brief summary in lay language

Oral diseases in childhood, adolescence, and adulthood can affect not only the hard tissue of the teeth, the dental pulp, and the periodontal tissues but also the mucous membranes lining the oral cavity. Worldwide, caries and periodontitis are among the most common chronic diseases. To improve the prognosis for patients and to stop the progression of the diseases, it is important to detect them early, define their extent accurately, and initiate appropriate therapeutic measures. So far, these diseases are only visible when there is a clinical correlate such as a "hole". In the present study, a link between different molecular patterns in saliva and existing oral diseases will be established, which could contribute to early detection or more targeted therapeutic measures in the future. Moreover, the role of diet shall bei examined.

Brief summary in scientific language

The aim of this study is to gain insights into the saliva metabolome in various oral diseases and to incorporate these findings into the definition of corresponding disease-associated saliva metabolome patterns. To achieve this, saliva samples will be collected from children, adolescents, and adults at the University Hospital Heidelberg and will be characterized by NMR spectroscopy in terms of their metabolome pattern. All participants will receive a dietary questionnaire that captures their dietary behavior over the past four weeks to investigate possible effects of individual nutrient intake patterns on saliva metabolome and clinical parameters.

Health condition or problem studied

ICD-10-GM (translation):
K02 - Dental caries
ICD-10-GM (translation):
K03 - Other diseases of hard tissues of teeth
ICD-10-GM (translation):
K04 - Diseases of pulp and periapical tissues
ICD-10-GM (translation):
K05 - Gingivitis and periodontal diseases
ICD-10-GM (translation):
K00 - Disorders of tooth development and eruption
ICD-10-GM (translation):
K13 - Other diseases of lip and oral mucosa
Healthy volunteers:
No

Interventions, Observational Groups

Arm 1:
Adults, adolescents, and children with different oral diseases such as caries, periodontal diseases, endodontic diseases, and non-carious dental lesions. Saliva samples at one single timepoint.
Arm 2:
Adults, adolescents, and children with periodontitis who are undergoing systematic periodontitis therapy: Saliva samples will be taken at the time before the start of therapy, at the end of stage 1 of therapy (after 4-6 weeks), and immediately after subgingival therapy (after an additional 3-6 weeks).

Endpoints

Primary outcome:
Establishment of saliva metabolome profiles for different oral diseases.
Secondary outcome:
Correlation of the metabolome profile with other diseases as well as with nutritional factors (nutrient patterns).

Study Design

Purpose:
Diagnostic
Retrospective/prospective:
Prospective
Study type:
Non-interventional
Longitudinal/cross-sectional:
Cross-sectional study
Study type non-interventional:
No Entry

Recruitment

Recruitment Status:
Recruiting complete, study continuing
Reason if recruiting stopped or withdrawn:
No Entry

Recruitment Locations

Recruitment countries:
  • Germany
Number of study centers:
Monocenter study
Recruitment location(s):
  • University medical center Uniklinik Heidelberg, MZK-Klinik, Abteilung für Zahnerhaltungskunde Heidelberg

Recruitment period and number of participants

Planned study start date:
No Entry
Actual study start date:
2023-04-28
Planned study completion date:
2024-12-31
Actual Study Completion Date:
No Entry
Target Sample Size:
2000
Final Sample Size:
435

Inclusion Criteria

Sex:
All
Minimum Age:
no minimum age
Maximum Age:
no maximum age
Additional Inclusion Criteria:
Consent through written consent forms from the patients (18 years and older), the legal guardians (patients under 18 years old), or the legal representatives (incapable patients) of the patients.

Exclusion Criteria

No consent through written consent forms from the patients (18 years and older), the legal guardians (patients under 18 years old), or the legal representatives (incapable patients) of the patients.

Addresses

Primary Sponsor

Universitätsklinik Heidelberg, MZK-Klinik, Abteilung für Zahnerhaltungskunde
69120 Heidelberg
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry
Investigator Sponsored/Initiated Trial (IST/IIT):
Yes

Contact for Scientific Queries

Universitätsklinik Heidelberg, MZK-Klinik, Abteilung für Zahnerhaltungskunde
Dr. Valentin Bartha
Im Neuenheimer Feld 400
69120 Heidelberg
Germany
Telephone:
+406221566002
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Contact for Public Queries

Universitätsklinik Heidelberg, MZK-Klinik, Abteilung für Zahnerhaltungskunde
Dr. Valentin Bartha
Im Neuenheimer Feld 400
69120 Heidelberg
Germany
Telephone:
+406221566002
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Principal Investigator

Universitätsklinik Heidelberg, MZK-Klinik, Abteilung für Zahnerhaltungskunde
Dr. Valentin Bartha
Im Neuenheimer Feld 400
69120 Heidelberg
Germany
Telephone:
+406221566002
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Sources of Monetary or Material Support

Private sponsorship (foundations, study societies, etc.)

COURAGE Stiftung für chronisch kranke Kinder 69120 Heidelberg Deutschland
69120 Heidelberg
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Ethics Committee

Address Ethics Committee

Ethikkommission der Medizinischen Fakultät Heidelberg
Alte Glockengießerei 11/1
69115 Heidelberg
Germany
Telephone:
+49-6221-338220
Fax:
No Entry
Contact per E-Mail
URL:
http://www.medizinische-fakultaet-hd.uni-heidelberg.de/einrichtungen/zentrale-einrichtungen/ethikkommission

Vote of leading Ethics Committee

Date of ethics committee application:
2022-04-08
Ethics committee number:
S-554 / 2018
Vote of the Ethics Committee:
Approved
Date of the vote:
2023-04-13

Further identification numbers

Other WHO Primary Registry or Data Provider ID:
No Entry
EudraCT Number:
No Entry
UTN (Universal Trial Number):
No Entry
EUDAMED 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:
No Entry
Publications/study results:
No Entry
Date of the first journal publication of 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