Plain English Summary
Background and study aims
Dental caries, or cavities, are one of the most common long-term health conditions worldwide. They are thought to be caused by a buildup of bacteria on the tooth surface (biofilm), which produces substances that lead to tooth decay. It is still a challenge for dentists to assess current caries in a patient, as it is only after a few months that the damage to the tooth becomes visible. There is evidence to suggest that it is not the presence of bacteria alone that leads to caries but the type of bacteria present. The aim of this study is to compare the composition of biofilms (bacteria) living in the mouths of people suffering from caries and those who are not.
Who can participate?
Healthy adults with three or more caries in need of treatment and healthy adults without caries who have had no new fillings in the last two years.
What does the study involve?
For eight hours, participants are asked to wear a mouth piece made from cattle teeth on their upper jaw so that a biofilm can form undisturbed. Samples of saliva in the mouth are taken after two, four and eight hours. These are then tested in the laboratory in order to assess the bacteria living in the both, which is then compared between the participants with caries and those without.
What are the possible benefits and risks of participating?
There are no direct benefits or risks involved with participating.
Where is the study run from?
1. Clinic of Operative Dentistry, Periodontology and Preventive Dentistry, Saarland University Medical Center (Germany)
2. Policlinic of Operative and Pediatric Dentistry, Carl Gustav Carus TU Dresden (Germany)
When is the study starting and how long is it expected to run for?
July 2009 to September 2016
Who is funding the study?
Deutsche Forschungsgemeinschaft (Germany)
Who is the main contact?
Professor Stefan Rupf
stefan.rupf@uks.eu
Trial website
Contact information
Type
Scientific
Primary contact
Prof Stefan Rupf
ORCID ID
http://orcid.org/0000-0002-1551-9935
Contact details
Clinic of Operative Dentistry
Periodontology and Preventive Dentistry
Saarland University
Homburg
66421
Germany
+49 68411624962
stefan.rupf@uks.eu
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
HA 5192/7-1, HA 2718/11-1, RU 866/2-1
Study information
Scientific title
Comparison of initial oral microbiomes of caries actives and caries inactives using a dynamic in situ biofilm model in young adults
Acronym
Study hypothesis
The aim of this study is to compare the microbial composition in caries active and caries inactive adults for 2, 4 and 8 hours in in situ biofilms and saliva.
Ethics approval
1. Ethics Committies of the Saarland University, 03/09/2009, ref: Sn52/05/2009
2. Dresden University, 19/10/2012, ref: EK275092012
Study design
Observational case-control study
Primary study design
Observational
Secondary study design
Case-control study
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
Only available in German and not available in web format, please use the contact details below to request a patient information sheet
Condition
Dental caries
Intervention
Twenty-seven volunteers are enrolled in the study, 14 caries active individuals with at least three active dentin caries lesions and 13 caries inactive individuals.
Polished bovine enamel slabs mounted in buccal direction on acrylic splints are worn by all volunteers in their upper jaws for in situ biofilm formation for eight hours and 1 ml of unstimulated saliva is collected after two, four and eight hours from each individual. Amplicon sequencing of the V1 and V2 variable regions of the 16S rRNA gene is performed on saliva samples using MiSeq. Differentially abundant operational taxonomic units (OTUs) are identified using the Wilcoxon-Mann-Whitney test. Random forests are used for sample classification and evaluated by cross-validation.
Intervention type
Genetic
Phase
Drug names
Primary outcome measures
Differences in the biofilms are assessed by amplicon sequencing of the V1 and V2 variable regions of the 16S rRNA gene using MiSeq on samples collected at 2, 4 and 8 hours.
Secondary outcome measures
No secondary outcome measures
Overall trial start date
01/07/2009
Overall trial end date
16/09/2016
Reason abandoned
Eligibility
Participant inclusion criteria
Test group caries active:
1. Aged between 18 and 45
2. Minimum 24 teeth
3. Written informed consent
4. Recruitment in the outpatient departments of Saarland and Dresden Universities
5. Sufficient oral hygiene (plaque index < 50%, bleeding index < 15%)
6. Three or more active caries lesions (need of invasive treatment)
Control group caries inactive:
1. Aged between 18 and 45
2. Minimum 24 teeth
3. Written informed consent
4. Recruitment in the outpatient departments of Saarland and Dresden Universities
5. Sufficient oral hygiene (plaque index < 50%, bleeding index < 15%)
6. No active caries lesions, no new fillings within the last 2 years
Participant type
Healthy volunteer
Age group
Adult
Gender
Both
Target number of participants
24
Participant exclusion criteria
1. Smokers
2. Pregnancy
3. Drug use
4. Periodontal disease
5. Other oral diseases except caries
6. Other diseases and conditions
Recruitment start date
01/01/2013
Recruitment end date
31/12/2014
Locations
Countries of recruitment
Germany
Trial participating centre
Saarland University Medical Center
Clinic of Operative Dentistry, Periodontology and Preventive Dentistry
Building 73
Homburg
66421
Germany
Trial participating centre
Policlinic of Operative and Pediatric Dentistry
Carl Gustav Carus TU Dresden
Fetscherstraße 74
Dresden
01307
Germany
Funders
Funder type
Research organisation
Funder name
Deutsche Forschungsgemeinschaft
Alternative name(s)
German Research Foundation, DFG
Funding Body Type
private sector organisation
Funding Body Subtype
foundation
Location
Germany
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer reviewed journal.
IPD Sharing plan:
The datasets generated during and/or analysed during the current study are/will be available upon request from Professor Stefan Rupf (stefan.rupf@uks.eu)
Intention to publish date
16/09/2016
Participant level data
Available on request
Results - basic reporting
Publication summary