Caries diagnostic using dental plaque and next generation sequencing

ISRCTN	ISRCTN27083576
DOI	https://doi.org/10.1186/ISRCTN27083576
Secondary identifying numbers	HA 5192/7-1, HA 2718/11-1, RU 866/2-1

Submission date: 03/01/2017
Registration date: 05/01/2017
Last edited: 05/01/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Oral Health

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

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

Contact information

Prof Stefan Rupf
Scientific

Clinic of Operative Dentistry
Periodontology and Preventive Dentistry
Saarland University
Homburg
66421
Germany

ORCID ID	0000-0002-1551-9935
Phone	+49 68411624962
Email	stefan.rupf@uks.eu

Study information

Study design	Observational case-control study
Primary study design	Observational
Secondary study design	Case-control study
Study setting(s)	Hospital
Study type	Prevention
Participant information sheet	Only available in German and not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Comparison of initial oral microbiomes of caries actives and caries inactives using a dynamic in situ biofilm model in young adults
Study objectives	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(s)	1. Ethics Committies of the Saarland University, 03/09/2009, ref: Sn52/05/2009 2. Dresden University, 19/10/2012, ref: EK275092012
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/07/2009
Completion date	16/09/2016

Eligibility

Participant type(s)	Healthy volunteer
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	24
Key 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
Key exclusion criteria	1. Smokers 2. Pregnancy 3. Drug use 4. Periodontal disease 5. Other oral diseases except caries 6. Other diseases and conditions
Date of first enrolment	01/01/2013
Date of final enrolment	31/12/2014

Locations

Countries of recruitment

Germany

Study participating centres

Saarland University Medical Center

Clinic of Operative Dentistry, Periodontology and Preventive Dentistry
Building 73
Homburg
66421
Germany

Policlinic of Operative and Pediatric Dentistry

Carl Gustav Carus TU Dresden
Fetscherstraße 74
Dresden
01307
Germany

Sponsor information

Deutsche Forschungsgemeinschaft
Research organisation

Kennedyallee 40
Bonn
53175
Germany

"ROR"	https://ror.org/018mejw64

Funders

Funder type

Research organisation

Deutsche Forschungsgemeinschaft
Government organisation / National government

Alternative name(s): German Research Association, German Research Foundation, DFG
Location: Germany

Results and Publications

Intention to publish date	16/09/2016
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
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)