Caries diagnostic using dental plaque and next generation sequencing

• Register: ISRCTN
• Last refreshed on: 6 February 2017
• Main ID: ISRCTN27083576
• Date of registration: 05/01/2017
• Prospective Registration: No
• Primary sponsor: Deutsche Forschungsgemeinschaft
• Public title: Caries diagnostic using dental plaque and next generation sequencing
• Scientific title: Comparison of initial oral microbiomes of caries actives and caries inactives using a dynamic in situ biofilm model in young adults
• Date of first enrolment: 01/01/2013
• Target sample size: 24
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN27083576
• Study type: Observational
• Study design: Observational case-control study (Prevention)

Countries of recruitment

Germany

Contacts

• Name: Stefan Rupf

Key inclusion & exclusion criteria

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
Exclusion criteria: 1. Smokers
2. Pregnancy
3. Drug use
4. Periodontal disease
5. Other oral diseases except caries
6. Other diseases and conditions

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Dental caries
Oral Health
Dental caries

Intervention(s)

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.

Primary Outcome(s)

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(s)

No secondary outcome measures

Secondary ID(s)

HA 5192/7-1, HA 2718/11-1, RU 866/2-1

Source(s) of Monetary Support

Deutsche Forschungsgemeinschaft