Strategies to influence the initial oral microbiome to prevent secondary caries

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00027875

Enrollment

Registered

2022-02-09

Start date

2023-03-01

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

initial oral biofilm oral microbiome

Interventions

Group 1: Comparison of modified composites with standard filling composite: Test and control take place simultaneously in one subject (split-mouth design). For this purpose, the subjects wear a carr

Eligibility

Sex/Gender

All

Age

25 Years to 40 Years

Inclusion criteria

Inclusion criteria: - Age between 25 - 40 Years - Caries free - Periodontally healthy (Periodontial screening and recording index (PSR) < 1) und good oral hygiene (Silness-Löe plaque index (PI) < 1) - No systemic diseases

Exclusion criteria

Exclusion criteria: Subjects who do not meet the inclusion criteria

Design outcomes

Primary

Measure	Time frame
1. Amount of visible vital and non-vital bacteria: After removing the carrier splints, the test specimens are stained using the LIVE/DEAD® BacLight™ Bacterial Viability Kit (ThermoFisherScientific) and a subsequent image is taken under the vital fluorescence microscope (Keyence company). The entire area colonized by bacteria and the proportions of vital and non-vital bacteria are recorded under a microscope and quantified using the evaluation software (Hybrid Cell Count, Keyence Company).	—

Measure

Time frame

1. Amount of visible vital and non-vital bacteria: After removing the carrier splints, the test specimens are stained using the LIVE/DEAD® BacLight™ Bacterial Viability Kit (ThermoFisherScientific) and a subsequent image is taken under the vital fluorescence microscope (Keyence company). The entire area colonized by bacteria and the proportions of vital and non-vital bacteria are recorded under a microscope and quantified using the evaluation software (Hybrid Cell Count, Keyence Company).

—

Secondary

Measure	Time frame
2. Composition of the complete microbiome on the material surface: After removal of the carrier splints on a second day, the human and microbial cells adhering to the test specimens are lysed using chaotropic salt solution and the total genomic DNA contained is purified kit-based. Subsequently, the bacterial microbiome of the initial plaque obtained from the specimens is decoded by complete sequencing of the 16S rDNA. 3. Quantification of the known pioneer bacteria: Since the results of the NGS only indicate the relative composition of the microbiomes, a qPCR should be carried out for the determination of absolute quantities for the known initial bacterial colonizers. Thus, on a third day of wearing after removal of the carrier splints after obtaining the genomic DNA of a test body (see above), the initial pioneer germs of the plaque (S. oralis, S. mitis, S. sanguinis, S. gordonii, A. naeslundii and A. oris) quantified using species-specific real-time PCRs or probe-based TaqMan PCRs.	—

Measure

Time frame

2. Composition of the complete microbiome on the material surface: After removal of the carrier splints on a second day, the human and microbial cells adhering to the test specimens are lysed using chaotropic salt solution and the total genomic DNA contained is purified kit-based. Subsequently, the bacterial microbiome of the initial plaque obtained from the specimens is decoded by complete sequencing of the 16S rDNA. 3. Quantification of the known pioneer bacteria: Since the results of the NGS only indicate the relative composition of the microbiomes, a qPCR should be carried out for the determination of absolute quantities for the known initial bacterial colonizers. Thus, on a third day of wearing after removal of the carrier splints after obtaining the genomic DNA of a test body (see above), the initial pioneer germs of the plaque (S. oralis, S. mitis, S. sanguinis, S. gordonii, A. naeslundii and A. oris) quantified using species-specific real-time PCRs or probe-based TaqMan PCRs.

—

Countries

Germany

Contacts

Public ContactNiklas Burgard

Zentrum der Zahn-, Mund- und Kieferheilkunde (Carolinum)Goethe-Universität Frankfurt am MainPoliklinik für Zahnerhaltungskunde

burgard@med.uni-frankfurt.de06963016725

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026