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Determination of the Antibacterial effect of Clearfil Protect Bond in-vivo – Identification of Polybacterial 16S rRNA genes in caries samples by T-RFLP and direct sequencing

Determination of the Antibacterial effect of Clearfil Protect Bond in-vivo – Identification of Polybacterial 16S rRNA genes in caries samples by T-RFLP and direct sequencing

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00011532
Enrollment
10
Registered
2017-02-13
Start date
2017-01-09
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

K02.1 K02.9

Interventions

Group 1: Application of Clearfil Protect Bond (Kuraray), a self-etching adhesive, which is known to have antibacterial effect beneath ist adhesive function which is dued to its ingredient, the antibac

Sponsors

Universitätsklinikum Leipzig
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: •primary caries lesions at 2 (or more) molars or premolars with indication for a stepwise or partial caries removal (regardless of the present trial). Two of the lesions will be included into the study. -clinical picture: ICDAS 4, 5 or 6 -extension in the X-ray picture: R4 (inner half of the dentin) -no pulpal symptoms of the teeth to be included into the study -maintained sensibility of the study teeth •informed consent

Exclusion criteria

Exclusion criteria: • known history of intolerance towards one of the adhesive systems or one of their ingredients • unability of determining study outcome and probable consequences (e.g. because of alcoholism) • refusal to give consent • pregnancy, breastfeeding • inadequate adherence

Design outcomes

Primary

MeasureTime frame
Determination of the antibacterial effect of Clearfil Protect Bond on residual caries compared to Clearfil SE Bond 2. Sampling of carious material at the first visit and at a reentry after eight weeks. Samples are analyzed by microbiological and molecular biological methods (as described in the summary). Changes in microbiological composition are determined quantitatively (qPCR) as well as qualitatively.

Secondary

MeasureTime frame
Determination of the bacterial composition of progressed dentin caries lesions before and after partial caries removal and application of different therapy strategies

Countries

Germany

Contacts

Public ContactJana Schmidt

Poliklinik für Zahnerhaltung und Parodontologie

jana.schmidt@medizin.uni-leipzig.de0341/9721916

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 24, 2026