Determination of the Antibacterial Effect of Biodentine in vivo - Identification of Polybacterial 16S rRNA Genes in Caries Samples by T-RFLP and Direct Sequencing

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

DRKS

Registry ID

DRKS00011067

Enrollment

Registered

2016-09-15

Start date

2016-02-10

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

Interventions

Group 1: Application of Biodentine (split mouth design) according to a stepwise caries excavation Group 2: Application of guttapercha according to a stepwise caries excavation

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: •Primary carious dentine lesions at 2 (or more) molars or premolars which are not in contact (e.g. in different sextants), indication to perform a stepwise caries therapy irrespective of the study -clinical Picture: according to the International Caries Detection and Assessment System (ICDAS) 4, 5 or 6 -complete isolation by rubberdam is possible -radiographic extension up to the inner half of the dentine (R4-lesions) -no clinical symptoms of the study teeth -positive sensitivity of the study teeth •in cases of carious lesion(s) or insufficient restoration margins in proximity of one of the study cavities: clinically acceptable restoration before trial conduction starts •signed informed consent

Exclusion criteria

Exclusion criteria: •cases of known intolerance of dental materials (or one of their ingrediences) applied in the study course •reasons which make it unlikely to be able to determine the outcome or probable consequences of the study (e.g. alcoholism, mental disability) •pregnancy, breastfeeding •evidence that keeping treatment appointments will not be able

Design outcomes

Primary

Measure	Time frame
Determination of the antibacterial effect of Biodentine when sealing residual caries after partial caries excavation. Quantification and qualification of reproducible bacteria (culture-dependent) and bacterial DNA (molecular biological by PCR, TRFLP and subsequent sequencing) before and after partial caries removal (stepwise caris therapy).	—

Secondary

Measure	Time frame
Intra- and interindividual differences considering microbiological composition in deep carious lesions before and 8 weeks after partial caries removal.	—

Countries

Germany

Contacts

Public ContactLaura Buenger

Poliklinik für Zahnerhaltung und Parodontologie, Universität Leipzig

laura.buenger@medizin.uni-leipzig.de0341/9721212

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 1, 2026