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

Phase 4

• Conditions: K02; Dental caries

• Registration Number: DRKS00011067
• Lead Sponsor: Septodont

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09-15
• Study Completion: 2017-05-11
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 10

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

•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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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