Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-26 @ 4:27 AM
Study NCT ID:
NCT02769260
Status:
UNKNOWN
Last Update Posted:
2016-05-11
First Post:
2016-04-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Biofilm Characteristics Between an in Situ Biofilm Model of Supragingival Plaque and Natural Teeth
Sponsor:
University of Santiago de Compostela
Organization:
Study Overview
Official Title:
Comparison of Biofilm Characteristics Between an in Situ Biofilm Model of Supragingival Plaque and Natural Teeth
Status:
UNKNOWN
Status Verified Date:
2016-05
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine in situ the bacterial viability, thickness and bacterial diversity of a biofilm formed on different substrates in comparison to a naturally tooth-formed oral biofilm. In addition, it will be evaluated whether the restraint of oral hygiene measures may influence the development of the PL-Biofilm.
Detailed Description:
* To calculate an a priori sample size, the following statistical criteria were established: an effect size of 0.35, an alpha error of 0.05 and a statistical power of 87%. Assuming these criteria and using the repeated measures ANOVA test, a sample size of 15 subjects was required.
* Bacterial viability and thickness will be analyse by Confocal Laser Scanning Microscope and Live/Dead BackLight staining solution.
* Bacterial diversity will be analyse by Pyrosequencing the 16S DNAr gene.
* Bacterial viability and thickness will be analyse by Confocal Laser Scanning Microscope and Live/Dead BackLight staining solution.
* Bacterial diversity will be analyse by Pyrosequencing the 16S DNAr gene.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: