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Clinical Trials/NCT02769260
NCT02769260
Unknown
Early Phase 1

Comparison of Biofilm Characteristics Between an in Situ Biofilm Model of Supragingival Plaque and Natural Teeth

University of Santiago de Compostela1 site in 1 country15 target enrollmentSeptember 2015

Overview

Phase
Early Phase 1
Intervention
Not specified
Conditions
Biofilm
Sponsor
University of Santiago de Compostela
Enrollment
15
Locations
1
Primary Endpoint
Bacterial viability
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2015
End Date
June 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Inmaculada Tomas

Senior Lecture

University of Santiago de Compostela

Eligibility Criteria

Inclusion Criteria

  • systemically healthy
  • good oral health status

Exclusion Criteria

  • smoker or former smoker,
  • presence of dental prostheses or orthodontic devices,
  • antibiotic treatment or routine use of oral antiseptics in the previous 3 months,
  • presence of any systemic disease that could alter the production or composition of saliva

Outcomes

Primary Outcomes

Bacterial viability

Time Frame: Bacterial viability measured in proportion of viable/no viable bacteria after 48 hours of exposition to oral cavity

It will be measured by analysis of images taken by Confocal laser Scanning Microscope

Bacterial diversity

Time Frame: Bacterial diversity measured by microbial estimators of abundance and richness after 48 hours of exposition to oral cavity

It will be measured by 16S rDNA gene pyrosequencing and posterior bioinformatic analysis.

Secondary Outcomes

  • Biofilm thickness(Oral biofilm thickness measured by analysis of sectional images after 48 hours of exposition to oral cavity)

Study Sites (1)

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