NCT02769260

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

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: University of Santiago de Compostela · Academic / Other
• Sex: All
• Age: 20 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Biofilm
• Dental Plaque

Interventions

Type	Name	Description
OTHER	Toothbrushing	Normal toothbrushing without toothpaste or antiseptic mouthwash.

Timeline

• Start date: 2015-09-01
• Primary completion: 2016-05-01
• Completion: 2016-06-01
• First posted: 2016-05-11
• Last updated: 2016-05-11

Locations

1 site across 1 country: Spain