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

Early Phase 1

• Conditions: Biofilm; Dental Plaque
• Interventions: Other: Toothbrushing

• Registration Number: NCT02769260
• Lead Sponsor: University of Santiago de Compostela

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.

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2016-04-20
• Status Verified: 2016-05
• Primary Completion: 2016-05
• Study First Submitted QC: 2016-05-08
• Last Update Submitted: 2016-05-08
• Study First Posted: 2016-05-11
• Last Update Posted: 2016-05-11
• Study Completion: 2016-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Toothbrushing during experiment	Toothbrushing	48hours-Dental plaque samples will be analyse by CLSM (confocal Laser scanning microscope).

Primary Outcome Measures

Name	Time	Method
Bacterial viability	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	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 Outcome Measures

Name	Time	Method
Biofilm thickness	Oral biofilm thickness measured by analysis of sectional images after 48 hours of exposition to oral cavity	It will be measured by analysing sectional images taken by Confocal Laser Scanning Microscope.

Trial Locations

Locations (1)

Univeristy of Santiago de Compostela, Faculty of Dentistry; 🇪🇸 Santiago de Compostela, Galicia/ A Coruña, Spain